NCT06046729已完成2 期
A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 105
- 主要终点
- Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
研究概览
简要总结
This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of HS for at least 12 months.
- •Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.
- •Have an (abscess plus inflammatory nodule) count of at least
- •Agree to use topical antiseptics daily.
- •Had an inadequate response or intolerance to a 28-day course of oral antibiotics.
排除标准
- •Have more than 20 draining fistulae.
- •Have had surgical treatment for HS in the last 4 weeks before randomization.
- •Have an active skin disease or condition, that could interfere with the assessment of HS.
- •Have a current or recent acute, active infection.
- •Are immunocompromised.
- •Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo will be given.
干预措施: Placebo (Drug)
Eltrekibart Dose 3
Experimental
Eltrekibart will be given SC.
干预措施: Eltrekibart (Drug)
Eltrekibart Dose 1
Experimental
Eltrekibart will be given subcutaneously (SC).
干预措施: Eltrekibart (Drug)
Eltrekibart Dose 2
Experimental
Eltrekibart will be given SC.
干预措施: Eltrekibart (Drug)
结局指标
主要结局
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
时间窗: Week 16
次要结局
- Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules(Baseline, Week 16)
- Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)(Baseline, Week 16)
- Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart(Baseline through Week 16)
研究者
研究点 (105)
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