NCT07109765

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 31, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

Hidradenitis SuppurativaSecukinumabultrasound

Outcome Measures

Primary Outcomes (1)

  • Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

    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

    From enrollment to the end of treatment at Week 12

Secondary Outcomes (1)

  • Dermatology Life Quality Index

    From enrollment to the end of treatment at week 12

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants were treated at the Department of Dermatology, Peking Union Medical College Hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 1 Shuai Fu Yuan, Dongcheng District, Beijing

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician of dermatology

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start

June 1, 2025

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

August 7, 2025

Record last verified: 2025-07

Locations