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Идёт набор NCT06926192

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

— Наблюдательное Hidradenitis Suppurativa (HS) Hidradenitis Suppurativa (Acne Inversa) Secukinumab

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Surgery combined with secukinumab.
Кому может быть актуально
Состояния в реестре: Hidradenitis Suppurativa (HS), Hidradenitis Suppurativa (Acne Inversa), Secukinumab. Базовые параметры: до 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: An Open-label Cohort Study in Real Clinical Practice

Обзор

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.

Подробное описание

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.

Вмешательства

  • Комбинированный продукт Surgery combined with secukinumab
    Surgery combined with secukinumab

Первичные конечные точки

  • HiSCR [Срок оценки: week 52]
Вторичные конечные точки (11)
  • IHS4 [Срок оценки: week 52]
  • Change in number of inflammatory nodules [Срок оценки: week 52]
  • Change in number of abscesses [Срок оценки: week 52]
  • Change in number of sinus tracts [Срок оценки: week 52]
  • HS related skin pain (NRS30) [Срок оценки: week 52]
  • Time to onset of action [Срок оценки: week 52]
  • Duration of drug effect [Срок оценки: week 52]
  • Changes in inflammatory markers [Срок оценки: week 52]
  • DLQI [Срок оценки: week 52]
  • WPAI [Срок оценки: week 52]
  • Adverse effect and complications [Срок оценки: week 52]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science a — Нанкин

Публикации

  • 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
  • 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. 2026 Apr;40(4):637-645. doi: 10.1111/jdv.20617. Epub 2025 Mar 10. PMID 40062409
  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT06926192 · 2025-KY-016

Первоисточники (государственные реестры)

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