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临床试验/NCT07261072
NCT07261072尚未招募4 期

Comparison of the Efficacy and Safety of Topical and Subcutaneous Injection of Secukinumab in HS: A Prospective Exploratory Trial

Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Change from Baseline in International HS Severity Score System (IHS4)

研究概览

简要总结

Secukinumab is currently approved in Europe, US and China for the treatment of moderate to severe HS as a biologic agent targeting IL-17A.Two phase III clinical trials (SUNSHINE and SUNRISE) showed that 300 mg s.c. every 2 weeks resulted in 42% to 45% of patients achieving a clinical response (HiSCR) to HS, and the efficacy was sustained through 52 weeks.However, we found in clinical practice that some HS patients present with localized lesions (small areas of involvement, affecting only 1-2 anatomic areas) that are resistant to conventional therapy, and have not yet fulfilled surgical indications, and the need for systemic biologic therapy is controversial.Such patients often experience inadequate response or slow onset of action when they receive secukinumab by routine subcutaneous injection - possibly related to inadequate drug concentration in the focal lesional area and limited local anti-inflammatory effects after systemic administration.In addition, side effects of conventional subcutaneous injection system are greater, and the application is limited in some patients, so it is necessary to explore more appropriate and safer drug delivery method for localized skin lesions.Localized HS, local injection of lesions may enhance anti-inflammatory effects while reducing systemic exposure by increasing drug concentrations at the lesion site.Therefore, exploring novel modes of administration of secukinumab has practical clinical implications based on clinical practice needs and the context of the previous literature.In summary, by exploring the efficacy and safety of local skin injection of secukinumab, this study may provide a new strategy for the treatment of limited HS with sufficient scientific rationale and significant potential benefits and manageable risks.

详细描述

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent painful nodules, abscesses, sinus tracts, and scarring, with a global prevalence of about 1%, occurring in apocrine gland-rich areas such as the axillae and groin. Its pathogenesis is closely related to hair follicle obstruction, dysbacteriosis and immune disorders, in which IL-17A-mediated inflammatory pathways have been demonstrated to be the core driver - IL-17A levels are significantly increased in HS lesions, which can promote neutrophil infiltration and abscess formation.

Secukinumab is currently approved in Europe, US and China for the treatment of moderate to severe HS as a biologic agent targeting IL-17A.Two phase III clinical trials (SUNSHINE and SUNRISE) showed that 300 mg s.c. every 2 weeks resulted in 42% to 45% of patients achieving a clinical response (HiSCR) to HS, and the efficacy was sustained through 52 weeks.However, we found in clinical practice that some HS patients present with localized lesions (small areas of involvement, affecting only 1-2 anatomic areas) that are resistant to conventional therapy, and have not yet fulfilled surgical indications, and the need for systemic biologic therapy is controversial.Such patients often experience inadequate response or slow onset of action when they receive secukinumab by routine subcutaneous injection - possibly related to inadequate drug concentration in the focal lesional area and limited local anti-inflammatory effects after systemic administration.In addition, side effects of conventional subcutaneous injection system are greater, and the application is limited in some patients, so it is necessary to explore more appropriate and safer drug delivery method for localized skin lesions.The successful experience of topical injection of biologics in psoriasis provides an important reference for clinical practice, such as study of nail psoriasis showed that intralesional secukinumab significantly increased local drug concentrations with 73.2% improvement in nail lesions and good safety.This suggests that for localized HS, local injection of lesions may enhance anti-inflammatory effects while reducing systemic exposure by increasing drug concentrations at the lesion site.Therefore, exploring novel modes of administration of secukinumab has practical clinical implications based on clinical practice needs and the context of the previous literature.In summary, by exploring the efficacy and safety of local skin injection of secukinumab, this study may provide a new strategy for the treatment of limited HS with sufficient scientific rationale and significant potential benefits and manageable risks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet international diagnostic criteria for hidradenitis suppurativa
  • Aged ≥ 18 years
  • Disease duration ≥ 6 months and resistance to conventional therapy (no significant improvement for ≥ 3 months)
  • Lesions were confined to a single anatomical area
  • Voluntarily signed the informed consent form and was able to cooperate in all visits and examinations.

排除标准

  • Hypersensitivity to any component of secukinumab injection
  • With severe vital organ failure
  • With active infection or malignancy (malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin and cured)
  • Treatment with biologics, immunosuppressants, or systemic corticosteroids within the last 3 months
  • Pregnant, nursing, or planning conception during the study
  • Mental disorders or cognitive impairment that precludes understanding of study procedures
  • Participating in another clinical study and are at risk of an interaction between the study drugs
  • Other conditions assessed by the investigators as inappropriate for participation in the study

研究组 & 干预措施

Topical injection

Experimental

干预措施: Topical injection of Secukinmab (Other)

Subcutaneous injection

Active Comparator

干预措施: Subcutaneous injection of Secukinumab (Drug)

结局指标

主要结局

Change from Baseline in International HS Severity Score System (IHS4)

时间窗: Baseline (Day 1) and Week 24

IHS4 score is calculated by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild disease, 4 to 10 signifies moderate disease, and 11 or higher signifies severe disease.

次要结局

  • Change from baseline in erythrocyte sedimentation rate (ESR)(Baseline (Day 1) and week4、8、12、16、20、24)
  • Proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR)50(At Week4、8、12、16、20、24)
  • Change from baseline in pain measured by Visual analog scale (VAS)(Baseline (Day 1) and week4、8、12、16、20、24)
  • Change from baseline in Dermatology Life Quality Index (DLQI) Total Score(Baseline (Day 1) and week4、8、12、16、20、24)
  • Change from baseline in white blood cell count (WBC)(Baseline (Day 1) and week4、8、12、16、20、24)
  • Change from baseline in serum level of high-density C-reactive protein (hs-CRP)(Baseline (Day 1) and week4、8、12、16、20、24)
  • Change from baseline in serum level of Interleukin-6 (IL-6)(Baseline (Day 1) and week4、8、12、16、20、24)

研究者

发起方
Peking Union Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Junyou ZHENG

Principal Investigator,

Peking Union Medical College

研究点 (1)

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