Actively Recruiting
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adults and Adolescents With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Led by AbbVie · Updated on 2026-03-04
1328
Participants Needed
285
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of upadacitinib, an oral medication, in adults and adolescents with moderate to severe hidradenitis suppurativa HS who have not responded well or are intolerant to anti-tumor necrosis factor TNF therapy. HS is a painful inflammatory skin disease affecting areas such as the underarms, groin, and analgenital regions. This phase 3 study is double-blinded, meaning neither participants nor doctors know who receives upadacitinib or placebo. The trial includes three periods and involves about 1328 participants worldwide. Participants will take oral tablets of upadacitinib or placebo once daily for 36 weeks during the first two periods. In Period 1, they are randomly assigned to receive either upadacitinib Dose A or placebo for 16 weeks. In Period 2, based on their response in Period 1, participants are divided into six groups receiving various combinations of upadacitinib doses or placebo for 20 weeks. Eligible participants continue to Period 3, a long-term extension, taking upadacitinib or placebo daily for 68 weeks, followed by a 30-day follow-up. During the study, participants will have regular outpatient visits for medical assessments, side effect monitoring, and questionnaires to track changes in disease activity and adverse events. The main outcomes include the percentage achieving clinical response HiSCR 50 by week 16 and the number of adverse events up to week 108. Secondary outcomes measure changes in draining fistula count, symptom assessments, skin pain, odor, quality of life, and flare occurrence. This thorough monitoring helps evaluate treatment impact and safety over time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hidradenitis suppurativa for at least 6 months prior to baseline
- Previous use of one or more tumor necrosis factor (TNF) inhibitors for HS for at least 12 weeks or one approved non-anti-TNF biologic therapy for at least 16 weeks with inadequate response or intolerance
- Total abscess and inflammatory nodule count of at least 5 at baseline
- HS lesions present in at least two distinct anatomic areas at baseline
- At least one anatomic area with Hurley Stage II or higher at baseline
- Draining fistula count of 20 or fewer at baseline
You will not qualify if you...
- Active skin diseases other than HS that could interfere with HS assessment, including infections requiring systemic treatment within 4 weeks before baseline
- Use of investigational drugs within 30 days or five half-lives before first dose or current enrollment in another interventional study
- Previous treatment with cell-depleting therapies such as anti-CD20 within 12 months before baseline or until B cell counts normalize
- Use of prescription topical therapies for HS within 14 days prior to baseline
- Systemic antibiotic treatment for HS or other chronic inflammatory disorders within 14 days prior to baseline
Research Team
A
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