Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa

April 11, 2025 updated by: Junyou ZHENG, Peking Union Medical College

Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: An Open-label Cohort Study in Real Clinical Practice

This study aims to retrospectively analyze the efficacy and safety of secukinumab combined with surgery in treating moderate to severe HS in real-world clinical practice, providing clinical practioners with real-world evidence in HS treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hidradenitis suppurativa (HS) is a chronic, recurrent, and disabling inflammatory disease that occurs in apocrine distribution sites such as the axilla, groin, and perianal region with a worldwide prevalence of approximately 1.5% -4.6%.The pathogenesis is excessive activation of the Th17 type immune response mediated by IL-17, IL-23, resulting in abnormal keratinization of hair follicles, obstruction of sebaceous ducts, and bacterial infection, culminating in abscesses, sinus tracts, and scarring.Patients with moderate to severe HS (Hurley stage II-III) often suffer from a severe decline in their quality of life due to recurrent infections, pain, and dysfunction, and their risk of depression is markedly elevated.Traditional treatments such as antibiotics, glucocorticoids, surgical debridement have limited efficacy, and the recurrence rate of surgery alone is as high as 50% -70%.In recent years, the use of biologic agents such as TNF-α inhibitors has dramatically improved HS outcomes, but 30% to 40% of patients still have an inadequate response to TNF-α inhibitors. Accumulating evidence suggests that the IL-17 pathway plays a key role in HS pathogenesis, that IL-17A expression is upregulated in the skin lesions of HS patients and positively correlates with disease severity. The efficacy and safety of secukinumab in combination with surgery remain unclear.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210042
        • Recruiting
        • Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS

Description

Inclusion Criteria:

  1. Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS
  2. The diagnosis of HS was confirmed by histopathological examination in the Department of Pathology of our hospital
  3. Patients with HS who received secukinumab combined with surgery in the Department of Dermatologic Surgery of our hospital
  4. Patients with complete clinical data followed up for at least 1 year

Exclusion Criteria:

  1. Patients lost to follow-up
  2. Patients with less than one year of follow-up
  3. Patients who received additional adjuvant therapy during the follow-up period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Moderate to severe hidradenitis suppurativa
Combination product: Surgery combined with secukinumab
Surgery combined with secukinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HiSCR
Time Frame: week 52
at least a 50% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline)
week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IHS4
Time Frame: week 52
the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4)
week 52
HS related skin pain (NRS30)
Time Frame: week 52
NRS30 is defined as at least a 30% reduction from baseline and at least a 2-unit reduction in patient's global assessment of skin pain at worst
week 52
Time to onset of action
Time Frame: week 52
Time to onset of action
week 52
Duration of drug effect
Time Frame: week 52
Duration of drug effect
week 52
DLQI
Time Frame: week 52
Dermatology Life Quality Index
week 52
WPAI
Time Frame: week 52
Work Productivity and Activity Impairment
week 52
Adverse effect and complications
Time Frame: week 52
Adverse effect and complications
week 52
Change in number of inflammatory nodules
Time Frame: week 52
Change in number of inflammatory nodules
week 52
Change in number of abscesses
Time Frame: week 52
Change in number of abscesses
week 52
Change in number of sinus tracts
Time Frame: week 52
Change in number of sinus tracts
week 52
Changes in inflammatory markers
Time Frame: week 52
white blood cells, erythrocyte sedimentation rate, C-reactive protein
week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

June 21, 2025

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-KY-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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