NCT05348681终止2 期
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- Incidence of TEAEs
研究概览
简要总结
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HS for at least 1 year prior to screening
- •HS lesions must be present in at least 2 distinct anatomic areas
- •A total AN count (sum of abscesses and inflammatory nodules) > 6 across all anatomical sites at both the screening and baseline visits
- •Willing to use contraception for the duration of the study
排除标准
- •Presence of other skin conditions which may interfere with study assessments
- •Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection (including latent TB) or history of infection within 4 weeks of screening
- •Body Mass Index (BMI) >48kg/m2
- •Breastfeeding or pregnant
研究组 & 干预措施
RIST4721 400 mg
Experimental
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
干预措施: RIST4721 (Drug)
Placebo
Placebo Comparator
Placebo: 4 placebo tablets once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of TEAEs
时间窗: Baseline to Week 12 (or end of study participation)
Incidence of SAEs
时间窗: Baseline to Week 12 (or end of study participation)
次要结局
- Proportion of Subjects Achieving HiSCR50 at Week 12(Baseline to Week 12)
研究者
研究点 (12)
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