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A 24-Week Real-World Study of Upadacitinib in Moderate-to-Severe Hidradenitis Suppurativa

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Hidradenitis suppurativa is a chronic, recurrent inflammatory skin disease characterized by painful inflammatory nodules, abscesses, draining tunnels, and scarring. Patients with moderate-to-severe disease may experience inadequate responses, intolerance, or loss of response to conventional systemic therapies and biologic agents. This prospective, open-label, single-arm, real-world study will evaluate the effectiveness, safety, patient-reported outcomes, and treatment persistence of upadacitinib in 50 adults with moderate-to-severe hidradenitis suppurativa over 24 weeks. Participants will receive oral upadacitinib in routine clinical practice. A starting dose of 15 mg once daily is recommended. The dose may be increased to 30 mg once daily based on disease severity, treatment response, safety findings, drug accessibility, and shared decision-making between the investigator and the participant. Effectiveness assessments will include the Hidradenitis Suppurativa Clinical Response, abscess and inflammatory nodule count, International Hidradenitis Suppurativa Severity Score System, pain and pruritus numerical rating scales, Dermatology Life Quality Index, disease flares, rescue treatments, and surgical interventions. Safety assessments will include adverse events, serious adverse events, laboratory abnormalities, infections, thromboembolic events, major adverse cardiovascular events, hepatic abnormalities, lipid abnormalities, and cytopenias.
Trial Details
NCT Number NCT07727889
Lead Sponsor Peking Union Medical College
Conditions
(from sponsor)
Hidradenitis Suppurativa (Acne Inversa)
Related terms Hidradenitis Suppurativa
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov