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NCT Number: NCT06926192

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

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.

Recruiting

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nanjing, Jiangsu, 210042, China

Location status: Recruiting

Location contact

Youjun ZHENG

CONTACT

[email protected]

+61 19943909917

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Surgery combined with secukinumab

Combination Product

Surgery combined with secukinumab

Primary outcomes

  1. HiSCR

    Time frame: 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 outcomes

  1. IHS4

    Time frame: 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)

  2. Change in number of inflammatory nodules

    Time frame: week 52

    Change in number of inflammatory nodules

  3. Change in number of abscesses

    Time frame: week 52

    Change in number of abscesses

  4. Change in number of sinus tracts

    Time frame: week 52

    Change in number of sinus tracts

  5. HS related skin pain (NRS30)

    Time frame: 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

  6. Time to onset of action

    Time frame: week 52

    Time to onset of action

  7. Duration of drug effect

    Time frame: week 52

    Duration of drug effect

  8. Changes in inflammatory markers

    Time frame: week 52

    white blood cells, erythrocyte sedimentation rate, C-reactive protein

  9. DLQI

    Time frame: week 52

    Dermatology Life Quality Index

  10. WPAI

    Time frame: week 52

    Work Productivity and Activity Impairment

  11. Adverse effect and complications

    Time frame: week 52

    Adverse effect and complications

Study contacts

Contact information is provided by the study sponsor or research team.

Youjun ZHENG

CONTACT

[email protected]

1+86 9943909917

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 13, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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