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A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Sponsor: AbbVie
Summary
The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
12 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1533
Start Date
2018-08-09
Completion Date
2030-10-23
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
Placebo
Tablets taken orally once a day
Upadacitinib
Tablets taken orally once a day
Topical corticosteroids (TCS)
Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity. Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Locations (193)
Total Skin and Beauty Derm Ctr /ID# 200548
Birmingham, Alabama, United States
Clinical Research Center AL /ID# 201865
Birmingham, Alabama, United States
ACCEL Research Sites /ID# 213364
Birmingham, Alabama, United States
Advanced Dermatology and Skin Care Centre /ID# 213550
Mobile, Alabama, United States
Alliance Dermatology and MOHs Center, PC /ID#200540
Phoenix, Arizona, United States
Arizona Research Center, Inc. /ID# 200546
Phoenix, Arizona, United States
Clear Dermatology & Aesthetics Center /ID# 201257
Scottsdale, Arizona, United States
University of Arizona /ID# 201059
Tucson, Arizona, United States
Bakersfield Derma & Skin Cance /ID# 200892
Bakersfield, California, United States
Mosaic Dermatology /ID# 200553
Beverly Hills, California, United States
University of California Irvine /ID# 200902
Irvine, California, United States
Therapeutics Clinical Research /ID# 200593
San Diego, California, United States
Stanford University /ID# 200597
Stanford, California, United States
Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822
Aurora, Colorado, United States
Colorado Center for Dermatology, PLLC /ID# 203626
Centennial, Colorado, United States
Duplicate_Western States Clinical Research, Inc. /ID# 201702
Wheat Ridge, Colorado, United States
Dermatology Physicians of Connecticut /ID# 201004
Shelton, Connecticut, United States
Clearlyderm Dermatology /ID# 207709
Boca Raton, Florida, United States
Skin Care Research, LLC /ID# 200812
Boca Raton, Florida, United States
Clinical Research of West Florida, Inc /ID# 203643
Clearwater, Florida, United States
Florida Academic Centers Research and Education /ID# 200544
Coral Gables, Florida, United States
Tory P Sullivan, MD PA /ID# 201174
North Miami Beach, Florida, United States
Park Avenue Dermatology, PA /ID# 201012
Orange Park, Florida, United States
Precision Clinical Research /ID# 208734
Sunrise, Florida, United States
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628
Boise, Idaho, United States
Northwestern University Feinberg School of Medicine /ID# 201646
Chicago, Illinois, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556
Skokie, Illinois, United States
DuPage Medical Group /ID# 202065
Wheaton, Illinois, United States
Deaconess Clinic Downtown /ID# 201001
Evansville, Indiana, United States
Indiana University /ID# 200515
Indianapolis, Indiana, United States
Epiphany Dermatology of Kansas LLC /ID# 203026
Overland Park, Kansas, United States
ORA, Inc. /ID# 202824
Andover, Massachusetts, United States
Tufts Medical Center /ID# 200570
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 200545
Boston, Massachusetts, United States
Clin Res Inst of Michigan, LLC /ID# 208020
Chesterfield, Michigan, United States
Michigan Center for Research Company /ID# 200560
Clarkston, Michigan, United States
MediSearch Clinical Trials /ID# 201006
Saint Joseph, Missouri, United States
Skin Specialists, PC /ID# 200573
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center /ID# 200918
Lebanon, New Hampshire, United States
Psoriasis Treatment Center of Central New Jersey /ID# 200714
East Windsor, New Jersey, United States
Juva Skin and Laser Center /ID# 200997
New York, New York, United States
J. Schwartz, MD, PLLC /ID# 202122
Troy, New York, United States
Bexley Dermatology Research /ID# 200899
Bexley, Ohio, United States
The Ohio State University /ID# 200542
Columbus, Ohio, United States
Vital Prospects Clinical Research Institute, PC /ID# 200901
Tulsa, Oklahoma, United States
Oregon Dermatology and Research Center /ID# 200601
Portland, Oregon, United States
University of Pittsburgh MC /ID# 206057
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital /ID# 200566
Providence, Rhode Island, United States
AAPRI Clinical Research /ID# 221134
Warwick, Rhode Island, United States
Rivergate Dermatology & Skin Care Center /ID# 201698
Goodlettsville, Tennessee, United States
Stones River Dermatology /ID# 204962
Murfreesboro, Tennessee, United States
Arlington Research Center, Inc /ID# 200559
Arlington, Texas, United States
Center for Clinical Studies /ID# 200582
Houston, Texas, United States
Progressive Clinical Research /ID# 201582
San Antonio, Texas, United States
Center for Clinical Studies - Webster TX /ID# 203186
Webster, Texas, United States
Advanced Clinical Research - Woseth Dermatology /ID# 213745
Salt Lake City, Utah, United States
Eastern Virginia Med School /ID# 200994
Norfolk, Virginia, United States
Dermatology Associates of Seattle /ID# 200717
Seattle, Washington, United States
University of Wisconsin - Madison /ID# 204933
Madison, Wisconsin, United States
St George Dermatology & Skin Cancer Centre /ID# 204788
Kogarah, New South Wales, Australia
Royal North Shore Hospital /ID# 204639
St Leonards, New South Wales, Australia
Westmead Hospital /ID# 205682
Westmead, New South Wales, Australia
Veracity Clinical Research /ID# 204793
Woolloongabba, Queensland, Australia
Fremantle Dermatology /ID# 205306
Fremantle, Western Australia, Australia
Medizinische Universitaet Innsbruck /ID# 210897
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 209567
Linz, Upper Austria, Austria
Kepler Universitaetsklinikum GmbH /ID# 201075
Linz, Upper Austria, Austria
Medizinische Universitaet Wien /ID# 201080
Vienna, Vienna, Austria
UZ Brussel /ID# 203557
Jette, Brussels Capital, Belgium
UCL Saint-Luc /ID# 202028
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UZ Gent /ID# 202030
Ghent, Oost-Vlaanderen, Belgium
IMTR - Grand Hopital de Charleroi /ID# 202029
Loverval, Belgium
Kirk Barber Research, CA /ID# 200329
Calgary, Alberta, Canada
Dermatology Research Institute Inc. /ID# 200341
Calgary, Alberta, Canada
Alberta DermaSurgery Centre /ID# 205674
Edmonton, Alberta, Canada
Karma Clinical Trials /ID# 200339
St. John's, Newfoundland and Labrador, Canada
Eastern Canada Cutaneous Resea /ID# 200335
Halifax, Nova Scotia, Canada
Lynderm Research Inc. /ID# 200338
Markham, Ontario, Canada
DermEdge Research Inc. /ID# 200337
Mississauga, Ontario, Canada
The Centre for Clinical Trials /ID# 205404
Oakville, Ontario, Canada
Angela Montgomery Medicine Professional Corporation /ID# 212653
Ottawa, Ontario, Canada
SKIN Centre for Dermatology /ID# 200331
Peterborough, Ontario, Canada
The Center For Dermatology /ID# 205409
Richmond Hill, Ontario, Canada
Toronto Research Centre /ID# 205411
Toronto, Ontario, Canada
Research Toronto /ID# 205410
Toronto, Ontario, Canada
XLR8 Medical Research /ID# 205405
Windsor, Ontario, Canada
CHU Sainte-Justine /ID# 206013
Montreal, Quebec, Canada
Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403
Québec, Quebec, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 200330
Saint-Jérôme, Quebec, Canada
Chinese PLA General Hospital /ID# 206786
Beijing, Beijing Municipality, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669
Wuhan, Hubei, China
The First Hospital of China Medical University /ID# 209840
Shenyang, Liaoning, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132
Hangzhou, Zhejiang, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442
Hangzhou, Zhejiang, China
Beijing Friendship Hospital /ID# 207434
Beijing, China
Xiangya Hospital Central South University /ID# 207510
Changsha, China
Huashan Hospital of Fudan University /ID# 207437
Shanghai, China
Fakultni nemocnice Plzen /ID# 202044
Pilsen, Czechia
Sanatorium profesora Arenbergera /ID# 202082
Prague, Czechia
Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248
Prague, Czechia
Vseobecna fakultni nemocnice v Praze /ID# 202045
Prague, Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 205780
Nice, Alpes-Maritimes, France
AP-HM - Hopital de la Timone /ID# 206128
Marseille, Bouches-du-Rhone, France
CHRU Tours - Hopital Gatien de Clocheville /ID# 218209
Tours, Centre-Val de Loire, France
Hopital Saint-Andre /ID# 206129
Bordeaux, France
Polyclinique Courlancy /ID# 201537
Reims, France
Universitaetsklinik Heidelberg /ID# 202097
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Frankfurt /ID# 202095
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Muenster /ID# 202094
Münster, North Rhine-Westphalia, Germany
CMS3 Company for Medical Study /ID# 205195
Selters, Rhineland-Palatinate, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Bonn /ID# 202092
Bonn, Germany
TFS Trial Form Support GmbH /ID# 202096
Hamburg, Germany
Medizinische Hochschule Hannover /ID# 202098
Hanover, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194
Mainz, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093
Munich, Germany
401 GSNA - 401 Army General Hospital /ID# 211963
Athens, Attica, Greece
Children's Hosp P. A. Kyriakou /ID# 217573
Athens, Attica, Greece
University General Hospital Attikon /ID# 201126
Athens, Attica, Greece
General Hospital Andreas Syggros /ID# 201123
Athens, Attica, Greece
Papageorgiou General Hospital Thessaloniki /ID# 202392
Stavroupoli (Thessalonikis), Thessaloniki, Greece
Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124
Thessaloniki, Greece
Prince of Wales Hospital /ID# 205152
Hong Kong, Hong Kong
Queen Mary Hospital /ID# 205146
Hong Kong, Hong Kong
Oroshazi Korhaz /ID# 203525
Orosháza, Bekes County, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 201765
Debrecen, Hajdú-Bihar, Hungary
Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866
Debrecen, Hungary
Allergo-Derm Bakos Kft. /ID# 205361
Szolnok, Hungary
St James Hospital /ID# 201118
Dublin, Dublin, Ireland
South Infirmary Victoria University Hospital /ID# 201079
Cork, Ireland
University Hospital Waterford /ID# 201253
Waterford, Ireland
Soroka University Medical Center /ID# 206652
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 201611
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 201608
Tel Aviv, Tel Aviv, Israel
HaEmek Medical Center /ID# 201958
Afula, Israel
Rabin Medical Center /ID# 201959
Petah Tikva, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014
Rome, Lazio, Italy
Istituto Clinico Humanitas /ID# 200739
Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690
Ancona, Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742
Catania, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744
Milan, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 200751
Naples, Italy
Chukyo Hospital /ID# 202311
Nagoya, Aichi-ken, Japan
Medical Corporation Matsuo Clinic /ID# 202312
Fukuoka, Fukuoka, Japan
Hiroshima University Hospital /ID# 201914
Hiroshima, Hiroshima, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665
Sapporo, Hokkaido, Japan
Hiramoto skin clinic /ID# 204048
Amagasaki-shi, Hyōgo, Japan
National Hospital Organization Sagamihara National Hospital /ID# 201658
Sagamihara-shi, Kanagawa, Japan
Queens Square Medical Center dermatology allergology /ID# 203850
Yokohama, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID#258604
Kyoto, Kyoto, Japan
Kyoto University Hospital /ID# 201654
Kyoto, Kyoto, Japan
Tohoku University Hospital /ID# 206322
Sendai, Miyagi, Japan
Osaka Habikino Medical Center /ID# 204243
Habikino-shi, Osaka, Japan
Jichi Medical University Hospital /ID# 201913
Shimotsuke-shi, Tochigi, Japan
Juntendo University Hospital /ID# 202888
Bunkyo-ku, Tokyo, Japan
Tokai University Hachioji Hospital /ID# 201711
Hachioji-shi, Tokyo, Japan
Maruyama Dermatology Clinic /ID# 202350
Koto-ku, Tokyo, Japan
Yamate Dermatological Clinic /ID# 202130
Shinjuku-ku, Tokyo, Japan
Erasmus Medisch Centrum /ID# 202196
Rotterdam, South Holland, Netherlands
Academisch Medisch Centrum /ID# 202193
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen /ID# 202195
Groningen, Netherlands
Universitair Medisch Centrum Utrecht /ID# 202194
Utrecht, Netherlands
Clinical Trials NZ /ID# 205336
Hamilton, New Zealand
Haukeland University Hospital /ID# 201152
Bergen, Hordaland, Norway
Universitetssykehuset N-Norge, Harstad /ID# 201269
Harstad, Troms, Norway
Universitetssykehuset N-Norge, Tromso /ID# 201270
Tromsø, Troms, Norway
Rikshospitalet OUS HF /ID# 201271
Oslo, Norway
Dr. Samuel Sanchez PSC /ID# 202002
Caguas, Puerto Rico
Clinical Research Puerto Rico /ID# 203644
San Juan, Puerto Rico
GCM Medical Group PSC - Hato Rey /ID# 202003
San Juan, Puerto Rico
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372
Banská Bystrica, Slovakia
Univerzitna nemocnica Martin /ID# 203851
Martin, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240
Nové Zámky, Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373
Prešov, Slovakia
Hospital Universitario de Puerto Real /ID# 200875
Puerto Real, Cadiz, Spain
Hospital General Universitario Alicante /ID# 200873
Alicante, Spain
Hospital Santa Creu i Sant Pau /ID# 201325
Barcelona, Spain
Hospital Universitario de la Princesa /ID# 201517
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 201135
Madrid, Spain
Hospital Universitario La Paz /ID# 205438
Madrid, Spain
Skane University Hospital Lund /ID# 201244
Lund, Skåne County, Sweden
Sahlgrenska University Hospital /ID# 201274
Gothenburg, Västra Götaland County, Sweden
Sodersjukhuset /ID# 201242
Stockholm, Sweden
Karolinska University Hospital /ID# 201243
Stockholm, Sweden
Barts Health NHS Trust /ID# 201044
London, London, City of, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 201193
London, London, City of, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 204642
London, London, City of, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 202052
Oxford, Oxfordshire, United Kingdom
NHS Tayside /ID# 202081
Dundee, Scotland, United Kingdom
NHS Greater Glasgow and Clyde /ID# 201374
Glasgow, Scotland, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 201106
Leeds, United Kingdom