Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Sponsor: AbbVie
Summary
Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 300 sites worldwide. Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1328
Start Date
2023-06-21
Completion Date
2028-09
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
Upadacitinib
Oral Tablets
Placebo
Oral Tablets
Locations (285)
Cahaba Dermatology & Skin Health Center /ID# 254876
Birmingham, Alabama, United States
Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564
Fountain Hills, Arizona, United States
Medical Dermatology Specialists /ID# 254226
Phoenix, Arizona, United States
Mayo Clinic - Scottsdale /ID# 254388
Scottsdale, Arizona, United States
Banner University Medicine Dermatology /ID# 255853
Tucson, Arizona, United States
Clinical Trials Institute - Northwest Arkansas /ID# 254924
Fayetteville, Arkansas, United States
Burke Pharmaceutical Research /ID# 254238
Hot Springs, Arkansas, United States
Arkansas Research Trials /ID# 254233
North Little Rock, Arkansas, United States
NW Arkansas Clinical Trials Center /ID# 254311
Rogers, Arkansas, United States
Private Practice - Dr. Tooraj Raoof /ID# 254374
Encino, California, United States
Marvel Clinical Research /ID# 276228
Huntington Beach, California, United States
Dermatology Research Associates /ID# 254846
Los Angeles, California, United States
NorCal Clinical Research /ID# 274219
Rocklin, California, United States
Integrative Skin Science and Research /ID# 254930
Sacramento, California, United States
University of California Davis Health /ID# 254229
Sacramento, California, United States
Medderm Associates /ID# 253800
San Diego, California, United States
Clinical Trials Research Institute /ID# 254466
Thousand Oaks, California, United States
UConn Health Main /ID# 254507
Farmington, Connecticut, United States
Yale University School of Medicine /ID# 254586
New Haven, Connecticut, United States
Skin Care Research Boca Raton /ID# 253814
Boca Raton, Florida, United States
Apex Clinical Trials /ID# 255756
Brandon, Florida, United States
Florida Academic Dermatology Center /ID# 254011
Coral Gables, Florida, United States
Dermatology Associates of the Palm Beaches /ID# 275950
Delray Beach, Florida, United States
Skin Care Research - Hollywood /ID# 254508
Hollywood, Florida, United States
Life Clinical Trials - N State Rd - Margate /ID# 258613
Margate, Florida, United States
Skin Care Research - Tampa /ID# 256440
Tampa, Florida, United States
Advanced Clinical Research Institute - Tampa /ID# 253746
Tampa, Florida, United States
Avita Clinical Research /ID# 254471
Tampa, Florida, United States
Centricity Research - Columbus /ID# 255470
Columbus, Georgia, United States
Treasure Valley Medical Research /ID# 255208
Boise, Idaho, United States
DeNova Research /ID# 254372
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine /ID# 254503
Chicago, Illinois, United States
NorthShore University HealthSystem - Skokie /ID# 254389
Skokie, Illinois, United States
Dawes Fretzin /ID# 254390
Indianapolis, Indiana, United States
Options Research Group /ID# 254537
West Lafayette, Indiana, United States
U.S. Dermatology Partners Leawood /ID# 255838
Leawood, Kansas, United States
Equity Medical, LLC /ID# 271140
Bowling Green, Kentucky, United States
Massachusetts General Hospital /ID# 261093
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 253811
Boston, Massachusetts, United States
Beacon Clinical Research, LLC /ID# 254419
Quincy, Massachusetts, United States
UMass Memorial Medical Center - Lake Avenue North /ID# 258839
Worcester, Massachusetts, United States
The Derm Institute Of West Michigan /ID# 275948
Caledonia, Michigan, United States
Hamzavi Dermatology - Canton /ID# 275856
Canton, Michigan, United States
Michigan Center for Medical Research - Clarkston /ID# 275860
Clarkston, Michigan, United States
Michigan Dermatology Institute /ID# 254468
Waterford, Michigan, United States
Cleaver Dermatology /ID# 254391
Kirksville, Missouri, United States
Dermatology and Skin Center of Lees Summit /ID# 257546
Lee's Summit, Missouri, United States
MediSearch Clinical Trials /ID# 254392
Saint Joseph, Missouri, United States
SSM Health Saint Louis University Hospital /ID# 256437
St Louis, Missouri, United States
Washington University School of Medicine - St. Louis /ID# 254506
St Louis, Missouri, United States
Vivida Dermatology- Flamingo /ID# 254227
Las Vegas, Nevada, United States
Las Vegas Dermatology /ID# 272421
Las Vegas, Nevada, United States
Skin Cancer and Dermatology Institute - Reno /ID# 254410
Reno, Nevada, United States
Empire Dermatology /ID# 276241
East Syracuse, New York, United States
NorthWell Health - Dermatology /ID# 254704
New Hyde Park, New York, United States
Schweiger Dermatology, P.C. /ID# 254232
New York, New York, United States
Private Practice - Dr. Bobby Buka /ID# 276371
New York, New York, United States
Onsite Clinical Solutions - Community House Rd - Charlotte /ID# 254854
Charlotte, North Carolina, United States
Duke University Medical Center /ID# 256898
Durham, North Carolina, United States
Apex Clinical Research Center, LLC /ID# 275956
Canton, Ohio, United States
ClinOhio Research Services /ID# 254851
Columbus, Ohio, United States
Dermatologists of Southwest Ohio, Inc /ID# 254297
Mason, Ohio, United States
Dermatology Partners - Medina /ID# 275939
Medina, Ohio, United States
Lynn Institute of Oklahoma City /ID# 253791
Oklahoma City, Oklahoma, United States
Oregon Health and Science University /ID# 254929
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center /ID# 254925
Hershey, Pennsylvania, United States
Paddington Testing Co., Inc. /ID# 254394
Philadelphia, Pennsylvania, United States
Clinical Research of Philadelphia, LLC /ID# 255308
Philadelphia, Pennsylvania, United States
Medical University of South Carolina /ID# 272569
Charleston, South Carolina, United States
Dermatology Associates of Knoxville /ID# 261082
Knoxville, Tennessee, United States
Arlington Research Center, Inc /ID# 253805
Arlington, Texas, United States
Bellaire Dermatology Associates /ID# 253797
Bellaire, Texas, United States
Dermatology Treatment and Research Center /ID# 253795
Dallas, Texas, United States
Modern Research Associates /ID# 253810
Dallas, Texas, United States
HRMD Research Dallas /ID# 255256
Dallas, Texas, United States
Dallas Fort Worth Clinical Research Associates (DFWCRA) /ID# 256438
Grapevine, Texas, United States
Suzanne Bruce and Associates-Houston /ID# 254228
Houston, Texas, United States
Texas Dermatology Research Center /ID# 254928
Plano, Texas, United States
Center for Clinical Studies Webster /ID# 254242
Webster, Texas, United States
Cope Family Medicine - Ogden Clinic /ID# 276227
Bountiful, Utah, United States
University of Utah - Murray /ID# 254452
Murray, Utah, United States
Springville Dermatology - Springville /ID# 276225
Springville, Utah, United States
University of Virginia - Dermatology /ID# 254535
Charlottesville, Virginia, United States
The Education & Research Foundation, Inc. /ID# 254852
Lynchburg, Virginia, United States
Virginia Clinical Research /ID# 254538
Norfolk, Virginia, United States
Frontier Dermatology /ID# 254554
Mill Creek, Washington, United States
Premier Clinical Research /ID# 254847
Spokane, Washington, United States
Hospital Universitario Austral /ID# 254904
Pilar, Buenos Aires, Argentina
Buenos Aires Skin /ID# 255299
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Instituto de Neumonologia y Dermatologia /ID# 254903
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Psoriahue Med Interdisciplinar /ID# 257202
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Consultorios Reumatologicos Pampa /ID# 255555
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Ciprec (Centro De Investigacion Y Prevencion Cardiovascular) - Barrio Norte /ID# 255474
Buenos Aires, Argentina
Hospital Italiano /ID# 254905
CABA, Argentina
Paratus Clinical Research Woden /ID# 254670
Phillip, Australian Capital Territory, Australia
Momentum Clinical Research /ID# 254411
Darlinghurst, New South Wales, Australia
Skin Health Institute Inc /ID# 254416
Carlton, Victoria, Australia
Sinclair Dermatology - Melbourne /ID# 254412
East Melbourne, Victoria, Australia
The Alfred Hospital /ID# 254414
Melbourne, Victoria, Australia
Medizinische Universitaet Wien /ID# 254096
Vienna, State of Vienna, Austria