Status:
RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 s...
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
- 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.
- 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.
- 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.
Key Trial Info
Start Date :
June 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
1328 Patients enrolled
Trial Details
Trial ID
NCT05889182
Start Date
June 21 2023
End Date
March 1 2028
Last Update
March 4 2026
Active Locations (285)
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1
Cahaba Dermatology & Skin Health Center /ID# 254876
Birmingham, Alabama, United States, 35244
2
Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564
Fountain Hills, Arizona, United States, 85268
3
Medical Dermatology Specialists /ID# 254226
Phoenix, Arizona, United States, 85006
4
Mayo Clinic - Scottsdale /ID# 254388
Scottsdale, Arizona, United States, 85259-5452