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A 24-Week Real-World Study of Upadacitinib in Moderate-to-Severe Hidradenitis Suppurativa
Sponsor: Peking Union Medical College
Summary
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.
Official title: A Single-Center, Prospective, Open-Label, Exploratory, Single-Arm Real-World Study of Upadacitinib in Patients With Moderate-to-Severe Hidradenitis Suppurativa
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-07-01
Completion Date
2027-07-01
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
Upadacitinib
Upadacitinib will be administered orally once daily for up to 24 weeks. The recommended starting dose is 15 mg once daily. Dose escalation to 30 mg once daily may be implemented according to clinical response, disease severity, safety findings, participant preference, and drug accessibility. Participants will obtain the medication through a physician's prescription and will bear the medication costs according to routine clinical practice.
Locations (1)
No. 1 Shuai Fu Yuan, Dongcheng District, Beijing
Beijing, Beijing Municipality, China