Secukinumab Treatment for Moderate to Severe Hidradenitis... | NCT07109765

Studies
Secukinumab Treatment for Moderate to Severe Hidradenitis Suppurativa

NCT07109765

Sponsor

Peking Union Medical College

Status

Recruiting

Last Update Posted

Aug 7, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Hidradenitis Suppurativa (HS)

Interventions

Secukinumab

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Jul 31, 2025

First Submission Date that Met QC Criteria

Jul 31, 2025

First Posted Date

Aug 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2025

Last Update Posted Date

Aug 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiao Ma, Resident physician of dermatology, Peking Union Medical CollegePrincipal Investigator

Lead Sponsor

Peking Union Medical CollegeOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab	Drug	secukinumab 300 mg weekly for five weeks, followed by 300 mg monthly subcutaneous injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Dermatology Life Quality Index		From enrollment to the end of treatment at week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
No. 1 Shuai Fu Yuan, Dongcheng District, Beijing	Recruiting	Beijing	Beijing Municipality	100730	China

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 30, 2025	Jul 30, 2025	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D017497	Hidradenitis Suppurativa

Ancestor Terms

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C555450	secukinumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided