A Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- Incidence and severity of treatment emergent Adverse Events [Part A]
研究概览
简要总结
This is a Phase II clinical study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of QLS12010 capsules in the treatment of moderate to severe Hidradenitis Suppurativa (HS). The study is comprised of two parts: Part A is a multi-center, open-label, single-dose group proof-of-concept study; Part B is a randomized, double-blind, placebo-controlled dose-ranging study. The overall duration of this study is up to 32 weeks, inclusive of the Screening Period, Treatment Period of up to 24 weeks, and the 4-Week Follow-Up Period for safety assessment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At screening, the diagnosis of Hidradenitis suppurativa (HS), with a duration of HS ≥ 6 months;
- •Have moderately to severely active HS at Screening and baseline
- •According to the assessment of the Investigators, one of the following medical histories exists:
- •Regular systemic antibiotic treatment for HS has been ineffective.
- •The patient is intolerant to or has contraindications for systemic antibiotic treatment for HS.
排除标准
- •Participants has a fistulas/sinus tracts (active and inactive) >20 at Screening or Baseline；
- •History of severe cardiovascular and cerebrovascular diseases occurring within 6 months prior to screening, including but not limited to unstable angina pectoris, New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, cardiomyopathy, cerebral hemorrhage, acute cerebral infarction, etc.;
- •Participants with a history of prior use of Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) degraders, small-molecule IRAK4 inhibitors, or similar agents;
- •Participants who have received treatment with other investigational products (IPs) within 3 months or 5 half-lives (whichever is longer) prior to screening;
- •Pregnant or lactating women, or participants with a positive pregnancy test result at screening;
研究组 & 干预措施
QLS12010 Capsule Dose 1 Group
干预措施: QLS12010 (Drug)
QLS12010 Capsule Dose 2 Group
干预措施: QLS12010 (Drug)
Placebo Group
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of treatment emergent Adverse Events [Part A]
时间窗: up to approximately 24 weeks
Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B]
时间窗: Week 16
次要结局
未报告次要终点