Clinical trial NCT06926192: Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa
Official title: Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: An Open-label Cohort Study in Real Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa (Acne Inversa)
Secukinumab
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 100
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS

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.

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

Primary outcomes:
measure: HiSCR
timeFrame: week 52
Secondary outcomes:
measure: IHS4
timeFrame: week 52
measure: Change in number of inflammatory nodules
timeFrame: week 52
measure: Change in number of abscesses
timeFrame: week 52
measure: Change in number of sinus tracts
timeFrame: week 52
measure: HS related skin pain (NRS30)
timeFrame: week 52
measure: Time to onset of action
timeFrame: week 52
measure: Duration of drug effect
timeFrame: week 52
measure: Changes in inflammatory markers
timeFrame: week 52
measure: DLQI
timeFrame: week 52
measure: WPAI
timeFrame: week 52
measure: Adverse effect and complications
timeFrame: week 52
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College
state: Jiangsu
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.