2025-522440-41-00招募中2 期
A Phase 2, Dose Ranging, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Patients with Moderate to Severe Hidradenitis Suppurativa (COMPASS 2 - HS)
Bluefin Biomedicine Inc.31 个研究点 分布在 5 个国家目标入组 123 人开始时间: 2026年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 123
- 试验地点
- 31
- 主要终点
- Percent change from Baseline (Week 0) at Week 16 in count of AN for Active 1 and Active 2 groups versus Placebo group
研究概览
简要总结
To evaluate the efficacy of BFB759 in adult male and female participants with HS as assessed by the count of abscesses and inflammatory nodules (AN).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Are adults (18 to 75 years) with a diagnosis of hidradenitis suppurativa for at least one year.
- •Have moderate to severe disease not well controlled by systemic antibiotic treatment.
- •Are willing to follow study instructions, attend regular visits, and avoid certain other medications during the study.
排除标准
- •Have certain infections or other immune conditions.
- •Recently used medications that could interfere with the study.
- •Are pregnant or breastfeeding.
研究组 & 干预措施
BFB759
Test
干预措施: BFB759 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from Baseline (Week 0) at Week 16 in count of AN for Active 1 and Active 2 groups versus Placebo group
Percent change from Baseline (Week 0) at Week 16 in count of AN for Active 1 and Active 2 groups versus Placebo group
次要结局
- Safety and tolerability will be assessed by the incidence and severity of TEAEs (described by CTCAE Version 5.0)
- Analysis (Active 1 and Active 2 compared to Placebo): Proportion of participants meeting criteria for HiSCR50 defined as at least a 50% decrease in AN count with no increase in the number of abscesses and no increase in the number of dTs at Week 16 relative to Baseline (Week 0) and over time relative to Baseline (Week 0).
- Proportion of participants meeting criteria for IHS4-90 defined as at least a 90% reduction in IHS4 score at Week 16 relative to Baseline (Week 0).
- Proportion of participants meeting criteria for HiSCR75 defined as at least a 75% decrease in AN count with no increase in the number of abscesses and no increase in the number of dTs at Week 16 relative to Baseline (Week 0) and over time relative to Baseline (Week 0).
- Proportion of participants meeting criteria for HiSCR90 defined as at least a 90% decrease in AN count with no increase in the number of abscesses and no increase in the number of dTs at Week 16 relative to Baseline (Week 0) and over time relative to Baseline (Week 0).
- Percent change from Baseline (Week 0) at Week 16 on the IHS4
- Percent change from Baseline (Week 0) at Week 16 on the skin pain NRS
- Proportion of participants meeting criteria for IHS4-55 defined as at least a 55% reduction in IHS4 score at Week 16 relative to Baseline (Week 0)
研究者
Scott Lonning
Scientific
Bluefin Biomedicine Inc.
研究点 (31)
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