Atopic DermatitisPhase 3ADjoinNCT04392154
Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)
A Phase 3 study testing Lebrikizumab in people with Atopic Dermatitis, run by Eli Lilly and Company at 321 sites in 16 countries.
Trial summary
This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lebrikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,153 participants
- Where
- 321 sitesin 16 countries
- Study dates
- 15 Jun 2020to 22 Apr 2025
- Phase
- Phase 3
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria for participants coming from a parent study:
Participants must meet all the following criteria to be eligible for this study:
- Received treatment in a lebrikizumab study, NCT04146363, NCT04178967, NCT04250337, NCT04250350 and have adequately completed the study treatments and last patient visit of the parent trial.
- For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.
Exclusion Criteria for participants coming from a parent study:
Participants meeting any of the criteria below will not be included in this study:
- Participants who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. *
- Participants who, during their participation in the parent trial, developed an AE that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. *
- Conditions in the previous parent study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to investigator - or sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.). *
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Open-Label Addendum Inclusion Criteria:
Participants must meet all the following criteria to be eligible for this study addendum:
- Male or female adults and adolescents (≥12 to <18 years of age and weighing ≥40 kilogram (kg).
- Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening.
- Eczema Area and Severity Index (EASI) score ≥16 at baseline.
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at baseline.
- ≥10% body surface area (BSA) of AD involvement at baseline.
- History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
Open-Label Addendum Exclusion Criteria:
Participants meeting any of the criteria below will be excluded from this study addendum:
- Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
- History of anaphylaxis
- Treatment with topical prescription moisturizers, corticosteroids, calcineurin inhibitors, or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to baseline.
- Treatment with any of the following agents within 4 weeks prior to the baseline.
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy and photochemotherapy (PUVA) for AD.
- Treatment with the following prior to baseline:
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy and photochemotherapy (PUVA) for AD.
- Treatment with the following prior to baseline:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- B Cell-depleting biologics, including rituximab, within 6 months.
- Other Biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
- Regular use (more than 2 uses per week) of a tanning booth/parlor within 4 weeks of baseline.
- Treatment with a live (attenuated) vaccine within 12 weeks of the baseline or planned during the study.
- Uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma, (as defined by the investigator).
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- Evidence of active acute or chronic hepatitis
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- History of malignancy, including mycosis fungoides, within 5 years before screening, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
Open-Label Extension Addendum Inclusion Criteria:
Have completed Week 100 of Study KGAA and have not yet completed the safety follow-up visit for the main study.
Open-Label Extension Addendum Exclusion Criteria:
Have initiated treatment with a medication prohibited by Study KGAA before addendum baseline. This includes use of biologics for AD (for example, dupilumab and tralokinumab) during the safety follow-up period of Study KGAA.
Trial locations and contacts
321 sites in 16 countries.
321 sites in 16 countries
United States160 sites
Georgia Pollens Clinical Research Centers, Inc
Albany, Georgia, 31707
Orange County Research Institute
Anaheim, California, 92801
Palmetto Clinical Trial Services, LLC
Anderson, South Carolina, 29621
Fivenson Dermatology
Ann Arbor, Michigan, 48103
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Arlington Research Center, Inc
Arlington, Texas, 76011
Oakland Dermatology
Auburn Hills, Michigan, 48326
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309
Meridian Clinical Research
Baton Rouge, Louisiana, 70808
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Bellaire Dermatology Associates
Bellaire, Texas, 77401
ActivMed Practices and Research
Beverly, Massachusetts, 01915
Wallace Medical Group, Inc.
Beverly Hills, California, 90211
Clinical Research Center of Alabama- Birmingham
Birmingham, Alabama, 35244
Tufts Medical Center
Boston, Massachusetts, 02111
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015
Hope Clinical Research, Inc.
Canoga Park, California, 91303
IMMUNOe International Research Centers
Centennial, Colorado, 80112
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Medical University of South Carolina
Charleston, South Carolina, 29425
OnSite Clinical Solutions
Charlotte, North Carolina, 28277
Northwestern University
Chicago, Illinois, 60611
Michigan Center for Research Company
Clarkston, Michigan, 48346
St. Francis Medical Institute
Clearwater, Florida, 33765
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907-6231
IACT Health - VHC
Columbus, Georgia, 31904
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
Pediatric Skin Research, LLC
Coral Gables, Florida, 33146
Central Connecticut Dermatology
Cromwell, Connecticut, 06416
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Modern Research Associates
Dallas, Texas, 75231
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Henry Ford Hospital
Detroit, Michigan, 48202
Austin Institute for Clinical Research
Dripping Springs, Texas, 78620
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341
Clinical Physiology Associates
Fort Myers, Florida, 33912
Johnson Dermatology
Fort Smith, Arkansas, 72916
Innovate Research, LLC
Fort Worth, Texas, 76244
First OC Dermatology
Fountain Valley, California, 92708
MD Studies
Fountain Valley, California, 92708
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
Associated Skin Care Specialists
Fridley, Minnesota, 55432
The University of Florida Health System
Gainesville, Florida, 32606
Rivergate Dermatology Clinical Research Center PL
Goodlettsville, Tennessee, 37072
Medication Management
Greensboro, North Carolina, 27408
Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
Hackensack, New Jersey, 07601
Direct Helpers Research Center
Hialeah, Florida, 33012
The Community Research of South Florida
Hialeah, Florida, 33016
Encore Medical Research
Hollywood, Florida, 33021
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Center for Clinical Studies
Houston, Texas, 77004
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
Encore Imaging & Medical Research
Houston, Texas, 77065
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Axon Clinical Research
Inglewood, California, 90301
Solutions Through Advanced Research
Jacksonville, Florida, 32256
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Forest Hills Dermatology Group
Kew Gardens, New York, 11415
Sunwise Clinical Research
Lafayette, California, 94549
Avance Clinical Trials Inc
Laguna Niguel, California, 92677
Cutis Wellness Dermatology
Laredo, Texas, 78041
Laredo Dermatology Associates P.A.
Laredo, Texas, 78041
JDR Dermatology Research
Las Vegas, Nevada, 89148
California Allergy and Asthma Medical Group + Research Center
Los Angeles, California, 90025
Keck School of Medicine University of Southern California
Los Angeles, California, 90033
Dermatology Research Associates
Los Angeles, California, 90045
LA Universal Research Center, INC
Los Angeles, California, 90057
Skin Sciences, PLLC
Louisville, Kentucky, 40217
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
GSI Clinical Research, LLC
Margate, Florida, 33063
Marietta Dermatology Clinical Research
Marietta, Georgia, 30060
Crisor, LLC, Medford office
Medford, Oregon, 97504
Vitae Research Center, LLC
Miami, Florida, 33135
Acevedo Clinical Research Associates
Miami, Florida, 33142
International Dermatology Research, Inc.
Miami, Florida, 33144
Community Research Foundation Inc
Miami, Florida, 33145
Sanchez Clinical Research Inc
Miami, Florida, 33157
Miami Dermatology and Laser Research
Miami, Florida, 33173
Well Pharma Medical Research Corp.
Miami, Florida, 33173
Florida Research Center, Inc
Miami, Florida, 33174
C & R Research Services USA
Miami Beach, Florida, 33169
Wellness Clinical Research
Miami Lakes, Florida, 33016
University of Utah MidValley Dematology
Murray, Utah, 84107
Associated Skin Care Specialists
New Brighton, Minnesota, 55112
Tulane Univ School of Med
New Orleans, Louisiana, 70112
JUVA Skin & Laser Center
New York, New York, 10022-3350
Icahn Sch of Med at Mt. Sinai
New York, New York, 10029
Sadick Research Group
New York, New York, 10075
Dermatology Clinical Trials
Newport Beach, California, 92660
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Sneeze, Wheeze, & Itch Associates LLC
Normal, Illinois, 61761
Arkansas Research Trials
North Little Rock, Arkansas, 72117
Tory Sullivan, MD PA
North Miami Beach, Florida, 33162
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
Advanced Dermatology of the Midlands
Omaha, Nebraska, 68144
Park Avenue Dermatology
Orange Park, Florida, 32073
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, 66210
Cura Clinical Research
Palmdale, California, 93551
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, 33028
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Paddington Testing Company Inc
Philadelphia, Pennsylvania, 19103
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Oregon Medical Research Center
Portland, Oregon, 97201
Oregon Dermatology and Research Center
Portland, Oregon, 97210
OHSU Center for Health and Healing
Portland, Oregon, 97239
ALLCUTIS Research
Portsmouth, New Hampshire, 03801
MD Strategies Research Centers MDSRC
Poway, California, 92064
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169
Wake Research Associates
Raleigh, North Carolina, 27612
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, 20850
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
Arlington Dermatology
Rolling Meadows, Illinois, 60008
Integrative Skin Science and Research
Sacramento, California, 95815
Integrative Skin Science and Research
Sacramento, California, 95825
St Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, 49085
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Velocity Clinical Research - Woseth Dermatology
Salt Lake City, Utah, 84117
Progressive Clinical Research
San Antonio, Texas, 78213
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Therapeutics Clinical Research
San Diego, California, 92123
University Clinical Trials
San Diego, California, 92123
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
San Diego, California, 92123
Synergy Dermatology
San Francisco, California, 94132
Care Access Research
San Jose, California, 95117
San Luis Dermatology & Laser Clinic
San Luis Obispo, California, 93405
Advanced Medical Research
Sandy Springs, Georgia, 30328
Southern California Dermatology, Inc.
Santa Ana, California, 92701
Georgia Skin & Cancer Clinic
Savannah, Georgia, 31419
Investigate MD
Scottsdale, Arizona, 85255
Dermatology Associates of Seattle
Seattle, Washington, 98101
Kansas Medical Clinic, an Elligo Health Research, Inc.
Shawnee Mission, Kansas, 66216
Northshore University Healthsystem
Skokie, Illinois, 60077
Premier Clinical Research
Spokane, Washington, 99202
Central Dermatology PC
St Louis, Missouri, 63117
Acclaim Dermatology PLLC
Sugar Land, Texas, 77479
DermDox Dermatology Centers
Sugarloaf, Pennsylvania, 18249
ForCare Clinical Research
Tampa, Florida, 33613-1244
Olympian Clinical Research
Tampa, Florida, 33614
University of South Florida College of Medicine
Tampa, Florida, 33620
Montefiore Medical Center
The Bronx, New York, 10467-2490
Kansas Medical Clinic
Topeka, Kansas, 66614
Central States Research
Tulsa, Oklahoma, 74136
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
Peak Research LLC
Upper Saint Clair, Pennsylvania, 15241
AAPRI Clinical Research Institute
Warwick, Rhode Island, 02886
Medical Faculty Associates, Inc.
Washington D.C., District of Columbia, 20016
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Advanced Asthma and Allergy
Watertown, New York, 13601
Center for Clinical Studies
Webster, Texas, 77598
Dundee Dermatology
West Dundee, Illinois, 60118
Jordan Valley Dermatology Center
West Jordan, Utah, 84088
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
Poland28 sites
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
Bialystok, 15-369
Wojewodzki Szpital Zespolony
Elblag, 82-300
Clinica Vitae Sp. z o.o.
Gdansk, Woj. Pomorskie, 80-344
Oddzial Dermatologii COPERNICUS
Gdansk, 80-462
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdynia, 81-553
Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611
Holsamed
Katowice, 40-600
Holsamed
Katowice, 40-851
Gabinet Dermatlogiczny. Beata Krecisz
Kielce, 25-155
Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
Krakow, Lesser Poland Voivodeship, 30-033
Diamond Clinic
Krakow, Lesser Poland Voivodeship, 31-559
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Lodz, Łódź Voivodeship, 90-436
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin, 20-081
Labderm s.c.
Ossy, Silesian Voivodeship, 42-624
Centrum Alergologii Teresa Hofman
Poznan, 60-214
Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii
Rzeszów, 35-055
Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
Szczecin, West Pomeranian Voivodeship, 70-332
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71 500
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Tarnów, 33-100
Centralny Szpital Kliniczny MSWiA
Warsaw, Masovian Voivodeship, 02-507
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, 02-625
Clinical Research Group Sp. z o.o.
Warsaw, 01-142
High-Med Prywatny Gabinet Lekarski
Warsaw, 01-817
MTZ Clinical Research Sp.z.o.o.
Warsaw, 02-106
Klinika Ambroziak Sp. Z.O.O.
Warsaw, 02-953
dermMedica Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, 51-503
CityClinic Przychodnia Lekarsko-Psychologiczna
Wroclaw, 50-566
Germany23 sites
Dermazentrum Augsburg
Augsburg, Bavaria, 86179
Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
Augsburg, 86150
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455
Charité Campus Virchow-Klinikum
Berlin, 10117
ISA GmbH
Berlin, 10789
Praxis für Ganzheitliche Dermatologie im Ärztehaus
Berlin, 13055
Hautzentrum im Jahrhunderthaus
Bochum, North Rhine-Westphalia, 44793
Elbe Klinikum Buxtehude
Buxtehude, Lower Saxony, 21614
Rosenpark Research GmbH
Darmstadt, Hesse, 64283
Hautarztpraxis Dr. Gerlach
Dresden, Saxony, 01097
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
Dresden, Saxony, 01307
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60596
SRH Wald-Klinikum Gera
Gera, Thuringia, 07548
Dermatologikum Hamburg
Hamburg, 20144
TFS Trial Support Form GmbH
Hamburg, 20537
Studienzentrum Dr.Beate Schwarz
Langenau, Baden-Wurttemberg, 89129
Universität Leipzig - Universitätsklinikum
Leipzig, Saxony, 04103
Velocity Clinical Research Leipzig GmbH
Leipzig, Saxony, 04103
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, 48149
Klinische Forschung Osnabrück
Osnabrück, Lower Saxony, 49074
Company for Medical Study & Service Selters GmbH
Selters, Rhineland-Palatinate, 56242
Hautarztpraxis am Löwenmarkt
Stuttgart, Baden-Wurttemberg, 70499
Canada20 sites
CCA Medical Research
Ajax, Ontario, L1S7K8
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
Skin Health
Cobourg, Ontario, K9A 0Z4
Lynderm Research Inc.
Markham, Ontario, L3P 1X3
International Dermatology Research
Montreal, Quebec, H3H1V4
International Dermatology Research
Montreal, Quebec, H4A 3J1
North York Research Inc.
North York, Ontario, M2M4J5
The Centre for Clinical Trials, Inc
Oakville, Ontario, L6J7W5
Ottawa Allergy Research Corp
Ottawa, Ontario, K1G 6C6
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2
Skin Health
Peterborough, Ontario, K9J 5K2
CARe Clinic
Red Deer, Alberta, T4P1K4
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
AvantDerm
Toronto, Ontario, M5A3R6
University of British Columbia
Vancouver, British Columbia, V5Z 4E8
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
Australia19 sites
The Skin Centre
Benowa, Queensland, 4217
Emeritus Research
Camberwell, Victoria, 3124
Skin Health Institute Inc.
Carlton, Victoria, 3053
The Skin Hospital
Darlinghurst, New South Wales, 02010
Fremantle Dermatology
Fremantle, Western Australia, 6160
Clinical Trials SA Pty Ltd
Hectorville, South Australia, 5073
Premier Specialists Pty Ltd
Kogarah, New South Wales, 2217
The St. George Hospital
Kogarah, New South Wales, 2217
Sinclair Dermatology
Melbourne, Victoria, 3002
Captain Stirling Medical Centre
Nedlands, 6009
The Royal Melbourne Hospital
Parkville, Victoria, 03050
Royal Children's Hospital
Parkville, Victoria, 3052
Woden Dermatology
Phillip, Australian Capital Territory, 2606
University of the Sunshine Coast Clinical Trial Centre
Sippy Downs, Queensland, 04556
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Burswood Dermatology
Victoria Park, Western Australia, 06100
Skin & Cancer Foundation Australia
Westmead, New South Wales, 2045
Westmead Hospital
Westmead, New South Wales, 2145
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102
South Korea11 sites
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584
Pusan National University Hospital
Busan, Korea, 49241
Korea University Ansan Hospital
Gyeonggi-do, 15355
Incheon St. Mary's Hospital
Incheon, 21431
Hanyang University Medical Center
Seoul, Korea, 04763
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 07441
Severance Hospital, Yonsei University Health System
Seoul, 03722
Konkuk University Medical Center
Seoul, 05030
Chung-Ang University Hospital
Seoul, 06973
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
France9 sites
CHU de Bordeaux Hop St ANDRE
Bordeaux, Gironde, 33075
CHRU de Brest - Hôpital Morvan
Brest, 29200
CHU Dijonon
Dijon, 21079
CHD Vendee
La Roche-sur-Yon, 85000
Cabinet Médical
Martigues, 13500
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, 44093
CHU de Nice Hopital de L'Archet
Nice, 06202
Hopital Saint Louis
Paris, 75010
Hopital Larrey
Toulouse, 31059
Spain8 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Germans Trias i Pujol
Badalona, Catalunya [Cataluña], 08916
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario Basurto
Bilbao (Bizkaia), 48013
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], 8950
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Universitario Virgen Macarena
Seville, 41009
Lithuania7 sites
JSC "CD8 Alergology Clinic"
Kaunas, LT-44192
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, LT-50161
Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos
Vilnius, 08406
Jsc Renmeda
Vilnius, LT-07195
JSC "Center for Diagnosis and Treatment of Allergic Diseases"
Vilnius, LT-08109
JSC Inlita (Santaros CTC)
Vilnius, LT-08406
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08441
Taiwan7 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
Kaohsiung Chang Gung Memorial Hospital
Niaosong, Kaohsiung City, 833
Chung Shan Medical University Hospital
Taichung, 402
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei, 10002
Chang Gung Memorial Hospital - Linkou
Taoyuan City, 33305
Bulgaria6 sites
DCC Sveti Georgi
Haskovo, 6300
Diagnostic and Consultation Center 14
Sofia, 1408
Alexandrovska University Hospital
Sofia, 1431
Euro Derma clinic
Sofia, 1606
Military Medical Academy
Sofia, 1606
Medical centre Alitera-Med EOOD
Sofia, 1618
Mexico6 sites
Derma Norte del Bajio
Aguascalientes, 20130
Grupo Clinico CATEI Sociedad Civil
Guadalajara, Jalisco, 44657
Cemdeicy S.C.P.
Mérida, Yucatán, 97130
Hospital Infantil de Mexico Federico Gomez
Mexico City, Federal District, 06720
Clinica De Enfermedades Cronicas y Procedimientos Especiales
Morelia, Michoacán, 58249
Arke Estudios Clinicos S.A. de C.V.
Veracruz, 91910
Latvia5 sites
Clinic of Dermatology and STD
Riga, LV-1001
Health and Aesthetics LTD
Riga, LV-1009
Latvian Dermatology Institute
Riga, LV-1011
Health Center 4, Affiliate Diagnostic Center
Riga, LV1003
Smite Aija - Doctor Practice in Dermatology Venereology
Talsi, LV-3201
Ukraine5 sites
Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2
Kharkiv, 61038
SE "Institute of Dermatology and Venerology of NAMS of Ukraine"
Kharkiv, 61057
Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council
Poshtova Square 2, Zaporizhzhya, 69063
Rivne Regional Dermatology and Venereology Dispensary
Rivne, 33028
Treatment-diagnostic center PE "Asclepius"
Uzhhorod, 88000
Singapore4 sites
National University Hospital
Singapore, Central Singapore, 119074
Singapore General Hospital
Singapore, 169078
Kk Women'S and Childrens Hospital
Singapore, 229899
National Skin Centre NSC
Singapore, 308205
Estonia3 sites
Vahlberg & Pild OU
Talinn, 10134
Kliiniliste uuringute Keskus OU
Tartu, 50160
Tartu University Hospital
Tartu, 51417
About this study
Official title: A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)
This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months.
Read the detailed description
Participants who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study (parent study), DRM06-AD04 (NCT04146363), DRM06-AD05 (NCT04178967), DRM06-AD06 (NCT04250337), DRM06-AD17 (NCT04250350) or DRM06- AD18 (NCT04626297), will be offered the opportunity to enroll in this study. Participants may either be blinded or not blinded, depending on their parent study assignment.
This study will also be open to an additional approximately 100 participants in the United States (addendum) who have not completed participation in a Dermira- or Lilly-sponsored lebrikizumab study. Treatment will not be blinded.
This study will also include an Addendum to extend the study treatment period by an additional 32 weeks and to add a treatment arm testing dosing every 8 weeks. This Addendum will apply to existing study participants in selected countries. Treatment will not be blinded.
- Conditions
- Atopic Dermatitis
- Being tested
- Lebrikizumab
- Keywords
- Eczema, Dermatitis, Dermatitis, Atopic, Skin Diseases
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabBiological
Also called LY3650150, DRM06
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab Q2W (Primary Treatment Period) | Experimental | 250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks. Receives: Biological: Lebrikizumab |
| Lebrikizumab Q4W (Primary Treatment Period) | Experimental | 250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks. Receives: Biological: Lebrikizumab |
| Open-Label Extension Addendum: Lebrikizumab Q4W | Experimental | 250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks. Receives: Biological: Lebrikizumab |
| Open-Label Extension Addendum: Lebrikizumab Q8W | Experimental | 250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks. Receives: Biological: Lebrikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events
Percentage of participants discontinued from study treatment due to adverse events is reported.
Measured: Baseline to Week 100
Secondary outcomes (2)
Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100
The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point.
Measured: Week 100
Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin 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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity.
Measured: Week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start15 Jun 2020
- Primary completion19 Jul 2024
- Study completion22 Apr 2025
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 (3)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermira, Inc.
- 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
- NCT04392154
- Sponsor's protocol ID
- 17789
- Other IDs
- 2020-001211-24, J2T-DM-KGAA, DRM06-AD07
- Acronym
- ADjoin
- Status last verified
- Oct 2025
- First submitted
- 13 May 2020
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Guttman-Yassky E, Irvine AD, Gooderham M, Weidinger S, Spelman L, Silverberg JI, Crane H, ElMaraghy H, DeLuca-Carter L, Piruzeli MLB, Martimianaki G, Pierce E, Agell H, Thaci D. Three-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin). Dermatol Ther (Heidelb). 2026 Jun 19. doi: 10.1007/s13555-026-01810-1. Online ahead of print.
PubMed 42315763Silverberg JI, Wollenberg A, Stein Gold L, Yosipovitch G, Lio P, Vestergaard C, Stander S, Carrascosa JM, Gallo G, Casillas M, Ding Y, Yang FE, Pierce E, Agell H, Del Rosso J. Lebrikizumab provides stable skin response with no or minimal fluctuations for up to 2 years in patients with atopic dermatitis. Clin Exp Dermatol. 2026 May 26;51(6):1012-1019. doi: 10.1093/ced/llaf490.
PubMed 41206702Guttman-Yassky E, Weidinger S, Simpson EL, Gooderham M, Irvine AD, Spelman L, Silverberg JI, ElMaraghy H, DeLuca-Carter L, Piruzeli MLB, Hu C, Yang FE, Pierce E, Bardolet L, Thaci D. Two-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin). Dermatol Ther (Heidelb). 2025 Aug;15(8):2217-2232. doi: 10.1007/s13555-025-01452-9. Epub 2025 Jun 23.
PubMed 40549127