A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
Start Date
6/14/2024
Completion Date
3/1/2027
Summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide. The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility Criteria
Age Range: 18 years to 63 years
Interventions
Upadacitinib 15mg Dose
Dupilumab 300mg Dose
Upadacitinib 30mg Dose
Conditions
Locations
Cahaba Dermatology & Skin Health Center /ID# 263855
Birmingham, Alabama 35244
United States
One Of A Kind Clinical Research Center - Scottsdale /ID# 278675
Scottsdale, Arizona 85253
United States
Clinical Trials Institute - Northwest Arkansas /ID# 267290
Fayetteville, Arkansas 72703
United States
Exalt Clinical Research /ID# 281611
Chula Vista, California 91910
United States
Private Practice - Dr. Tooraj Raoof /ID# 263849
Encino, California 91436
United States
First OC Dermatology /ID# 263349
Fountain Valley, California 92708
United States
NorCal Medical Research /ID# 278397
Greenbrae, California 94904
United States
Allergy & Asthma Associates of Southern California - Mission Viejo /ID# 266574
Mission Viejo, California 92691
United States
Dermatologist Medical Group of North County- Profound Research /ID# 266512
Oceanside, California 92056
United States
Comprehensive Dermatology Center of Pasadena /ID# 281014
Pasadena, California 91105
United States
Stanford University School of Medicine - Redwood City /ID# 263776
Redwood City, California 94063
United States
Integrative Skin Science and Research /ID# 264537
Sacramento, California 95815
United States
West Dermatology La Jolla /ID# 265014
San Diego, California 92121
United States
Clinical Trials Research Institute /ID# 263846
Thousand Oaks, California 91320
United States
Yale University School of Medicine /ID# 263836
New Haven, Connecticut 06510
United States
Clearlyderm Dermatology - West Boca /ID# 264923
Boca Raton, Florida 33428
United States
Skin Care Research Boca Raton /ID# 263733
Boca Raton, Florida 33486-2269
United States
Apex Clinical Trials /ID# 263747
Brandon, Florida 33511
United States
TrueBlue Clinical Research - Brandon /ID# 265037
Brandon, Florida 33511
United States
Life Clinical Trials - Coral Springs /ID# 267195
Coral Springs, Florida 33071
United States
Revival Research - Doral /ID# 263541
Doral, Florida 33122
United States
FXM Clinical Research Ft. Lauderdale /ID# 280911
Fort Lauderdale, Florida 33308
United States
Skin Care Research - Hollywood /ID# 263739
Hollywood, Florida 33021-6748
United States
Solutions Through Advanced Research /ID# 263392
Jacksonville, Florida 32256
United States
GSI Clinical Research, LLC /ID# 263760
Margate, Florida 33063-7011
United States
Research Associates of South Florida /ID# 267291
Miami, Florida 33134
United States
International Dermatology Research /ID# 264961
Miami, Florida 33144
United States
FAX Pharma Clinical Research /ID# 280915
Miami, Florida 33146
United States
Sullivan Dermatology /ID# 263537
Miami, Florida 33162
United States
Lenus Research and Medical Group /ID# 263779
Miami, Florida 33172
United States
Quality Research of South Florida /ID# 266496
Miami Lakes, Florida 33016
United States
Fxm Clinical Research - Miramar /ID# 280934
Miramar, Florida 33027
United States
Global Clinical Professionals (GCP) /ID# 266474
St. Petersburg, Florida 33705
United States
Skin Care Research - Tampa /ID# 263750
Tampa, Florida 33607-6438
United States
Alliance Clinical Research of Tampa /ID# 264531
Tampa, Florida 33615
United States
Encore Medical Research - Weston /ID# 278491
Weston, Florida 33331
United States
Centricity Research Columbus Dermatology /ID# 266529
Columbus, Georgia 31904
United States
Cleaver Medical Group Dermatology /ID# 263788
Dawsonville, Georgia 30534
United States
Georgia Skin & Cancer Clinic /ID# 267199
Savannah, Georgia 31419
United States
Treasure Valley Medical Research /ID# 263738
Boise, Idaho 83706
United States
DeNova Research /ID# 264513
Chicago, Illinois 60610
United States
Northwestern University Feinberg School of Medicine /ID# 264983
Chicago, Illinois 60611-2927
United States
Dawes Fretzin /ID# 264534
Indianapolis, Indiana 46256
United States
Options Research Group /ID# 264564
West Lafayette, Indiana 47906
United States
Dermatology Specialists Research (DS Research) - Kentucky /ID# 263388
Louisville, Kentucky 40241
United States
Velocity Clinical Research at The Dermatology Clinic - Baton Rouge /ID# 267169
Baton Rouge, Louisiana 70808-4691
United States
Boston Specialists /ID# 265810
Boston, Massachusetts 02111-1901
United States
Beth Israel Deaconess Medical Center /ID# 263703
Boston, Massachusetts 02215
United States
Beacon Clinical Research /ID# 263843
Quincy, Massachusetts 02169
United States
Great Lakes Research Group - Bay City /ID# 263535
Bay City, Michigan 48706
United States
Henry Ford Medical Center - New Center One /ID# 263522
Detroit, Michigan 48202-3046
United States
Onyx Clinical Research - Flint - South Linden Road /ID# 267773
Flint, Michigan 48532
United States
MediSearch Clinical Trials /ID# 263579
Saint Joseph, Missouri 64506
United States
Physician Research Collaboration, LLC /ID# 263583
Lincoln, Nebraska 68516
United States
Skin Specialists /ID# 263345
Omaha, Nebraska 68144
United States
Las Vegas Dermatology /ID# 265801
Las Vegas, Nevada 89144
United States
Skin Cancer And Dermatology Institute (Scdi) - Reno /ID# 263771
Reno, Nevada 89509
United States
Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263840
Lebanon, New Hampshire 03766
United States
Forest Hills Dermatology Group @ Union Turnpike /ID# 263755
Kew Gardens, New York 11415
United States
Equity Medical /ID# 265814
New York, New York 10023-7340
United States
Weill Cornell Medicine /ID# 265793
New York, New York 10065
United States
Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 266545
Huntersville, North Carolina 28078-7961
United States
Vital Prospects Clinical Research Institute - Tulsa /ID# 263645
Tulsa, Oklahoma 74136
United States
Oregon Health and Science University /ID# 263736
Portland, Oregon 97239
United States
Clinical Research of Philadelphia /ID# 264972
Philadelphia, Pennsylvania 19114
United States
University of Pittsburgh Medical Center /ID# 264526
Pittsburgh, Pennsylvania 15213
United States
Dermatology Associates of Plymouth Meeting /ID# 267286
Plymouth Meeting, Pennsylvania 19462
United States
Medical University of South Carolina /ID# 263655
Charleston, South Carolina 29425
United States
Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267185
Spartanburg, South Carolina 29307
United States
Health Concepts /ID# 263383
Rapid City, South Dakota 57702
United States
Arlington Research Center, Inc /ID# 263665
Arlington, Texas 76011
United States
Orion Clinical Research /ID# 263658
Austin, Texas 78759
United States
Bellaire Dermatology Associates /ID# 263794
Bellaire, Texas 77401
United States
Studies in Dermatology LLC /ID# 263335
Cypress, Texas 77429
United States
Dermatology Treatment and Research Center /ID# 265812
Dallas, Texas 75230
United States
Modern Research Associates /ID# 263852
Dallas, Texas 75231
United States
BRCR Global - Katy /ID# 267304
Katy, Texas 77450
United States
The Dermatology Institute of South Texas /ID# 267332
McAllen, Texas 78501
United States
Sms Clinical Research /ID# 278676
Mesquite, Texas 75149
United States
Texas Dermatology Research Center /ID# 264528
Plano, Texas 75025
United States
Stride Clinical Research /ID# 267331
Sugar Land, Texas 77479
United States
The Woodlands Dermatology Associates /ID# 266547
The Woodlands, Texas 77380
United States
Dermatology Associates of Tyler /ID# 264980
Tyler, Texas 75703
United States
West Virginia Research Institute - Morgantown /ID# 264930
Morgantown, West Virginia 26505
United States
Dermatology Research Institute - Blackfoot Trail /ID# 270450
Calgary, Alberta T2J 7E1
Canada
Stratica Medical /ID# 270466
Edmonton, Alberta T5K 2V4
Canada
York Dermatology Clinic & Research Centre /ID# 278847
Richmond Hill, Ontario L4C 9M7
Canada
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 277564
Québec, Quebec G1V 4X7
Canada
Centre de Recherche Saint-Louis /ID# 271083
Québec, Quebec G1W 4R4
Canada
Centro de Inmunología y Genética CIGE SAS /ID# 266200
Medellín, Antioquia 050012
Colombia
Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 265088
Barranquilla, Atlántico 80002
Colombia
Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 265092
Bogotá, Cundinamarca 110221
Colombia
Unidad Integral de Endocrinologia (UNIENDO) /ID# 266970
Bogotá, Cundinamarca 110221
Colombia
ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 278461
L’Aquila, L Aquila 67100
Italy
IRCCS Istituto Clinico Humanitas /ID# 278458
Rozzano, Lombardy 20089
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 278460
Rome, Roma 00168
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 278463
Milan, 20122
Italy
Ichinomiya Municipal Hospital /ID# 265068
Ichinomiya, Aichi-ken 491-8558
Japan
Takeoka Dermatology Clinic /ID# 264055
Marugame, Kagawa-ken 763-0074
Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 279353
Kyoto, Kyoto 602-8566
Japan
Kawasaki Medical School Hospital /ID# 266164
Kurashiki, Okayama-ken 701-0192
Japan
Dokkyo Medical University Hospital /ID# 265431
Mibu, Tochigi 321-0293
Japan
Ogikubo Hospital /ID# 278350
Suginami-Ku, Tokyo 167-0035
Japan
Tachikawa Dermatology Clinic /ID# 271912
Tachikawa-shi, Tokyo 190-0023
Japan
Yamanashi Prefectural Central Hospital /ID# 278052
Kofu, Yamanashi 400-0027
Japan
Katahira Dermatology Urology Clinic /ID# 264403
Kagoshima, 890-0063
Japan
NTT Medical Center Tokyo /ID# 265104
Tokyo, 141-8625
Japan
Teikyo University Hospital /ID# 265126
Tokyo, 173-8605
Japan
SCB Research Center /ID# 263217
Bayamón, 00961
Puerto Rico
Private Practice - Dr. Samuel Sanchez /ID# 263199
Caguas, 00727
Puerto Rico
Private Practice - Dr. Alma Cruz /ID# 263216
Carolina, 00985
Puerto Rico
Clinical Research Puerto Rico /ID# 263197
San Juan, 00909-1711
Puerto Rico
GCM Medical Group, PSC /ID# 263218
San Juan, 00917
Puerto Rico
Caribbean Medical Research Center Headlands /ID# 267163
San Juan, 00918-3501
Puerto Rico
Private Practice - Dr. Orasan Remus /ID# 278765
Cluj-Napoca, Cluj 400006
Romania
Dr Tirziu Dermato-Chirurgie SRL /ID# 278661
Timișoara, Timiș County 300188
Romania
FutureMeds S.R.L. /ID# 279203
Galati, 800183
Romania
FutureMeds S.R.L. /ID# 279217
Galati, 800183
Romania
Korea University Ansan Hospital /ID# 263330
Ansan-si, Gyeonggido 15355
South Korea
Soon Chun Hyang University Hospital Bucheon /ID# 263331
Bucheon-si, Gyeonggido 14584
South Korea
Ajou University Hospital - Suwon-si /ID# 263328
Suwon, Gyeonggido 16499
South Korea
Seoul National University Hospital /ID# 263329
Seoul, Seoul Teugbyeolsi 03080
South Korea
Konkuk University Medical Center /ID# 263327
Seoul, Seoul Teugbyeolsi 05030
South Korea
Hospital Universitario Virgen de las Nieves /ID# 278316
Granada, 18014
Spain
Hospital Universitario de La Princesa /ID# 278319
Madrid, 28006
Spain
Hospital Universitario 12 de Octubre /ID# 278315
Madrid, 28041
Spain
Consorci Hospital General Universitario de Valencia /ID# 278306
Valencia, 46014
Spain
Hospital Universitari i Politecnic La Fe /ID# 278307
Valencia, 46026
Spain