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

Conditions

• Hidradenitis Suppurativa (Acne Inversa)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jul 27, 2026

Start date

Jul 1, 2026

Status verified

Jul 2026

Primary completion

Jul 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

50 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Upadacitinib
  Participants will receive oral upadacitinib for 24 weeks in a routine clinical care setting. The recommended starting dose is 15 mg once daily. The dose may be increased to 30 mg once daily for participants with severe disease, a high inflammatory burden, or an inadequate clinical response, provided that the investigator determines that the potential benefit outweighs the safety risk. Dose adjustments, treatment interruptions, discontinuations, concomitant therapies, and rescue interventions will be documented.

Primary Outcome Measure

Proportion of Participants Achieving HiSCR50 at Week 24 [ Time Frame: Baseline to Week 24 ]