Secukinumab Treatment for Moderate to Severe Hidradenitis Suppurativa

Recruiting

• Conditions: Hidradenitis Suppurativa (HS)

• Registration Number: NCT07109765
• Lead Sponsor: Peking Union Medical College

Brief Summary

This single-center, prospective, observational study aimed to evaluate the efficacy and safety of Secukinumab in treating moderate-to-severe hidradenitis suppurativa (HS). The study was conducted from June 1, 2025, to June 1, 2026, and all participants were treated at the Department of Dermatology, Peking Union Medical College Hospital. The study was approved by the Clinical and Research Ethics Committee of the Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (Ethics Approval No. I-24PJ1844). All procedures involving human participants adhered to the Declaration of Helsinki. Written informed consent form was signed and obtained from the participant.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age ≥18 years
• diagnosis of moderate-to-severe HS with Hurley stage II or III
• Disease duration of ≥6 months, presence of at least one draining tunnel or two inflammatory nodules
• inadequate response to prior treatments, such as antibiotics, isotretinoin, or TNF inhibitors

Exclusion Criteria

• active infections (e.g., viral hepatitis, active tuberculosis)
• use of other biologics or systemic immunosuppressants within the past three months
• severe organ dysfunction (e.g., hepatic or renal failure)
• any other conditions that might affect study results

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)	From enrollment to the end of treatment at Week 12	a ≥50% reduction in the combined count of inflammatory nodules and abscesses from baseline, without an increase in the number of abscesses or draining tunnels

Secondary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index	From enrollment to the end of treatment at week 12

Trial Locations

Locations (1)

No. 1 Shuai Fu Yuan, Dongcheng District, Beijing; 🇨🇳 Beijing, Beijing, China