Atopic DermatitisPhase 3BREEZE-AD3NCT03334435
A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
A Phase 3 study testing Baricitinib in people with Atopic Dermatitis, run by Eli Lilly and Company at 185 sites in 19 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,645 participants
- Where
- 185 sitesin 19 countries
- Study dates
- 28 Mar 2018to 12 Jul 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
- Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
- Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
- Agree to use emollients daily.
Who cannot join
- Had investigational product permanently discontinued at any time during a previous Baricitinib study.
- Had temporary investigational product interruption continue at the final study visit of a previous Baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study
- OR
- Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:
- Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
- A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
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- Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
- Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
- Have been treated with the following therapies:
- Monoclonal antibody for less than 5 half-lives prior to randomization.
- Received prior treatment with any oral Janus kinase (JAK) inhibitor.
- Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
- Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
- Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
- Have had major surgery within the past eight weeks or are planning major surgery during the study.
- Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
- Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
- Have specific laboratory abnormalities.
- Have received certain treatments that are contraindicated.
- Pregnant or breastfeeding.
Trial locations and contacts
185 sites in 19 countries.
185 sites in 19 countries
Japan36 sites
Yanagihara dermatology clinic
Ainokawa, Ichikawa-shi, Chiba, 272-0143
Iidabashi Clinic
Chiyoda-ku, Tokyo, 102-0072
Tokyo Teishin Hospital
Chiyoda-Ku, Tokyo, 102-8798
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025
Hosono Clinic
Chuo-ku, Tokyo, 104-0031
Sumire Dermatology Clinic
Edogawa-ku, Tokyo, 133-0057
Fumimori Clinic
Fukuoka, Fukuoka, 815-0082
Gifu University Hospital
Gifu, 501-1194
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588
JA Shizuoka Kohseiren Enshu Hospital
Hamamatsu, Shizuoka, 430-0929
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Kawashima Dermatology Clinic
Ichikawa-shi, Chiba, 272-0033
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun, Ibaraki, 300-0395
Shimane University Hospital
Izumo, Shimane, 693-8501
Noguchi Dermatology
Kashima-machi, Kamimashiki-gun, Kumamoto, 861-3101
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506
Kurume University Hospital
Kurume, Fukuoka, 830 0011
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Medical Corporation Soleil Miyata Dermatology Clinic
Matsudo-shi, Chiba, 271-0092
Oizumi Hanawa Clinic
Nerima-ku, Tokyo, 178-0063
Yoshioka Dermatology Clinic
Neyagawa, Osaka, 572-0838
Kume Clinic
Nishi-ku Sakai-shi, Osaka, 593-8324
Queen's Square Dermatology and Allergology
Nishi-ku, Yokohama-city, Kanagawa, 220-6208
Sanrui Dermatology Clinic
Ohmiya-ku,Saitama-shi, Saitama, 330-0854
Osaka City University Hospital
Osaka, 545-8586
Shibaki Dermatology Clinic
Sapporo, Hokkaido, 006 0022
Sapporo Skin Clinic
Sapporo, Hokkaido, 060-0063
Naoko Dermatology Clinic
Setagaya-ku, Tokyo, 158-0097
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
NTT Medical Center Tokyo
Shinagawa-KU, Tokyo, 141-8625
Yamate Dermatological Clinic
Shinjuku, Tokyo, 169-0075
Tachikawa Dermatology Clinic
Tachikawa-shi, Tokyo, 190-0023
Shirasaki Clinic
Takaoka-shi, Toyama, 9330871
Senri-Chuo Hanafusa Dermatology Clinic
Toyonaka-shi, Osaka, 560-0085
Nomura Dermatology Clinic
Yokohama, Kanagawa, 221-0825
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682
Germany22 sites
Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik
Aachen, 52074
Charité Universitätsmedizin Berlin
Berlin, 10117
Rothhaar Studien GmbH
Berlin, 10783
ISA GmbH
Berlin, 10789
Praxis für Ganzheitliche Dermatologie im Ärztehaus
Berlin, 13055
Gemeinschaftspraxis Mahlow
Blankenfelde-Mahlow, Brandenburg, 15831
Dermatologisches Zentrum Osnabrück Nord
Bramsche, Lower Saxony, 49565
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt, Hesse, 64283
Praxis Gerlach
Dresden, Saxony, 01097
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075
TFS Trial Form Support GmbH
Hamburg, 20537
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
Universität Leipzig - Universitätsklinikum
Leipzig, Saxony, 04103
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Universitätsklinikum Otto-von-Guericke-Universität
Magdeburg, Saxony-Anhalt, 39120
Klinikum der Universität München
München, Bavaria, 80337
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, 18057
Poland13 sites
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
Bialystok, Podlaskie Voivodeship, 15-375
Centrum Badan Klinicznych, PI House
Gdansk, Pomeranian Voivodeship, 80-546
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611
Barbara Rewerska DIAMOND CLINIC
Krakow, Lesser Poland Voivodeship, 31-559
Dermed Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, 90-265
Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii
Olsztyn, Warmian-Masurian Voivodeship, 10-229
DermoDent, Centrum Medyczne Czajkowscy
Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031
Lubelskie Centrum Diagnostyczne
Świdnik, Lublin Voivodeship, 21-040
LASER CLINIC Specjalistyczne Gabinety Lekarskie
Szczecin, West Pomeranian Voivodeship, 70-332
Centrum Medyczne AMED
Warsaw, Masovian Voivodeship, 01-518
Centralny Szpital Kliniczny MSWiA
Warsaw, Masovian Voivodeship, 02-507
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, 02-625
Wojskowy Instytut Medyczny CSK MON
Warsaw, Masovian Voivodeship, 04-141
Spain11 sites
Hospital General Universitario Alicante
Alicante, 03010
Hospital Germans Trias i Pujol
Barcelona, Badalona, 08916
Hospital del Mar
Barcelona, 08003
Hospital De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35010
Hospital Infanta Leonor
Madrid, 28031
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933
Clinica Universitaria De Navarra
Pamplona, Navarre, 31008
Centro de Especialidades Mollabao
Pontevedra, 36001
Czechia9 sites
Fakultni Nemocnice U svate Anny
Brno, South Moravian, 656 91
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora, Central Bohemia, 28401
Nemocnice Novy Jicin a.s.
Nový Jičín, Moravian-Silesian Region, 741 01
Fakultni Nemocnice Plzen
Plzen-Bory, Plzeň Region, 305 99
Clintrial, s.r.o.
Prague, Hl. M. Praha, 100 00
Fakultni nemocnice Kralovske Vinohrady
Prague, Hl. M. Praha, 100 34
Fakultni Nemocnice v Motole
Prague, Hl. M. Praha, 150 06
Nemocnice Na Bulovce
Prague, Hl. M. Praha, 180 81
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, Ustecký Kraj, 40113
Hungary9 sites
UNO Medical Trials Kft.
Budapest, 1135
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, Hajdú-Bihar, 4032
Kaposi Mor Oktato Korhaz
Kaposvár, Somogy County, 7400
Oroshaza Varosi Onkormanyzat Korhaza
Orosháza, Bekes County, 5900
Trial Pharma Kft.
Püspökladány, Hajdú-Bihar, 4150
SZTE AOK Borgyogyaszati es Allergologiai Klinika
Szeged, Csongrád megye, 6720
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, 5000
Markusovszky Korhaz
Szombathely, Vas County, 9700
MedMare Bt
Veszprém, 8200
South Korea9 sites
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326
Gachon University Gil Medical Center
Incheon, Korea, 21565
Severance Hospital Yonsei University Health System
Seoul, 03722
Konkuk University Medical Center
Seoul, 05030
Seoul St. Mary's Hospital
Seoul, 06591
Chungang University Hospital
Seoul, 06973
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
India8 sites
Panchshil Hospital
Ahmedabad, Gujarat, 380005
Byramjee Jeejeebhoy Medical College & Civil Hospital
Ahmedabad, Gujarat, 380016
Seth GS Medical College & KEM Hospital
Mumbai, Maharshtra, 400012
Dr. D. Y. Patil Medical College & Hospital
Navi Mumbai, Maharashtra, 400706
All India Institue of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110 029
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Gandhi Hospital
Secunderabad, Telangana, 500003
King George Hospital
Vizag, Andhra Pradesh, 530002
Italy8 sites
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
Genova, 16132
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Azienda Ospedaliera - Universitaria Pisana
Pisa, 56126
Policlinico di Tor Vergata
Roma, 00133
Policlinico Univ. Agostino Gemelli
Rome, Lazio, 00168
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona, 37134
ULSS 8
Vicenza, 36100
Mexico8 sites
JM Research S.C.
Cuernavaca, 62290
RM Pharma Specialists S.A. de C.V.
Distrito Federal, 3100
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, 34000
Grupo Medico Camino S.C.
Mexico City, Mexico City, 03310
Hospital de Jesus I.A.P.
Mexico City, Mexico City, 06090
CRI Centro Regiomontano de Investigacion S.C.
Monterrey, Nuevo León, 64060
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
Clinica De Enfermedades Cronicas y Procedimientos Especiales
Morelia, Michoacan Morelia, CP 58249
Argentina7 sites
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1027AAP
CEDIC-Centro de Investigaciones Clinicas
Caba, Buenos Aires, C1425DES
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, C1055AA0
Fundacion CIDEA
Ciudad Autonoma Buenos Aires, C1121ABE
Instituto de Neumonología y Dermatología
Ciudad Autonoma Buenos Aires, C1425BEA
Psoriahue Medicina Interdisciplinaria
Ciudad Autonoma Buenos Aires, C1425DKG
Parra Dermatología
Mendoza, 5500
Australia7 sites
Clinical Trials SA Pty Ltd
Adelaide, South Australia, 5073
The Skin Centre
Benowa, Queensland, 4217
Skin and Cancer Foundation Inc.
Carlton, Victoria, 3053
Fremantle Dermatology
Perth, Western Australia, 6160
Woden Dermatology
Phillip, Australian Capital Territory, 2606
Skin & Cancer Foundation Australia
Westmead, New South Wales, 2145
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102
France7 sites
CHU de Bordeaux Hopital Saint Andre
Bordeaux, 33075
CHU Grenoble Alpes
Grenoble Cédex 9, 38043
Chru De Nantes Hotel-Dieu
Nantes, 44093
CHU de Nice Hopital de L'Archet
Nice, 06202
Hopital Saint-Louis
Paris, Cedex 10, 75475
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Hopital Larrey
Toulouse, 31059
Taiwan7 sites
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 83301
Taipei Medical University- Shuang Ho Hospital
New Taipei City, 23561
Chung Shan Medical University Hospital
Taichung, 40201
National Cheng Kung University Hospital
Tainan, 70403
National Taiwan University Hospital
Taipei, 10048
Chang Gung Memorial Hospital - Taipei
Taipei, 10508
Chang Gung Memorial Hospital - Linkou
Taoyuan, (r.o.c.), Taiwan, 33342
Austria6 sites
Universitätsklinikum Graz
Graz, Styria, 8036
Ordensklinikum Linz GmbH - Elisabethinen
Linz, Upper Austria, 4020
KA Rudolfstiftung
Vienna, 1030
AKH
Vienna, 1090
KH Hietzing mit neurologischem Zentrum Rosenhügel
Vienna, 1130
Sozialmed. Zentrum Ost - Donauspital
Vienna, 1220
Israel6 sites
Haemek Medical Center- Dermatology
Afula, 1834111
Rambam Medical Center
Haifa, 3525408
Hadassah Medical Center
Jerusalem, 91220
Rabin Medical Center
Petah Tikva, 4941492
Sheba Medical Center
Ramat Gan, 5265601
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Russia6 sites
GBUZ Clinical dermatology and venereological dispensary
Krasnodar, Krasnodarskiy Kray, 350020
State scientific centre for dermatovenerology and cosmetolog
Moscow, 107076
Russian state medical-stomatological university n.a. Evdokimov
Moscow, 111398
SPb SBHI Skin-venerologic dispensary #10
Saint Petersburg, 194021
LLC ArsVitae NorthWest
Saint Petersburg, 194223
LLC Medical Center "Kurator"
Saint Petersburg, 196240
Switzerland4 sites
Inselspital Bern
Bern, 3010
HUG-Hôpitaux Universitaires de Genève
Geneva, 1205
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Universitätsspital Zürich
Zurich, 8091
Denmark2 sites
Aarhus Universitehospital Marselisborg Centret
Aarhus, Region Midtjyland, 8200
Gentofte Hospital
Hellerup, Capital Region, 2900
About this study
Official title: A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.
Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.
- Conditions
- Atopic Dermatitis
- Being tested
- Baricitinib, Placebo
- Keywords
- eczema, atopic eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called LY3009104
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Responders and Partial Responders (RPR)-Placebo | Placebo comparator | Responders or partial responders (RPR) [Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally. Receives: Drug: Baricitinib; Drug: Placebo |
| RPR-Bari 1-milligram (mg) | Experimental | RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally. Receives: Drug: Baricitinib |
| RPR-Bari 2-mg | Experimental | RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally. Receives: Drug: Baricitinib |
| RPR-Bari 4-mg | Experimental | RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally. Receives: Drug: Baricitinib |
| Non-responders (NR): Bari 1 mg to 2 mg | Experimental | Non-responder (NR) [those not meeting definition of RPR] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally. Receives: Drug: Baricitinib |
| NR: Bari 1 mg to 4 mg | Experimental | NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally. Receives: Drug: Baricitinib |
| NR: Bari 2 mg to 2 mg | Experimental | NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally. Receives: Drug: Baricitinib |
| NR: Bari 2 mg to 4 mg | Experimental | NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally. Receives: Drug: Baricitinib |
| NR: Bari 4 mg to 4 mg | Experimental | NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally. Receives: Drug: Baricitinib |
| NR: Placebo to Bari 2 mg | Experimental | NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally. Receives: Drug: Baricitinib; Drug: Placebo |
| NR: Placebo to Bari 4 mg | Experimental | NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally. Receives: Drug: Baricitinib; Drug: Placebo |
| Placebo | Placebo comparator | Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally. Receives: Drug: Placebo |
| Bari 1 mg | Experimental | Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally. Receives: Drug: Baricitinib |
| Bari 2 mg | Experimental | Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally. Receives: Drug: Baricitinib |
| Bari 4 mg | Experimental | Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally. Receives: Drug: Baricitinib |
| Bari 2-mg Open-Label Addendum | Experimental | Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally. Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Measured: Weeks 16, 36 and 52
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Measured: Weeks 16, 36, and 52
Secondary outcomes (35)
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Measured: Weeks 16, 36, and 52
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Measured: Weeks 16, 36, and 52
Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Measured: Weeks 16, 36 and 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Measured: Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Measured: Weeks 16, 36, 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Measured: Weeks 16, 36, and 52
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Measured: Weeks 16, 36, and 52 Weeks
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Measured: Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Measured: Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Measured: Weeks 16, 36, and 52
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS)
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Measured: Week 16
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Measured: Week 16
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Measured: Week 16
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Measured: Week 16
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Measured: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Measured: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Measured: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Measured: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Measured: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Measured: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Measured: Week 16
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Measured: Week 16
Percentage of Participants Who Achieved a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Measured: Weeks 68, 104
Percentage of Participants Who Achieved a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Measured: Weeks 68, 104
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Measured: Weeks 68, 104
Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study)
Participants who entered the Substudy, relapsed with an IGA ≥3 and were retreated
Measured: Week 52 Up to Week 200
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Measured: Weeks 68, 104
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Measured: Weeks 68, 104
Percentage of Participants With a Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization(Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering Substudy With IGA 0 or 1)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Measured: Weeks 68, 104
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Measured: Week 68
Percentage of Participants With a Response of IGA 0 or 1 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Measured: Week 68
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Measured: Week 68
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Measured: Week 104
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Measured: Week 104
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Measured: Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start28 Mar 2018
- Primary completion21 Sep 2020
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334435
- Sponsor's protocol ID
- 16587
- Other IDs
- I4V-MC-JAHN, 2017-000873-35, 2017
- Acronym
- BREEZE-AD3
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2017
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Publications
Thyssen JP, Werfel T, Barbarot S, Hunter HJA, Pierce E, Sun L, Cirri L, Buchanan AS, Lu N, Wollenberg A. Maintained improvement in physician- and patient-reported outcomes with baricitinib in adults with moderate-to-severe atopic dermatitis who were treated for up to 104 weeks in a randomized trial. J Dermatolog Treat. 2023 Dec;34(1):2190430. doi: 10.1080/09546634.2023.2190430.
PubMed 36912484Reich K, Simpson E, Wollenberg A, Bissonnette R, Abe M, Cardillo T, Janes J, Sun L, Chen S, Silverberg JI. Efficacy of downtitration or treatment withdrawal compared with continuous dosing after successful treatment with baricitinib in patients with moderate-to-severe atopic dermatitis in a randomized substudy from the long-term extension study BREEZE-AD3. Br J Dermatol. 2023 Feb 10;188(2):208-217. doi: 10.1093/bjd/ljac057.
PubMed 36763879Wollenberg A, Kircik L, Simpson E, Brinker D, Katoh N, Rueda MJ, Issa M, Yang F, Feely M, Alexis A. Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials. Dermatitis. 2023 Jul-Aug;34(4):308-314. doi: 10.1089/derm.2022.0027. Epub 2023 Feb 6.
PubMed 36749121Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
PubMed 36255569Silverberg JI, Simpson EL, Wollenberg A, Bissonnette R, Kabashima K, DeLozier AM, Sun L, Cardillo T, Nunes FP, Reich K. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021 Jun 1;157(6):691-699. doi: 10.1001/jamadermatol.2021.1273.
PubMed 33978711King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
PubMed 33826132
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03334435
- Acronym / sponsor ID
- BREEZE-AD3 / 16587
- Conditions
- Atopic Dermatitis
- Keywords
- eczema, atopic eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,645 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Incyte Corporation
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 1 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.
Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Responders and Partial Responders (RPR)-Placebo | Placebo comparator | Drug: Baricitinib, Drug: PlaceboResponders or partial responders (RPR) [Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally. |
| RPR-Bari 1-milligram (mg) | Experimental | Drug: BaricitinibRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally. |
| RPR-Bari 2-mg | Experimental | Drug: BaricitinibRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally. |
| RPR-Bari 4-mg | Experimental | Drug: BaricitinibRPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally. |
| Non-responders (NR): Bari 1 mg to 2 mg | Experimental | Drug: BaricitinibNon-responder (NR) [those not meeting definition of RPR] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally. |
| NR: Bari 1 mg to 4 mg | Experimental | Drug: BaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally. |
| NR: Bari 2 mg to 2 mg | Experimental | Drug: BaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally. |
| NR: Bari 2 mg to 4 mg | Experimental | Drug: BaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally. |
| NR: Bari 4 mg to 4 mg | Experimental | Drug: BaricitinibNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally. |
| NR: Placebo to Bari 2 mg | Experimental | Drug: Baricitinib, Drug: PlaceboNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally. |
| NR: Placebo to Bari 4 mg | Experimental | Drug: Baricitinib, Drug: PlaceboNR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally. |
| Bari 1 mg | Experimental | Drug: BaricitinibParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally. |
| Bari 2 mg | Experimental | Drug: BaricitinibParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally. |
| Bari 4 mg | Experimental | Drug: BaricitinibParticipants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally. |
| Bari 2-mg Open-Label Addendum | Experimental | Drug: BaricitinibParticipants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
- Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
- Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
- Agree to use emollients daily.
Key exclusion criteria (22 listed)
- Had investigational product permanently discontinued at any time during a previous Baricitinib study.
- Had temporary investigational product interruption continue at the final study visit of a previous Baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study
- OR
- Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:
- Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: LY3009104Administered orally | Drug | Bari 1 mg, Bari 2 mg, Bari 2-mg Open-Label Addendum, Bari 4 mg, NR: Bari 1 mg to 4 mg, NR: Bari 2 mg to 2 mg, NR: Bari 2 mg to 4 mg, NR: Bari 4 mg to 4 mg, NR: Placebo to Bari 2 mg, NR: Placebo to Bari 4 mg, Non-responders (NR): Bari 1 mg to 2 mg, RPR-Bari 1-milligram (mg), RPR-Bari 2-mg, RPR-Bari 4-mg, Responders and Partial Responders (RPR)-Placebo |
| PlaceboAdministered orally | Drug | NR: Placebo to Bari 2 mg, NR: Placebo to Bari 4 mg, Placebo, Responders and Partial Responders (RPR)-Placebo |
Primary outcome
Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1
Time frame: Weeks 16, 36 and 52
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
Time frame: Weeks 16, 36, and 52
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
35 secondary outcomes
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
Time frame: Weeks 16, 36, and 52
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2
Time frame: Weeks 16, 36, and 52
Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
Time frame: Weeks 16, 36 and 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
Time frame: Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
Time frame: Weeks 16, 36, 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
Time frame: Weeks 16, 36, and 52
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75
Time frame: Weeks 16, 36, and 52 Weeks
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
Time frame: Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
Time frame: Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
Time frame: Weeks 16, 36, and 52
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS)
Time frame: Week 16
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
Time frame: Week 16
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
Time frame: Week 16
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
Time frame: Week 16
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
Time frame: Week 16
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
Time frame: Week 16
Percentage of Participants Who Achieved a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
Time frame: Weeks 68, 104
Percentage of Participants Who Achieved a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
Time frame: Weeks 68, 104
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
Time frame: Weeks 68, 104
Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study)
Time frame: Week 52 Up to Week 200
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
Time frame: Weeks 68, 104
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
Time frame: Weeks 68, 104
Percentage of Participants With a Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization(Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering Substudy With IGA 0 or 1)
Time frame: Weeks 68, 104
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
Time frame: Week 68
Percentage of Participants With a Response of IGA 0 or 1 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
Time frame: Week 68
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
Time frame: Week 68
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy)
Time frame: Week 104
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy)
Time frame: Week 104
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy)
Time frame: Week 104
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36912484Thyssen JP, Werfel T, Barbarot S, Hunter HJA, Pierce E, Sun L, Cirri L, Buchanan AS, Lu N, Wollenberg A. Maintained improvement in physician- and patient-reported outcomes with baricitinib in adults with moderate-to-severe atopic dermatitis who were treated for up to 104 weeks in a randomized trial. J Dermatolog Treat. 2023 Dec;34(1):2190430. doi: 10.1080/09546634.2023.2190430.
- Derived from this study: PubMed 36763879Reich K, Simpson E, Wollenberg A, Bissonnette R, Abe M, Cardillo T, Janes J, Sun L, Chen S, Silverberg JI. Efficacy of downtitration or treatment withdrawal compared with continuous dosing after successful treatment with baricitinib in patients with moderate-to-severe atopic dermatitis in a randomized substudy from the long-term extension study BREEZE-AD3. Br J Dermatol. 2023 Feb 10;188(2):208-217. doi: 10.1093/bjd/ljac057.
- Derived from this study: PubMed 36749121Wollenberg A, Kircik L, Simpson E, Brinker D, Katoh N, Rueda MJ, Issa M, Yang F, Feely M, Alexis A. Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials. Dermatitis. 2023 Jul-Aug;34(4):308-314. doi: 10.1089/derm.2022.0027. Epub 2023 Feb 6.
- Derived from this study: PubMed 36255569Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
- Derived from this study: PubMed 33978711Silverberg JI, Simpson EL, Wollenberg A, Bissonnette R, Kabashima K, DeLozier AM, Sun L, Cardillo T, Nunes FP, Reich K. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021 Jun 1;157(6):691-699. doi: 10.1001/jamadermatol.2021.1273.
- Derived from this study: PubMed 33826132King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
- A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis (Eczema) (BREEZE-AD3)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
185 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baricitinib in people with Atopic Dermatitis, run by Eli Lilly and Company at 185 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 185 sites in Japan, Germany, Poland, Spain, Czechia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 (time frame: Weeks 16, 36 and 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03334435, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.