A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03738397
Last Updated: 2024-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
673 participants
INTERVENTIONAL
2019-02-21
2020-12-09
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Upadacitinib
Extended release tablet
Placebo to dupilumab
Placebo administered as a subcutaneous injection
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.
Dupilumab
Dupilumab is administered as a subcutaneous (SC) injection
Placebo to upadacitinib
Tablet
Interventions
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Upadacitinib
Extended release tablet
Dupilumab
Dupilumab is administered as a subcutaneous (SC) injection
Placebo to dupilumab
Placebo administered as a subcutaneous injection
Placebo to upadacitinib
Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.
Exclusion Criteria
* 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.
18 Years
76 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Clinical Research Center AL /ID# 210277
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences /ID# 211688
Little Rock, Arkansas, United States
Tien Q Nguyen MD, Inc /ID# 208934
Fountain Valley, California, United States
UCSF Fresno /ID# 213253
Fresno, California, United States
Jonathan Corren, MD. INC /ID# 208987
Los Angeles, California, United States
California Allergy and Asthma Medical Group /ID# 213680
Los Angeles, California, United States
Dermatology Research Associates /ID# 209097
Los Angeles, California, United States
Los Angelos Cataract Center /ID# 208524
Los Angeles, California, United States
Dermatology Clinical Trials /ID# 214622
Newport Beach, California, United States
UC Davis Health /ID# 209285
Sacramento, California, United States
Ucsd /Id# 208990
San Diego, California, United States
Clinical Science Institute /ID# 211022
Santa Monica, California, United States
The Community Research of South Florida /ID# 211145
Hialeah, Florida, United States
Miami Dermatology and Laser Institute /ID# 212938
Miami, Florida, United States
Florida International Rsrch cr /ID# 211562
Miami, Florida, United States
Progressive Medical Research /ID# 211994
Port Orange, Florida, United States
GCP Research /ID# 216020
St. Petersburg, Florida, United States
Clinical Research Trials of Florida, Inc. /ID# 210751
Tampa, Florida, United States
Integrated Clinical Research LLC /ID# 208831
West Palm Beach, Florida, United States
Georgia Pollens Clinical Research Centers, Inc /ID# 211092
Albany, Georgia, United States
Meridian Clinical Research Dermatology /ID# 213251
Savannah, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 208680
Chicago, Illinois, United States
Medical Dermatology Associates of Chicago /ID# 210265
Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058
Normal, Illinois, United States
Dawes Fretzin, LLC /ID# 209187
Indianapolis, Indiana, United States
Beacon Clinical Research, LLC /ID# 209280
Quincy, Massachusetts, United States
Clarkston Skin Research /ID# 208739
Clarkston, Michigan, United States
Henry Ford Health System /ID# 208741
Detroit, Michigan, United States
Clinical Research Institute, Inc /ID# 210852
Minneapolis, Minnesota, United States
Allergy, Asthma & Immunology Associates, PC /ID# 213481
Lincoln, Nebraska, United States
Skin Specialists, PC /ID# 208843
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center /ID# 213727
Lebanon, New Hampshire, United States
Forest Hills Dermatology Group /ID# 209249
Kew Gardens, New York, United States
Montefiore Medical Center /ID# 209647
The Bronx, New York, United States
Wake Forest Univ HS /ID# 208892
Winston-Salem, North Carolina, United States
Univ Hosp Cleveland /ID# 208852
Cleveland, Ohio, United States
The Ohio State University /ID# 209254
Columbus, Ohio, United States
Southside Dermatology /ID# 212004
Tulsa, Oklahoma, United States
Oregon Medical Res Center PC /ID# 208807
Portland, Oregon, United States
Oregon Health and Science University /ID# 208809
Portland, Oregon, United States
Medical University of South Carolina /ID# 211054
Charleston, South Carolina, United States
Clinical Research Solutions, LLC /ID# 212542
Jackson, Tennessee, United States
Orion Clinical Research /ID# 208765
Austin, Texas, United States
DiscoveResearch, Inc. /ID# 213171
Bryan, Texas, United States
Epiphany Dermatology - Fort Worth /ID# 211187
Fort Worth, Texas, United States
Sante Clinical Research /ID# 212970
Kerrville, Texas, United States
Stephen Miller, MD PA /ID# 210071
San Antonio, Texas, United States
Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153
Sugar Land, Texas, United States
University of Utah /ID# 209001
Salt Lake City, Utah, United States
Clinical Research Partners, LLC /ID# 212262
Richmond, Virginia, United States
Premier Clinical Research /ID# 212142
Spokane, Washington, United States
West Virginia Research Inst /ID# 212730
South Charleston, West Virginia, United States
Holdsworth House Medical Practice /ID# 214565
Darlinghurst, New South Wales, Australia
The Skin Hospital /ID# 214401
Darlinghurst, New South Wales, Australia
Veracity Clinical Research /ID# 211134
Woolloongabba, Queensland, Australia
Sinclair Dermatology /ID# 209395
East Melbourne, Victoria, Australia
Burswood Dermatology /ID# 214875
Victoria Park, Western Australia, Australia
Kirk Barber Research, CA /ID# 209504
Calgary, Alberta, Canada
Dermatology Research Institute Inc. /ID# 210942
Calgary, Alberta, Canada
Dr. Chih-ho Hong Medical Inc. /ID# 211032
Surrey, British Columbia, Canada
Enverus Medical Research /ID# 209503
Surrey, British Columbia, Canada
Dr. Wei Jing Loo Medicine Prof /ID# 211400
London, Ontario, Canada
Lynderm Research Inc. /ID# 209505
Markham, Ontario, Canada
DermEdge Research Inc. /ID# 211122
Mississauga, Ontario, Canada
Niakosari Medicine Professional Corporation /ID# 211401
Toronto, Ontario, Canada
K. Papp Clinical Research /ID# 209509
Waterloo, Ontario, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 209498
Saint-Jérôme, Quebec, Canada
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 209935
Zagreb, City of Zagreb, Croatia
Djecja bolnica Srebrnjak /ID# 209939
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 209976
Zagreb, City of Zagreb, Croatia
Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 209937
Ivanić-Grad, Zagreb County, Croatia
Fakultni Nemocnice Brno /ID# 212968
Brno, , Czechia
FN Hradec Kralove /ID# 209116
Hradec Králové, , Czechia
Nemocnice Jihlava, prispevkova organizace /ID# 209131
Jihlava, , Czechia
Fakultni nemocnice Ostrava /ID# 209117
Ostrava, , Czechia
Fakultni Nemocnice v Motole /ID# 209209
Prague, , Czechia
Keski-pohjanmaa Central Hospital /ID# 209534
Kokkola, Keski-Pohjanmaa, Finland
Oulu University Hospital /ID# 208961
Oulu, North Ostrobothnia, Finland
Mikkeli Central Hospital /ID# 210125
Mikkeli, , Finland
Pihlajalinna Turku /ID# 209599
Turku, , Finland
CHRU Lille - Hopital Claude Huriez /ID# 209317
Lille, Hauts-de-France, France
CHU de Nantes - Hotel Dieu /ID# 208974
Nantes, Pays de la Loire Region, France
Charles Nicolle CHU Rouen /ID# 208973
Rouen, Seine-Maritime, France
Hopital de la Timone /ID# 211245
Marseille, , France
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 213374
Nice, , France
Polyclinique Courlancy /ID# 208975
Reims, , France
Hopital Larrey - CHU de Toulouse /ID# 208976
Toulouse, , France
Universitatsklinikum Munster /ID# 210935
Munster, Lower Saxony, Germany
Gemeinschaftspraxis /ID# 211174
Blankenfeld-mahlow, , Germany
Hautklinik Klinikum Darmstadt /ID# 210938
Darmstadt, , Germany
Universitaetsklinikum Frankfurt /ID# 210934
Frankfurt, , Germany
Medizinische Hochschule Hannover /ID# 210939
Hanover, , Germany
TU Uniklinik Munchen /ID# 210937
Munich, , Germany
Oroshazi Korhaz /ID# 210150
Orosháza, Bekes County, Hungary
Uno Medical Trials Kft /ID# 211177
Budapest XIII, , Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 210893
Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktat /ID# 210149
Kaposvár, , Hungary
Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 210892
Pécs, , Hungary
St Vincent's University Hosp /ID# 208441
Dublin, , Ireland
University Hospital Waterford /ID# 208442
Waterford, , Ireland
HaEmek Medical Center /ID# 210153
Afula, , Israel
Rabin Medical Center /ID# 210012
Petah Tikva, , Israel
Sheba Medical Center /ID# 210013
Ramat Gan, , Israel
Ichilov Medical Center /ID# 210014
Tel Aviv, , Israel
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 210632
Milan, Lombardy, Italy
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 215726
Rozzano, Milano, Italy
A.O. Policlinico Sant'Orsola Malpighi /ID# 209111
Bologna, , Italy
A.O.U. di Brescia /ID# 209115
Brescia, , Italy
Ospedale San Giovanni di Dio /ID# 209109
Cagliari, , Italy
AO Univ di Modena /ID# 209110
Modena, , Italy
Policlinico Univ Tor Vergata /ID# 209112
Rome, , Italy
Hospital Sultan Ismail /ID# 211037
Johor Bahru, Johor, Malaysia
Hospital Pakar Sultanah Fatimah /ID# 210185
Muar town, Johor, Malaysia
UKM Medical Centre /ID# 209178
Kuala Lumpur, Selangor, Malaysia
Hospital Pulau Pinang /ID# 210212
George Town, , Malaysia
University Malaya Med Ctr /ID# 208861
Kuala Lumpur, , Malaysia
Hospital Putrajaya /ID# 209177
Putrajaya, , Malaysia
Bravis Ziekenhuis /ID# 208584
Bergen op Zoom, North Brabant, Netherlands
Academisch Medisch Centrum /ID# 208578
Amsterdam, North Holland, Netherlands
Centrum Oosterwal /ID# 209641
Alkmaar, , Netherlands
Universitair Medisch Centrum Groningen /ID# 208583
Groningen, , Netherlands
Erasmus Medisch Centrum /ID# 208582
Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 208579
Utrecht, , Netherlands
Optimal Clinical Trials Ltd /ID# 209475
Auckland, , New Zealand
Clinical Trials NZ /ID# 215590
Hamilton, , New Zealand
Wellington Hospital (Capital and Coast District Health Board) /ID# 215001
Wellington, , New Zealand
St. Olavs Hospital HF /ID# 209137
Trondheim, Sor-Trondelag, Norway
Universitetssykehuset N-Norge, Harstad /ID# 209105
Harstad, Troms, Norway
Universitetssykehuset N-Norge, Tromso /ID# 209103
Tromsø, Troms, Norway
Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy /ID# 211103
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Pratia MCM Krakow /ID# 207444
Krakow, Lesser Poland Voivodeship, Poland
Klinika Ambroziak Sp. z o.o. /ID# 207443
Warsaw, Masovian Voivodeship, Poland
Royalderm Agnieszka Nawrocka /ID# 211015
Warsaw, Masovian Voivodeship, Poland
ClinicMed Daniluk, Nowak Sp.j. /ID# 211112
Bialystok, Podlaskie Voivodeship, Poland
Dermoklinika Medical Center /ID# 211026
Lodz, Łódź Voivodeship, Poland
National Skin Centre /ID# 208775
Singapore, Central Singapore, Singapore
National University Hospital /ID# 208774
Singapore, , Singapore
Singapore General Hospital /ID# 208776
Singapore, , Singapore
Hospital Universitario de Bellvitge /ID# 207063
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Dr. Negrin /ID# 208969
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital de Manises /ID# 207062
Manises, Valencia, Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 207139
Pontevedra, , Spain
Hospital Universitario Arnau Vilanova /ID# 207065
Valencia, , Spain
Hospital Universitario y Politecnico La Fe /ID# 207064
Valencia, , Spain
Skanes Universitetssjukhus /ID# 206783
Malmo, Skåne County, Sweden
Karolinska University Hospital /ID# 207909
Stockholm, , Sweden
China Medical University Hosp /ID# 209770
Taichung, Taichung, Taiwan
National Taiwan University Hospital /ID# 208309
Taipei City, Taipei, Taiwan
Chung Shan Medical University /ID# 208311
Taichung, , Taiwan
Taipei Municipal Wan Fang Hospital /ID# 209987
Taipei, , Taiwan
Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 210435
Zaporizhzhya, Zaporizhzhia Oblast, Ukraine
Kyiv City Clinical Skin and Venereal Hospital /ID# 210755
Kyiv, , Ukraine
ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210434
Rivne, , Ukraine
Royal Alex Childrens County Hospital /ID# 209709
Brighton, Brighton And Hove, United Kingdom
Victoria Hospital /ID# 209853
Kirkcaldy, Fife, United Kingdom
Royal Hospital for Children /ID# 210451
Glasgow, Glasgow City, United Kingdom
The Royal Free Hospital /ID# 208659
London, London, City of, United Kingdom
Guy's and St Thomas' NHS Found /ID# 208881
London, London, City of, United Kingdom
Cardiff & Vale University Health Board /ID# 209745
Cardiff, Wales, United Kingdom
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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2018-002264-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-046
Identifier Type: -
Identifier Source: org_study_id
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