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NCT Number: NCT07109765

Secukinumab Treatment for Moderate to Severe Hidradenitis Suppurativa

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.

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Key information

Conditions

Hidradenitis Suppurativa (HS) Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Hidradenitis Suppurativa Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

No. 1 Shuai Fu Yuan, Dongcheng District, Beijing

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Xiao Ma

CONTACT

[email protected]

86-18511599355

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

secukinumab

Drug

secukinumab 300 mg weekly for five weeks, followed by 300 mg monthly subcutaneous injection

Primary outcomes

  1. Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

    Time frame: 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 outcomes

  1. Dermatology Life Quality Index

    Time frame: From enrollment to the end of treatment at week 12

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Registry information

Official study title

Real-World Evaluation of Secukinumab in Moderate-to-Severe Hidradenitis Suppurativa

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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