AzTrials
AzTrials

Atopic DermatitisPhase 3Heads UpNCT03738397

A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

A Phase 3 study testing Upadacitinib and Dupilumab in people with Atopic Dermatitis, run by AbbVie at 159 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. Read more about this study

Who is it for?
Ages 18 to 76 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Upadacitinib and Dupilumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
673 participants
Where
159 sitesin 23 countries
Study dates
21 Feb 2019to 9 Dec 2020
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 to 76 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
  • Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.

Who cannot join

  • Participant has prior exposure to Janus Kinase (JAK) inhibitor.
  • Participant has prior exposure to dupilumab.
  • Participant is unable or unwilling to discontinue current AD treatments prior to the study.
  • Participant has requirement of prohibited medications during the study.
  • Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
  • Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Trial locations and contacts

159 sites in 23 countries.

159 sites in 23 countries

United States52 sites

  • Georgia Pollens Clinical Research Centers, Inc /ID# 211092

    Albany, Georgia, 31707-1282

  • Orion Clinical Research /ID# 208765

    Austin, Texas, 78759-4100

  • Clinical Research Center AL /ID# 210277

    Birmingham, Alabama, 35209-6802

  • DiscoveResearch, Inc. /ID# 213171

    Bryan, Texas, 77802

  • Medical University of South Carolina /ID# 211054

    Charleston, South Carolina, 29425

  • Northwestern University Feinberg School of Medicine /ID# 208680

    Chicago, Illinois, 60611-2927

  • Medical Dermatology Associates of Chicago /ID# 210265

    Chicago, Illinois, 60654-6903

  • Clarkston Skin Research /ID# 208739

    Clarkston, Michigan, 48346

  • Univ Hosp Cleveland /ID# 208852

    Cleveland, Ohio, 44106

  • The Ohio State University /ID# 209254

    Columbus, Ohio, 43210-1257

  • Henry Ford Health System /ID# 208741

    Detroit, Michigan, 48202

  • Epiphany Dermatology - Fort Worth /ID# 211187

    Fort Worth, Texas, 76244-6548

  • Tien Q Nguyen MD, Inc /ID# 208934

    Fountain Valley, California, 92708-3701

  • UCSF Fresno /ID# 213253

    Fresno, California, 93701-2302

  • The Community Research of South Florida /ID# 211145

    Hialeah, Florida, 33016-1897

  • Dawes Fretzin, LLC /ID# 209187

    Indianapolis, Indiana, 46256

  • Clinical Research Solutions, LLC /ID# 212542

    Jackson, Tennessee, 38305-2163

  • Sante Clinical Research /ID# 212970

    Kerrville, Texas, 78028-9640

  • Forest Hills Dermatology Group /ID# 209249

    Kew Gardens, New York, 11415

  • Dartmouth-Hitchcock Medical Center /ID# 213727

    Lebanon, New Hampshire, 03756

  • Allergy, Asthma & Immunology Associates, PC /ID# 213481

    Lincoln, Nebraska, 68505-2343

  • University of Arkansas for Medical Sciences /ID# 211688

    Little Rock, Arkansas, 72205

  • Jonathan Corren, MD. INC /ID# 208987

    Los Angeles, California, 90025-4749

  • California Allergy and Asthma Medical Group /ID# 213680

    Los Angeles, California, 90025-7014

  • Dermatology Research Associates /ID# 209097

    Los Angeles, California, 90045

  • Los Angelos Cataract Center /ID# 208524

    Los Angeles, California, 90056

  • Miami Dermatology and Laser Institute /ID# 212938

    Miami, Florida, 33173-3570

  • Florida International Rsrch cr /ID# 211562

    Miami, Florida, 33173

  • Clinical Research Institute, Inc /ID# 210852

    Minneapolis, Minnesota, 55402-2606

  • Dermatology Clinical Trials /ID# 214622

    Newport Beach, California, 92660-7853

  • Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058

    Normal, Illinois, 61761

  • Skin Specialists, PC /ID# 208843

    Omaha, Nebraska, 68144

  • Progressive Medical Research /ID# 211994

    Port Orange, Florida, 32127

  • Oregon Medical Res Center PC /ID# 208807

    Portland, Oregon, 97223

  • Oregon Health and Science University /ID# 208809

    Portland, Oregon, 97239

  • Beacon Clinical Research, LLC /ID# 209280

    Quincy, Massachusetts, 02169

  • Clinical Research Partners, LLC /ID# 212262

    Richmond, Virginia, 23220-4459

  • UC Davis Health /ID# 209285

    Sacramento, California, 95816

  • University of Utah /ID# 209001

    Salt Lake City, Utah, 84112-5500

  • Stephen Miller, MD PA /ID# 210071

    San Antonio, Texas, 78249

  • Ucsd /Id# 208990

    San Diego, California, 92103

  • Clinical Science Institute /ID# 211022

    Santa Monica, California, 90404-2102

  • Meridian Clinical Research Dermatology /ID# 213251

    Savannah, Georgia, 31406-2632

  • West Virginia Research Inst /ID# 212730

    South Charleston, West Virginia, 25309

  • Premier Clinical Research /ID# 212142

    Spokane, Washington, 99202

  • GCP Research /ID# 216020

    St. Petersburg, Florida, 33705

  • Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153

    Sugar Land, Texas, 77479-3153

  • Clinical Research Trials of Florida, Inc. /ID# 210751

    Tampa, Florida, 33607

  • Montefiore Medical Center /ID# 209647

    The Bronx, New York, 10467

  • Southside Dermatology /ID# 212004

    Tulsa, Oklahoma, 74132

  • Integrated Clinical Research LLC /ID# 208831

    West Palm Beach, Florida, 33406-6063

  • Wake Forest Univ HS /ID# 208892

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada10 sites

  • Kirk Barber Research, CA /ID# 209504

    Calgary, Alberta, T2G 1B1

  • Dermatology Research Institute Inc. /ID# 210942

    Calgary, Alberta, T2J 7E1

  • Dr. Wei Jing Loo Medicine Prof /ID# 211400

    London, Ontario, N6H 5L5

  • Lynderm Research Inc. /ID# 209505

    Markham, Ontario, L3P 1X2

  • DermEdge Research Inc. /ID# 211122

    Mississauga, Ontario, L5H 1G9

  • Dre Angelique Gagne-Henley M.D. inc. /ID# 209498

    Saint-Jérôme, Quebec, J7Z 7E2

  • Dr. Chih-ho Hong Medical Inc. /ID# 211032

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research /ID# 209503

    Surrey, British Columbia, V3V 0C6

  • Niakosari Medicine Professional Corporation /ID# 211401

    Toronto, Ontario, M2M 4J5

  • K. Papp Clinical Research /ID# 209509

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

France7 sites

  • CHRU Lille - Hopital Claude Huriez /ID# 209317

    Lille, Hauts-de-France, 59045

  • Hopital de la Timone /ID# 211245

    Marseille, 13385

  • CHU de Nantes - Hotel Dieu /ID# 208974

    Nantes, Pays de la Loire Region, 44093

  • Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 213374

    Nice, 06202

  • Polyclinique Courlancy /ID# 208975

    Reims, 51100

  • Charles Nicolle CHU Rouen /ID# 208973

    Rouen, Seine-Maritime, 76031

  • Hopital Larrey - CHU de Toulouse /ID# 208976

    Toulouse, 31059

Other trials in France

Italy7 sites

  • A.O. Policlinico Sant'Orsola Malpighi /ID# 209111

    Bologna, 40138

  • A.O.U. di Brescia /ID# 209115

    Brescia, 25123

  • Ospedale San Giovanni di Dio /ID# 209109

    Cagliari, 9124

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 210632

    Milan, Lombardy, 20122

  • AO Univ di Modena /ID# 209110

    Modena, 41100

  • Policlinico Univ Tor Vergata /ID# 209112

    Rome, 00133

  • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 215726

    Rozzano, Milano, 20089

Other trials in Italy

Germany6 sites

  • Gemeinschaftspraxis /ID# 211174

    Blankenfeld-mahlow, 15831

  • Hautklinik Klinikum Darmstadt /ID# 210938

    Darmstadt, 64283

  • Universitaetsklinikum Frankfurt /ID# 210934

    Frankfurt, 60590

  • Medizinische Hochschule Hannover /ID# 210939

    Hanover, 30625

  • TU Uniklinik Munchen /ID# 210937

    Munich, 80802

  • Universitatsklinikum Munster /ID# 210935

    Munster, Lower Saxony, 48149

Other trials in Germany

Malaysia6 sites

  • Hospital Pulau Pinang /ID# 210212

    George Town, 10450

  • Hospital Sultan Ismail /ID# 211037

    Johor Bahru, Johor, 81100

  • UKM Medical Centre /ID# 209178

    Kuala Lumpur, Selangor, 56000

  • University Malaya Med Ctr /ID# 208861

    Kuala Lumpur, 59100

  • Hospital Pakar Sultanah Fatimah /ID# 210185

    Muar town, Johor, 84000

  • Hospital Putrajaya /ID# 209177

    Putrajaya, 62250

Other trials in Malaysia

Netherlands6 sites

  • Centrum Oosterwal /ID# 209641

    Alkmaar, 1817 MS

  • Academisch Medisch Centrum /ID# 208578

    Amsterdam, North Holland, 1105 AZ

  • Bravis Ziekenhuis /ID# 208584

    Bergen op Zoom, North Brabant, 4624 VT

  • Universitair Medisch Centrum Groningen /ID# 208583

    Groningen, 9713 GZ

  • Erasmus Medisch Centrum /ID# 208582

    Rotterdam, 3015 GD

  • Universitair Medisch Centrum Utrecht /ID# 208579

    Utrecht, 3584 CX

Other trials in Netherlands

Poland6 sites

  • ClinicMed Daniluk, Nowak Sp.j. /ID# 211112

    Bialystok, Podlaskie Voivodeship, 15-879

  • Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy /ID# 211103

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094

  • Pratia MCM Krakow /ID# 207444

    Krakow, Lesser Poland Voivodeship, 30-510

  • Dermoklinika Medical Center /ID# 211026

    Lodz, Łódź Voivodeship, 90-436

  • Klinika Ambroziak Sp. z o.o. /ID# 207443

    Warsaw, Masovian Voivodeship, 02-758

  • Royalderm Agnieszka Nawrocka /ID# 211015

    Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

Spain6 sites

  • Hospital Universitario de Bellvitge /ID# 207063

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Dr. Negrin /ID# 208969

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Hospital de Manises /ID# 207062

    Manises, Valencia, 46940

  • Complejo Hospitalario Universitario de Pontevedra /ID# 207139

    Pontevedra, 36071

  • Hospital Universitario Arnau Vilanova /ID# 207065

    Valencia, 46015

  • Hospital Universitario y Politecnico La Fe /ID# 207064

    Valencia, 46026

Other trials in Spain

United Kingdom6 sites

  • Royal Alex Childrens County Hospital /ID# 209709

    Brighton, Brighton And Hove, BN2 5BE

  • Cardiff & Vale University Health Board /ID# 209745

    Cardiff, Wales, CF14 4XN

  • Royal Hospital for Children /ID# 210451

    Glasgow, Glasgow City, G51 4TF

  • Victoria Hospital /ID# 209853

    Kirkcaldy, Fife, KY2 5AH

  • The Royal Free Hospital /ID# 208659

    London, London, City of, NW3 2QG

  • Guy's and St Thomas' NHS Found /ID# 208881

    London, London, City of, SE1 9RT

Other trials in United Kingdom

Australia5 sites

  • Holdsworth House Medical Practice /ID# 214565

    Darlinghurst, New South Wales, 2010

  • The Skin Hospital /ID# 214401

    Darlinghurst, New South Wales, 2010

  • Sinclair Dermatology /ID# 209395

    East Melbourne, Victoria, 3002

  • Burswood Dermatology /ID# 214875

    Victoria Park, Western Australia, 6100

  • Veracity Clinical Research /ID# 211134

    Woolloongabba, Queensland, 4102

Other trials in Australia

Czechia5 sites

  • Fakultni Nemocnice Brno /ID# 212968

    Brno, 625 00

  • FN Hradec Kralove /ID# 209116

    Hradec Králové, 500 05

  • Nemocnice Jihlava, prispevkova organizace /ID# 209131

    Jihlava, 586 01

  • Fakultni nemocnice Ostrava /ID# 209117

    Ostrava, 708 52

  • Fakultni Nemocnice v Motole /ID# 209209

    Prague, 150 06

Other trials in Czechia

Hungary5 sites

  • Uno Medical Trials Kft /ID# 211177

    Budapest XIII, 1135

  • Debreceni Egyetem Klinikai Kozpont /ID# 210893

    Debrecen, 4032

  • Somogy Megyei Kaposi Mor Oktat /ID# 210149

    Kaposvár, 7400

  • Oroshazi Korhaz /ID# 210150

    Orosháza, Bekes County, 5900

  • Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 210892

    Pécs, 7624

Other trials in Hungary

Croatia4 sites

  • Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 209937

    Ivanić-Grad, Zagreb County, 10310

  • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 209935

    Zagreb, City of Zagreb, 10000

  • Djecja bolnica Srebrnjak /ID# 209939

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 209976

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Finland4 sites

  • Keski-pohjanmaa Central Hospital /ID# 209534

    Kokkola, Keski-Pohjanmaa, 67200

  • Mikkeli Central Hospital /ID# 210125

    Mikkeli, 50100

  • Oulu University Hospital /ID# 208961

    Oulu, North Ostrobothnia, 90220

  • Pihlajalinna Turku /ID# 209599

    Turku, 20100

Other trials in Finland

Israel4 sites

  • HaEmek Medical Center /ID# 210153

    Afula, 1834111

  • Rabin Medical Center /ID# 210012

    Petah Tikva, 4941492

  • Sheba Medical Center /ID# 210013

    Ramat Gan, 5239424

  • Ichilov Medical Center /ID# 210014

    Tel Aviv, 64239

Other trials in Israel

Taiwan4 sites

  • China Medical University Hosp /ID# 209770

    Taichung, Taichung, 40447

  • Chung Shan Medical University /ID# 208311

    Taichung, 40201

  • Taipei Municipal Wan Fang Hospital /ID# 209987

    Taipei, 116

  • National Taiwan University Hospital /ID# 208309

    Taipei City, Taipei, 100

Other trials in Taiwan

New Zealand3 sites

  • Optimal Clinical Trials Ltd /ID# 209475

    Auckland, 1010

  • Clinical Trials NZ /ID# 215590

    Hamilton, 3206

  • Wellington Hospital (Capital and Coast District Health Board) /ID# 215001

    Wellington, 6021

Other trials in New Zealand

Norway3 sites

  • Universitetssykehuset N-Norge, Harstad /ID# 209105

    Harstad, Troms, 9406

  • Universitetssykehuset N-Norge, Tromso /ID# 209103

    Tromsø, Troms, 9019

  • St. Olavs Hospital HF /ID# 209137

    Trondheim, Sor-Trondelag, 7006

Other trials in Norway

Singapore3 sites

  • National Skin Centre /ID# 208775

    Singapore, Central Singapore, 308205

  • National University Hospital /ID# 208774

    Singapore, 119074

  • Singapore General Hospital /ID# 208776

    Singapore, 169608

Other trials in Singapore

Ukraine3 sites

  • Kyiv City Clinical Skin and Venereal Hospital /ID# 210755

    Kyiv, 04209

  • ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210434

    Rivne, 33028

  • Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 210435

    Zaporizhzhya, Zaporizhzhia Oblast, 69063

Other trials in Ukraine

Ireland2 sites

  • St Vincent's University Hosp /ID# 208441

    Dublin, D04 T6F4

  • University Hospital Waterford /ID# 208442

    Waterford, X91 ER8E

Other trials in Ireland

Sweden2 sites

  • Skanes Universitetssjukhus /ID# 206783

    Malmö, Skåne County, 214 28

  • Karolinska University Hospital /ID# 207909

    Stockholm, SE-17176

Other trials in Sweden

About this study

Official title: A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis

This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Read the detailed description

The study is comprised of a 35-day screening period, a 24-week double-blinded treatment period, and a follow-up visit 12 weeks after the last dose. Participants who complete Week 24 have the option to enroll into an open-label study (Study M19-850; NCT04195698) of upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52 weeks.

Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either upadacitinib or dupilumab. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and age (<40, ≥ 40 to < 65, ≥ 65 years).

Being tested
Upadacitinib, Dupilumab, Placebo to dupilumab, Placebo to upadacitinib
Keywords
Upadacitinib, ABT-494, Dupilumab, Atopic Dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibBiological

    Also called ABT-494, RINVOQ®

    Extended release tablet

  • DupilumabBiological

    Also called Dupixent®

    Dupilumab is administered as a subcutaneous (SC) injection

  • Placebo to dupilumabDrug

    Placebo administered as a subcutaneous injection

  • Placebo to upadacitinibDrug

    Tablet

Study groups in NCT03738397
Study groupRoleWhat they receive
Upadacitinib 30 mg QDExperimentalParticipants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.
Receives: Biological: Upadacitinib; Drug: Placebo to dupilumab
Dupilumab 300 mg EOWExperimentalParticipants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.
Receives: Biological: Dupilumab; Drug: Placebo to upadacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    Measured: Baseline and Week 16

Secondary outcomes (7)

  1. Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 16

    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

    The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.

    Measured: Baseline (Week 0) to Week 16

  2. Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    Measured: Baseline and Week 16

  3. Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    Measured: Baseline and Week 16

  4. Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 4

    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

    The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.

    Measured: Baseline (Week 0) to Week 4

  5. Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2

    EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

    The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

    Measured: Baseline and Week 2

  6. Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 1

    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

    The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.

    Measured: Baseline (Week 0) to Week 1

  7. Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16

    The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

    Measured: Baseline and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2018
  2. Study start21 Feb 2019
  3. Primary completion27 Aug 2020
  4. Study completion9 Dec 2020

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03738397
Sponsor's protocol ID
M16-046
Other IDs
2018-002264-57, 2018
Acronym
Heads Up
Status last verified
Feb 2024
First submitted
9 Nov 2018
Last updated
15 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Expanded access
Available

Publications

  • Blauvelt A, Teixeira HD, Simpson EL, Costanzo A, De Bruin-Weller M, Barbarot S, Prajapati VH, Lio P, Hu X, Wu T, Liu J, Ladizinski B, Chu AD, Eyerich K. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2021 Sep 1;157(9):1047-1055. doi: 10.1001/jamadermatol.2021.3023.

    PubMed 34347860

  • Blauvelt A, Simpson EL, Eyerich K, de Bruin-Weller M, Barbarot S, Lio PA, Hurst W, Tcherny-Lessenot S, Levy S, Bastian M. Benefit-risk profile comparison between dupilumab and upadacitinib: a structured benefit-risk assessment of the Heads Up trial. J Dermatolog Treat. 2026 Dec;37(1):2675726. doi: 10.1080/09546634.2026.2675726. Epub 2026 Jun 1.

    PubMed 42223292

  • Simpson EL, Silverberg JI, Prajapati VH, Eyerich K, Katoh N, Boguniewicz M, Guttman-Yassky E, Song EJ, Lee WJ, Teixeira HD, Wu T, Sancho Sanchez C, Vigna N, Calimlim BM, de Bruin-Weller M. Rapid Itch Improvement and Skin Clearance with Upadacitinib Versus Placebo (Measure Up 1 and Measure Up 2) and Versus Dupilumab (Heads Up): Results from Three Phase 3 Clinical Trials in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Aug;15(8):2061-2076. doi: 10.1007/s13555-025-01443-w. Epub 2025 Jun 2.

    PubMed 40457140

  • Blauvelt A, Eyerich K, Irvine AD, de Bruin-Weller M, Kwatra SG, Gooderham M, Kim B, Calimlim BM, Lee WJ, Raymundo EM, Liu Y, Ofori S, Platt AM, Silverberg JI. More Time Spent with Clear Skin and No Itch with Upadacitinib versus Dupilumab for Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2621-2630. doi: 10.1007/s13555-024-01242-9. Epub 2024 Aug 7.

    PubMed 39110139

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib and Dupilumab in people with Atopic Dermatitis, run by AbbVie at 159 sites in 23 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 2 inclusion and 6 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 sites in United States, Canada, France, Italy, Germany and 18 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. 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 2 Feb 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?

Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16 (time frame: Baseline and Week 16). 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 NCT03738397, which also lists 4 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 15 Mar 2024.

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