Hidradenitis Suppurativa (HS)NCT06926192
Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa
An observational study of Hidradenitis Suppurativa (HS) and Hidradenitis Suppurativa (Acne Inversa), run by Peking Union Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS), Hidradenitis Suppurativa (Acne Inversa), Secukinumab
- What is being tested?
- Surgery combined with secukinumab
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 21 Jun 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College
Nanjing, Jiangsu, 210042
Youjun ZHENG, +61 19943909917, 19943909917@163.com
About this study
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
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.
Read the 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.
- Being tested
- Surgery combined with secukinumab
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery combined with secukinumabCombination product
Surgery combined with secukinumab
| Study group | Role | What they receive |
|---|---|---|
| Moderate to severe hidradenitis suppurativa | Not described Receives: Combination Product: Surgery combined with secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: week 52
Secondary outcomes (11)
IHS4
the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4)
Measured: week 52
Change in number of inflammatory nodules
Change in number of inflammatory nodules
Measured: week 52
Change in number of abscesses
Change in number of abscesses
Measured: week 52
Change in number of sinus tracts
Change in number of sinus tracts
Measured: week 52
HS related skin pain (NRS30)
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
Measured: week 52
Time to onset of action
Time to onset of action
Measured: week 52
Duration of drug effect
Duration of drug effect
Measured: week 52
Changes in inflammatory markers
white blood cells, erythrocyte sedimentation rate, C-reactive protein
Measured: week 52
DLQI
Dermatology Life Quality Index
Measured: week 52
WPAI
Work Productivity and Activity Impairment
Measured: week 52
Adverse effect and complications
Adverse effect and complications
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2024
- Study completion21 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyou ZHENG, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926192
- Sponsor's protocol ID
- 2025-KY-016
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40023624Calabrese 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. 2026 Apr;40(4):637-645. doi: 10.1111/jdv.20617. Epub 2025 Mar 10.
PubMed 40062409Kohorst 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.
PubMed 28027202Caliezi 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.
PubMed 39941581Agnese 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.
PubMed 38146560Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.
PubMed 22236226