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

NCT06926192 | Recruiting

• 1 other identifier: 2025-KY-016
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• HiSCR

  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 Outcomes (11)

• IHS4

  week 52

• Change in number of inflammatory nodules

  week 52

• Change in number of abscesses

  week 52

• Change in number of sinus tracts

  week 52

• HS related skin pain (NRS30)

  week 52

Study Arms (1)

Moderate to severe hidradenitis suppurativa

Combination Product: Surgery combined with secukinumab

Interventions

Surgery combined with secukinumab COMBINATION_PRODUCT

Surgery combined with secukinumab

Moderate to severe hidradenitis suppurativa

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210042, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 40023624 BACKGROUND

• 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.

  PMID: 40062409 BACKGROUND

• 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.

  PMID: 28027202 BACKGROUND

• 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.

  PMID: 39941581 BACKGROUND

• 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.

  PMID: 38146560 BACKGROUND

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

  PMID: 22236226 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Youjun ZHENG

CONTACT

1+86 9943909917; 19943909917@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 21, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)