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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 61
- 主要终点
- Efficacy of BFB759 in HS
研究概览
简要总结
This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks. The study compares how well BFB759 works and how safe it is compared with a placebo.
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)
盲法说明
Placebo
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
- •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
Active - high dose
BFB759 loading dose followed by BFB759 maintenance high dose every 2 weeks (Q2W) through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive).
干预措施: BFB759 (Biological)
Active - low dose
BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive).
干预措施: BFB759 (Biological)
Placebo
Placebo Q2W for 14 weeks. At Week 16, participants in Placebo group who are still enrolled in the study and receiving treatment will be re-randomized (1:1) into 2 groups (Cross 1 and Cross 2) to receive BFB759
- Cross 1 will receive BFB759 loading dose followed by BFB759 maintenance low-dose Q2W through Week 30 (inclusive).
- Cross 2 will receive BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 30 (inclusive).
干预措施: Placebo for BFB759 (Other)
结局指标
主要结局
Efficacy of BFB759 in HS
时间窗: Baseline to Week 16 and baseline to Week 32
To evaluate the efficacy of BFB759 in adult male and female participants with HS as measured by the change in the number of abscesses and inflammatory nodules (AN count).
次要结局
- Evaluate the clinical activity of BFB759 using HiSCR50(Baseline to Week 16 and baseline to Week 32)
- Evaluate the safety/tolerability of BFB759(routinely over 21 months (about 22 visits during the course of study))
- To evaluate the clinical activity of BFB759 using the International Hidradenitis Suppurativa Severity Score System (IHS4)(Baseline to Week 16 and baseline to Week 32)
- To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS)(Baseline to Week 16 and baseline to Week 32)
- To evaluate the clinical activity of BFB759 using the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA)(Baseline to Week 16 and baseline to Week 32)