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

Recruiting

• Conditions: Hidradenitis Suppurativa (HS); Hidradenitis Suppurativa (Acne Inversa); Secukinumab

• Registration Number: NCT06926192
• Lead Sponsor: Peking Union Medical College

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-01
• Primary Completion: 2024-12-31
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-16
• Study Completion: 2025-06-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HiSCR	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)

Secondary Outcome Measures

Name	Time	Method
Change in number of inflammatory nodules	week 52	Change in number of inflammatory nodules
Change in number of abscesses	week 52	Change in number of abscesses
Change in number of sinus tracts	week 52	Change in number of sinus tracts
Time to onset of action	week 52	Time to onset of action
Duration of drug effect	week 52	Duration of drug effect
Changes in inflammatory markers	week 52	white blood cells, erythrocyte sedimentation rate, C-reactive protein
IHS4	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)
HS related skin pain (NRS30)	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
DLQI	week 52	Dermatology Life Quality Index
WPAI	week 52	Work Productivity and Activity Impairment
Adverse effect and complications	week 52	Adverse effect and complications

Trial Locations

Locations (1)

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College; 🇨🇳 Nanjing, Jiangsu, China