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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: Upadacitinib; Drug: Placebo to dupilumab; Biological: Dupilumab; Drug: Placebo to upadacitinib

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).

• Study Type: Interventional
• Enrollment (Actual): 673
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice /ID# 214565
    • Darlinghurst, New South Wales, Australia, 2010
      • The Skin Hospital /ID# 214401
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research /ID# 211134
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology /ID# 209395
  • Western Australia
    • Victoria Park, Western Australia, Australia, 6100
      • Burswood Dermatology /ID# 214875
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Kirk Barber Research, CA /ID# 209504
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc. /ID# 210942
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc. /ID# 211032
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical Research /ID# 209503
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Dr. Wei Jing Loo Medicine Prof /ID# 211400
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc. /ID# 209505
    • Mississauga, Ontario, Canada, L5H 1G9
      • DermEdge Research Inc. /ID# 211122
    • Toronto, Ontario, Canada, M2M 4J5
      • Niakosari Medicine Professional Corporation /ID# 211401
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research /ID# 209509
  • Quebec
    • Saint-Jerome, Quebec, Canada, J7Z 7E2
      • Dre Angelique Gagne-Henley M.D. inc. /ID# 209498
• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 209935
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Djecja bolnica Srebrnjak /ID# 209939
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Zagreb /ID# 209976
  • Zagrebacka Zupanija
    • Ivanic-Grad, Zagrebacka Zupanija, Croatia, 10310
      • Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 209937
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni Nemocnice Brno /ID# 212968
  • Hradec Kralove, Czechia, 500 05
    • FN Hradec Kralove /ID# 209116
  • Jihlava, Czechia, 586 01
    • Nemocnice Jihlava, prispevkova organizace /ID# 209131
  • Ostrava, Czechia, 708 52
    • Fakultni nemocnice Ostrava /ID# 209117
  • Praha, Czechia, 150 06
    • Fakultni Nemocnice v Motole /ID# 209209
• Finland
  • Mikkeli, Finland, 50100
    • Mikkeli Central Hospital /ID# 210125
  • Turku, Finland, 20100
    • Pihlajalinna Turku /ID# 209599
  • Keski-Pohjanmaa
    • Kokkola, Keski-Pohjanmaa, Finland, 67200
      • Keski-pohjanmaa Central Hospital /ID# 209534
  • Pohjois-Pohjanmaa
    • Oulu, Pohjois-Pohjanmaa, Finland, 90220
      • Oulu University Hospital /ID# 208961
• France
  • Marseille, France, 13385
    • Hopital de la Timone /ID# 211245
  • Nice, France, 06202
    • Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 213374
  • Reims, France, 51100
    • Polyclinique Courlancy /ID# 208975
  • Toulouse, France, 31059
    • Hopital Larrey - CHU de Toulouse /ID# 208976
  • Hauts-de-France
    • Lille CEDEX, Hauts-de-France, France, 59045
      • CHRU Lille - Hopital Claude Huriez /ID# 209317
  • Pays-de-la-Loire
    • Nantes CEDEX 1, Pays-de-la-Loire, France, 44093
      • CHU de Nantes - Hotel Dieu /ID# 208974
  • Seine-Maritime
    • Rouen CEDEX, Seine-Maritime, France, 76031
      • Charles Nicolle CHU Rouen /ID# 208973
• Germany
  • Blankenfeld-mahlow, Germany, 15831
    • Gemeinschaftspraxis /ID# 211174
  • Darmstadt, Germany, 64283
    • Hautklinik Klinikum Darmstadt /ID# 210938
  • Frankfurt, Germany, 60590
    • Universitaetsklinikum Frankfurt /ID# 210934
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover /ID# 210939
  • Munich, Germany, 80802
    • TU Uniklinik Munchen /ID# 210937
  • Niedersachsen
    • Munster, Niedersachsen, Germany, 48149
      • Universitatsklinikum Munster /ID# 210935
• Hungary
  • Budapest XIII, Hungary, 1135
    • Uno Medical Trials Kft /ID# 211177
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont /ID# 210893
  • Kaposvar, Hungary, 7400
    • Somogy Megyei Kaposi Mor Oktat /ID# 210149
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 210892
  • Bekes
    • Oroshaza, Bekes, Hungary, 5900
      • Oroshazi Korhaz /ID# 210150
• Ireland
  • Dublin, Ireland, D04 T6F4
    • St Vincent's University Hosp /ID# 208441
  • Waterford, Ireland, X91 ER8E
    • University Hospital Waterford /ID# 208442
• Israel
  • Afula, Israel, 1834111
    • HaEmek Medical Center /ID# 210153
  • Petakh Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 210012
  • Ramat Gan, Israel, 5239424
    • Sheba Medical Center /ID# 210013
  • Tel Aviv, Israel, 64239
    • Ichilov Medical Center /ID# 210014
• Italy
  • Bologna, Italy, 40138
    • A.O. Policlinico Sant'Orsola Malpighi /ID# 209111
  • Brescia, Italy, 25123
    • A.O.U. di Brescia /ID# 209115
  • Cagliari, Italy, 9124
    • Ospedale San Giovanni di Dio /ID# 209109
  • Modena, Italy, 41100
    • AO Univ di Modena /ID# 209110
  • Rome, Italy, 00133
    • Policlinico Univ Tor Vergata /ID# 209112
  • Lombardia
    • Milan, Lombardia, Italy, 20122
      • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 210632
  • Milano
    • Rozzano, Milano, Italy, 20089
      • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 215726
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Med Ctr /ID# 208861
  • Penang, Malaysia, 10450
    • Hospital Pulau Pinang /ID# 210212
  • Putrajaya, Malaysia, 62250
    • Hospital Putrajaya /ID# 209177
  • Johor
    • Johor Bahru, Johor, Malaysia, 81100
      • Hospital Sultan Ismail /ID# 211037
    • Muar, Johor, Malaysia, 84000
      • Hospital Pakar Sultanah Fatimah /ID# 210185
  • Selangor
    • Kuala Lumpur, Selangor, Malaysia, 56000
      • UKM Medical Centre /ID# 209178
• Netherlands
  • Alkmaar, Netherlands, 1817 MS
    • Centrum Oosterwal /ID# 209641
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen /ID# 208583
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medisch Centrum /ID# 208582
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht /ID# 208579
  • Noord-Brabant
    • Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
      • Bravis Ziekenhuis /ID# 208584
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Academisch Medisch Centrum /ID# 208578
• New Zealand
  • Auckland, New Zealand, 1010
    • Optimal Clinical Trials Ltd /ID# 209475
  • Hamilton, New Zealand, 3206
    • Clinical Trials NZ /ID# 215590
  • Wellington, New Zealand, 6021
    • Wellington Hospital (Capital and Coast District Health Board) /ID# 215001
• Norway
  • Sor-Trondelag
    • Trondheim, Sor-Trondelag, Norway, 7006
      • St. Olavs Hospital HF /ID# 209137
  • Troms
    • Harstad, Troms, Norway, 9406
      • Universitetssykehuset N-Norge, Harstad /ID# 209105
    • Tromso, Troms, Norway, 9019
      • Universitetssykehuset N-Norge, Tromso /ID# 209103
• Poland
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-094
      • Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy /ID# 211103
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-436
      • Dermoklinika Medical Center /ID# 211026
  • Malopolskie
    • Krakow, Malopolskie, Poland, 30-510
      • Pratia MCM Krakow /ID# 207444
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-758
      • Klinika Ambroziak Sp. z o.o. /ID# 207443
    • Warszawa, Mazowieckie, Poland, 02-962
      • Royalderm Agnieszka Nawrocka /ID# 211015
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-879
      • ClinicMed Daniluk, Nowak Sp.j. /ID# 211112
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital /ID# 208774
  • Singapore, Singapore, 169608
    • Singapore General Hospital /ID# 208776
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 308205
      • National Skin Centre /ID# 208775
• Spain
  • Pontevedra, Spain, 36071
    • Complejo Hospitalario Universitario de Pontevedra /ID# 207139
  • Valencia, Spain, 46015
    • Hospital Universitario Arnau Vilanova /ID# 207065
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 207064
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge /ID# 207063
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Hospital Universitario Dr. Negrin /ID# 208969
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Hospital de Manises /ID# 207062
• Sweden
  • Stockholm, Sweden, SE-17176
    • Karolinska University Hospital /ID# 207909
  • Skane Lan
    • Malmö, Skane Lan, Sweden, 214 28
      • Skanes Universitetssjukhus /ID# 206783
• Taiwan
  • Taichung City, Taiwan, 40201
    • Chung Shan Medical University /ID# 208311
  • Taipei, Taiwan, 116
    • Taipei Municipal Wan Fang Hospital /ID# 209987
  • Taichung
    • Taichung City, Taichung, Taiwan, 40447
      • China Medical University Hosp /ID# 209770
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 208309
• Ukraine
  • Kyiv, Ukraine, 04209
    • Kyiv City Clinical Skin and Venereal Hospital /ID# 210755
  • Rivne, Ukraine, 33028
    • ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210434
  • Zaporizka Oblast
    • Zaporizhzhya, Zaporizka Oblast, Ukraine, 69063
      • Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 210435
• United Kingdom
  • Brighton And Hove
    • Brighton, Brighton And Hove, United Kingdom, BN2 5BE
      • Royal Alex Childrens County Hospital /ID# 209709
  • Fife
    • Kirkcaldy, Fife, United Kingdom, KY2 5AH
      • Victoria Hospital /ID# 209853
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G51 4TF
      • Royal Hospital for Children /ID# 210451
  • London, City Of
    • London, London, City Of, United Kingdom, NW3 2QG
      • The Royal Free Hospital /ID# 208659
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guy's and St Thomas' NHS Found /ID# 208881
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XN
      • Cardiff & Vale University Health Board /ID# 209745
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209-6802
      • Clinical Research Center AL /ID# 210277
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences /ID# 211688
  • California
    • Fountain Valley, California, United States, 92708-3701
      • Tien Q Nguyen MD, Inc /ID# 208934
    • Fresno, California, United States, 93701-2302
      • UCSF Fresno /ID# 213253
    • Los Angeles, California, United States, 90025-4749
      • Jonathan Corren, MD. INC /ID# 208987
    • Los Angeles, California, United States, 90025-7014
      • California Allergy and Asthma Medical Group /ID# 213680
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates /ID# 209097
    • Los Angeles, California, United States, 90056
      • Los Angelos Cataract Center /ID# 208524
    • Newport Beach, California, United States, 92660-7853
      • Dermatology Clinical Trials /ID# 214622
    • Sacramento, California, United States, 95816
      • UC Davis Health /ID# 209285
    • San Diego, California, United States, 92103
      • Ucsd /Id# 208990
    • Santa Monica, California, United States, 90404-2102
      • Clinical Science Institute /ID# 211022
  • Florida
    • Hialeah, Florida, United States, 33016-1897
      • The Community Research of South Florida /ID# 211145
    • Miami, Florida, United States, 33173-3570
      • Miami Dermatology and Laser Institute /ID# 212938
    • Miami, Florida, United States, 33173
      • Florida International Rsrch cr /ID# 211562
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research /ID# 211994
    • Saint Petersburg, Florida, United States, 33705
      • GCP Research /ID# 216020
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida, Inc. /ID# 210751
    • West Palm Beach, Florida, United States, 33406-6063
      • Integrated Clinical Research LLC /ID# 208831
  • Georgia
    • Albany, Georgia, United States, 31707-1282
      • Georgia Pollens Clinical Research Centers, Inc /ID# 211092
    • Savannah, Georgia, United States, 31406-2632
      • Meridian Clinical Research Dermatology /ID# 213251
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 208680
    • Chicago, Illinois, United States, 60654-6903
      • Medical Dermatology Associates of Chicago /ID# 210265
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin, LLC /ID# 209187
  • Massachusetts
    • Quincy, Massachusetts, United States, 02169
      • Beacon Clinical Research, LLC /ID# 209280
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Clarkston Skin Research /ID# 208739
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 208741
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402-2606
      • Clinical Research Institute, Inc /ID# 210852
  • Nebraska
    • Lincoln, Nebraska, United States, 68505-2343
      • Allergy, Asthma & Immunology Associates, PC /ID# 213481
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC /ID# 208843
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center /ID# 213727
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center /ID# 209647
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group /ID# 209249
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Univ HS /ID# 208892
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Univ Hosp Cleveland /ID# 208852
    • Columbus, Ohio, United States, 43210-1257
      • The Ohio State University /ID# 209254
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74132
      • Southside Dermatology /ID# 212004
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Res Center PC /ID# 208807
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University /ID# 208809
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina /ID# 211054
  • Tennessee
    • Jackson, Tennessee, United States, 38305-2163
      • Clinical Research Solutions, LLC /ID# 212542
  • Texas
    • Austin, Texas, United States, 78759-4100
      • Orion Clinical Research /ID# 208765
    • Bryan, Texas, United States, 77802
      • DiscoveResearch, Inc. /ID# 213171
    • Fort Worth, Texas, United States, 76244-6548
      • Epiphany Dermatology - Fort Worth /ID# 211187
    • Kerrville, Texas, United States, 78028-9640
      • Sante Clinical Research /ID# 212970
    • San Antonio, Texas, United States, 78249
      • Stephen Miller, MD PA /ID# 210071
    • Sugar Land, Texas, United States, 77479-3153
      • Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153
  • Utah
    • Salt Lake City, Utah, United States, 84112-5500
      • University of Utah /ID# 209001
  • Virginia
    • Richmond, Virginia, United States, 23220-4459
      • Clinical Research Partners, LLC /ID# 212262
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research /ID# 212142
  • West Virginia
    • South Charleston, West Virginia, United States, 25309
      • West Virginia Research Inst /ID# 212730

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upadacitinib 30 mg QD; Participants 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.	Biological: Upadacitinib; Extended release tablet; Other Names: ABT-494; RINVOQ®; Drug: Placebo to dupilumab; Placebo administered as a subcutaneous injection
Experimental: Dupilumab 300 mg EOW; Participants 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.	Biological: Dupilumab; Dupilumab is administered as a subcutaneous (SC) injection; Other Names: Dupixent®; Drug: Placebo to upadacitinib; Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Week 0) to Week 16
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.	Baseline and Week 16
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.	Baseline and Week 16
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.	Baseline (Week 0) to Week 4
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.	Baseline and Week 2
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.	Baseline (Week 0) to Week 1
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).	Baseline and Week 16

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General 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. Erratum In: JAMA Dermatol. 2022 Feb 1;158(2):219. JAMA Dermatol. 2022 Feb 1;158(2):219. JAMA Dermatol. 2024 Feb 14;:

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): August 27, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Upadacitinib; Atopic Dermatitis; Dupilumab; ABT-494
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Immunologic Factors; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Antibodies, Monoclonal; Upadacitinib
• Other Study ID Numbers: M16-046; 2018-002264-57 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes