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Active, not recruitingPhase 3

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

Key facts

Where
Arlington, Bellaire, Birmingham, Boca Raton, Boise, Boston, Bountiful, Bowling Green, Brandon, Caledonia, Canton, Charleston, Charlotte, Charlottesville, Chicago, Clarkston, Columbus, Coral Gables, Dallas, Delray Beach, Durham, East Syracuse, Encino, Farmington, Fayetteville, Fountain Hills, Grapevine, Hershey, Hollywood, Hot Springs, Houston, Huntington Beach, Indianapolis, Kirksville, Knoxville, Las Vegas, Leawood, Lee's Summit, Los Angeles, Lynchburg, Margate, Mason, Medina, Mill Creek, Murray, New Haven, New Hyde Park, New York, Norfolk, North Little Rock, Oklahoma City, Philadelphia, Phoenix, Plano, Portland, Quincy, Reno, Rocklin, Rogers, Sacramento, Saint Joseph, San Diego, Scottsdale, Skokie, Spokane, Springville, St Louis, Tampa, Thousand Oaks, Tucson, Waterford, Webster, West Lafayette, and Worcester, United StatesSee the 87 sites
Phase
Phase 3

Where in United States

  • Arlington Research Center, Inc /ID# 253805Arlington, United StatesNo longer taking part
  • Bellaire Dermatology Associates /ID# 253797Bellaire, United StatesNo longer taking part
  • Cahaba Dermatology & Skin Health Center /ID# 254876Birmingham, United StatesNo longer taking part
  • Skin Care Research Boca Raton /ID# 253814Boca Raton, United StatesNo longer taking part
  • Treasure Valley Medical Research /ID# 255208Boise, United StatesNo longer taking part
  • Beth Israel Deaconess Medical Center /ID# 253811Boston, United StatesNo longer taking part
  • Massachusetts General Hospital /ID# 261093Boston, United StatesNo longer taking part
  • Cope Family Medicine - Ogden Clinic /ID# 276227Bountiful, United StatesNo longer taking part
  • Equity Medical, LLC /ID# 271140Bowling Green, United StatesNo longer taking part
  • Apex Clinical Trials /ID# 255756Brandon, United StatesNo longer taking part
  • The Derm Institute Of West Michigan /ID# 275948Caledonia, United StatesNo longer taking part
  • Apex Clinical Research Center, LLC /ID# 275956Canton, United StatesNo longer taking part
  • Hamzavi Dermatology - Canton /ID# 275856Canton, United StatesNo longer taking part
  • Medical University of South Carolina /ID# 272569Charleston, United StatesNo longer taking part
  • Onsite Clinical Solutions - Community House Rd - Charlotte /ID# 254854Charlotte, United StatesNo longer taking part
  • University of Virginia - Dermatology /ID# 254535Charlottesville, United StatesNo longer taking part
  • DeNova Research /ID# 254372Chicago, United StatesNo longer taking part
  • Northwestern University Feinberg School of Medicine /ID# 254503Chicago, United StatesNo longer taking part
  • Michigan Center for Medical Research - Clarkston /ID# 275860Clarkston, United StatesNo longer taking part
  • Centricity Research - Columbus /ID# 255470Columbus, United StatesNo longer taking part
  • ClinOhio Research Services /ID# 254851Columbus, United StatesNo longer taking part
  • Florida Academic Dermatology Center /ID# 254011Coral Gables, United StatesNo longer taking part
  • Dermatology Treatment and Research Center /ID# 253795Dallas, United StatesNo longer taking part
  • HRMD Research Dallas /ID# 255256Dallas, United StatesNo longer taking part
  • Modern Research Associates /ID# 253810Dallas, United StatesNo longer taking part
  • Dermatology Associates of the Palm Beaches /ID# 275950Delray Beach, United StatesNo longer taking part
  • Duke University Medical Center /ID# 256898Durham, United StatesNo longer taking part
  • Empire Dermatology /ID# 276241East Syracuse, United StatesNo longer taking part
  • Private Practice - Dr. Tooraj Raoof /ID# 254374Encino, United StatesNo longer taking part
  • UConn Health Main /ID# 254507Farmington, United StatesNo longer taking part
  • Clinical Trials Institute - Northwest Arkansas /ID# 254924Fayetteville, United StatesNo longer taking part
  • Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564Fountain Hills, United StatesNo longer taking part
  • Dallas Fort Worth Clinical Research Associates (DFWCRA) /ID# 256438Grapevine, United StatesNo longer taking part
  • Penn State Milton S. Hershey Medical Center /ID# 254925Hershey, United StatesNo longer taking part
  • Skin Care Research - Hollywood /ID# 254508Hollywood, United StatesNo longer taking part
  • Burke Pharmaceutical Research /ID# 254238Hot Springs, United StatesNo longer taking part
  • Suzanne Bruce and Associates-Houston /ID# 254228Houston, United StatesNo longer taking part
  • Marvel Clinical Research /ID# 276228Huntington Beach, United StatesNo longer taking part
  • Dawes Fretzin /ID# 254390Indianapolis, United StatesNo longer taking part
  • Cleaver Dermatology /ID# 254391Kirksville, United StatesNo longer taking part
  • Dermatology Associates of Knoxville /ID# 261082Knoxville, United StatesNo longer taking part
  • Las Vegas Dermatology /ID# 272421Las Vegas, United StatesNo longer taking part
  • Vivida Dermatology- Flamingo /ID# 254227Las Vegas, United StatesNo longer taking part
  • U.S. Dermatology Partners Leawood /ID# 255838Leawood, United StatesNo longer taking part
  • Dermatology and Skin Center of Lees Summit /ID# 257546Lee's Summit, United StatesNo longer taking part
  • Dermatology Research Associates /ID# 254846Los Angeles, United StatesNo longer taking part
  • The Education & Research Foundation, Inc. /ID# 254852Lynchburg, United StatesNo longer taking part
  • Life Clinical Trials - N State Rd - Margate /ID# 258613Margate, United StatesNo longer taking part
  • Dermatologists of Southwest Ohio, Inc /ID# 254297Mason, United StatesNo longer taking part
  • Dermatology Partners - Medina /ID# 275939Medina, United StatesNo longer taking part
  • Frontier Dermatology /ID# 254554Mill Creek, United StatesNo longer taking part
  • University of Utah - Murray /ID# 254452Murray, United StatesNo longer taking part
  • Yale University School of Medicine /ID# 254586New Haven, United StatesNo longer taking part
  • NorthWell Health - Dermatology /ID# 254704New Hyde Park, United StatesNo longer taking part
  • Private Practice - Dr. Bobby Buka /ID# 276371New York, United StatesNo longer taking part
  • Schweiger Dermatology, P.C. /ID# 254232New York, United StatesNo longer taking part
  • Virginia Clinical Research /ID# 254538Norfolk, United StatesNo longer taking part
  • Arkansas Research Trials /ID# 254233North Little Rock, United StatesNo longer taking part
  • Lynn Institute of Oklahoma City /ID# 253791Oklahoma City, United StatesNo longer taking part
  • Clinical Research of Philadelphia, LLC /ID# 255308Philadelphia, United StatesNo longer taking part
  • Paddington Testing Co., Inc. /ID# 254394Philadelphia, United StatesNo longer taking part
  • Medical Dermatology Specialists /ID# 254226Phoenix, United StatesNo longer taking part
  • Texas Dermatology Research Center /ID# 254928Plano, United StatesNo longer taking part
  • Oregon Health and Science University /ID# 254929Portland, United StatesNo longer taking part
  • Beacon Clinical Research, LLC /ID# 254419Quincy, United StatesNo longer taking part
  • Skin Cancer and Dermatology Institute - Reno /ID# 254410Reno, United StatesNo longer taking part
  • NorCal Clinical Research /ID# 274219Rocklin, United StatesNo longer taking part
  • NW Arkansas Clinical Trials Center /ID# 254311Rogers, United StatesNo longer taking part
  • Integrative Skin Science and Research /ID# 254930Sacramento, United StatesNo longer taking part
  • University of California Davis Health /ID# 254229Sacramento, United StatesNo longer taking part
  • MediSearch Clinical Trials /ID# 254392Saint Joseph, United StatesNo longer taking part
  • Medderm Associates /ID# 253800San Diego, United StatesNo longer taking part
  • Mayo Clinic - Scottsdale /ID# 254388Scottsdale, United StatesNo longer taking part
  • NorthShore University HealthSystem - Skokie /ID# 254389Skokie, United StatesNo longer taking part
  • Premier Clinical Research /ID# 254847Spokane, United StatesNo longer taking part
  • Springville Dermatology - Springville /ID# 276225Springville, United StatesNo longer taking part
  • SSM Health Saint Louis University Hospital /ID# 256437St Louis, United StatesNo longer taking part
  • Washington University School of Medicine - St. Louis /ID# 254506St Louis, United StatesNo longer taking part
  • Advanced Clinical Research Institute - Tampa /ID# 253746Tampa, United StatesNo longer taking part
  • Avita Clinical Research /ID# 254471Tampa, United StatesNo longer taking part
  • Skin Care Research - Tampa /ID# 256440Tampa, United StatesNo longer taking part
  • Clinical Trials Research Institute /ID# 254466Thousand Oaks, United StatesNo longer taking part
  • Banner University Medicine Dermatology /ID# 255853Tucson, United StatesNo longer taking part
  • Michigan Dermatology Institute /ID# 254468Waterford, United StatesNo longer taking part
  • Center for Clinical Studies Webster /ID# 254242Webster, United StatesNo longer taking part
  • Options Research Group /ID# 254537West Lafayette, United StatesNo longer taking part
  • UMass Memorial Medical Center - Lake Avenue North /ID# 258839Worcester, United StatesNo longer taking part

Trial details

Who runs it
AbbVie
Trial code
NCT05889182EU 2023-503661-28-00
Record updated
20 August 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: Diagnosis of hidradenitis suppurativa (HS) for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of participant); Documented history of previous use of >= 1 tumor necrosis factor (TNF) inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator; Participant must have a total abscess and inflammatory nodule (AN) count of >= 5 at Baseline; HS lesions must be present in at least 2 distinct anatomic areas at Baseline; At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline; Draining fistula count of <= 20 at Baseline.

Exclusion: Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study; Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit; Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit; History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit; Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.

ClinicalTrials.gov NCT05889182 · EU CTIS 2023-503661-28-00