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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

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Helyszínek itt: Egyesült Államok

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

A vizsgálat adatai

Ki végzi
AbbVie
Azonosító
NCT05889182EU 2023-503661-28-00
A regiszteradat frissítve
2026. augusztus 20.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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