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

NCT ID: NCT06926192

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-06-21

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.

Conditions

Hidradenitis Suppurativa (HS); Hidradenitis Suppurativa (Acne Inversa); Secukinumab

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Moderate to severe hidradenitis suppurativa

Surgery combined with secukinumab

Intervention Type: COMBINATION_PRODUCT

Surgery combined with secukinumab

Interventions

Surgery combined with secukinumab

Surgery combined with secukinumab

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College

OTHER

Sponsor Role: lead

Responsible Party

Junyou ZHENG

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Youjun ZHENG

Role: CONTACT

19943909917@163.com

1+86 9943909917

Facility Contacts

Youjun ZHENG

Role: primary

19943909917@163.com

+61 19943909917

References

Fang V, Gupta R, Micheletti RG. Managing Hidradenitis Suppurativa with Biologics and Small Molecule Inhibitors. Dermatol Clin. 2025 Apr;43(2):231-245. doi: 10.1016/j.det.2024.12.008. Epub 2025 Jan 21.

Reference Type: BACKGROUND

PMID: 40023624 (View on PubMed)

Calabrese L, Cartocci A, Rubegni P, French LE, Kendziora B. Efficacy and safety of biologics for hidradenitis suppurativa: A network meta-analysis of phase III trials. J Eur Acad Dermatol Venereol. 2025 Mar 10. doi: 10.1111/jdv.20617. Online ahead of print.

Reference Type: BACKGROUND

PMID: 40062409 (View on PubMed)

Kohorst JJ, Baum CL, Otley CC, Roenigk RK, Pemberton JH, Dozois EJ, Tran NV, Davis MD. Patient Satisfaction and Quality of Life Following Surgery for Hidradenitis Suppurativa. Dermatol Surg. 2017 Jan;43(1):125-133. doi: 10.1097/DSS.0000000000000942.

Reference Type: BACKGROUND

PMID: 28027202 (View on PubMed)

Caliezi A, Rabufetti A, Hunger R, Wolf R, Seyed Jafari SM. Impact of Hidradenitis Suppurativa on Sexual Quality of Life. J Clin Med. 2025 Jan 30;14(3):910. doi: 10.3390/jcm14030910.

Reference Type: BACKGROUND

PMID: 39941581 (View on PubMed)

Agnese ER, Tariche N, Sharma A, Gulati R. The Pathogenesis and Treatment of Hidradenitis Suppurativa. Cureus. 2023 Nov 25;15(11):e49390. doi: 10.7759/cureus.49390. eCollection 2023 Nov.

Reference Type: BACKGROUND

PMID: 38146560 (View on PubMed)

Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.

Reference Type: BACKGROUND

PMID: 22236226 (View on PubMed)

Other Identifiers

2025-KY-016

Identifier Type: -

Identifier Source: org_study_id