A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept Trial With Part B and Open-label Extension of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Q32 Bio Inc.
- 入组人数
- 75
- 试验地点
- 60
- 主要终点
- Part A: Mean relative percent change in SALT score
研究概览
简要总结
Part A is a randomized, double-blind, placebo-controlled, multi-center Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata. All participants in Part A have completed participation.
Part B is a multicenter, open-label study to assess the efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe Alopecia Areata.
详细描述
Part A is a Phase IIa, Randomized, Double-blind, Placebo-controlled, multi-center Proof-of-Concept (POC) study in adult subjects with severe Alopecia Areata (AA). Bempikibart (ADX-914) or matching placebo is administered subcutaneously in the clinic setting every 2 weeks for 24 weeks, with follow-up for 12 weeks. Subjects will be randomized 3:1 to drug vs placebo. All participants in Part A have completed participation.
Part B is a multicenter, open-label study comprised of a screening period of up to 4 weeks, a treatment period of 36 weeks, and a follow-up period of 16 weeks, for a total study duration of up to 56 weeks.
Part A Open Label Extension Cohort is a multicenter, open-label extension to assess the long-term efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe AA who experienced hair regrowth as participants in Part A of the study. Participants enrolled in the Open Label Extension Cohort will receive bempikibart (ADX-914) for a duration of 6 months followed by a 16-week follow-up period.
Part B Open Label Extension Cohort is a multicenter, open-label extension to assess the long-term efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe AA who experienced hair regrowth as participants in Part B of the study. Participants enrolled in the Open Label Extension Cohort will receive bempikibart (ADX-914) for a treatment period of 36 weeks, and follow-up period of 16 weeks, for a total study duration of up to 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part A was double blind-randomized. Part B and OLE are open label.
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
- •Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent.
- •Clinical diagnosis of severe to very severe alopecia areata, defined as the presence of ≥50% total scalp hair loss at screening and baseline as measured by the SALT score.
排除标准
- •History of or diagnosis at screening of any another form of alopecia based on assessment by investigator.
- •History (lifetime) or presence of hair transplants.
- •History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted).
- •Use of systemic, topical, or device-based therapy for AA.
- •History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.
研究组 & 干预措施
Experimental: bempikibart (ADX-914)
200mg dose of bempikibart (ADX-914) administered via injection under the skin
干预措施: bempikibart (ADX-914) (Drug)
结局指标
主要结局
Part A: Mean relative percent change in SALT score
时间窗: 24 Weeks
Part A: Mean relative percent change in SALT score at 24 weeks compared with baseline
Part B: Mean percent change from baseline in SALT score
时间窗: 36 weeks
Part B: Mean percent change from baseline in SALT score at Week 36
次要结局
- Part A: Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.(18 Weeks)
- Part A: Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.(24 Weeks)
- Part A: Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.(24 Weeks)
- Part A: Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24.(24 Weeks)
- Part A: Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.(24 Weeks)
- Part A: Overall Safety as evaluated by number of adverse events (AEs).(36 Weeks)
- Part B: Proportion of participants who achieve ≥50% relative reduction in SALT score compared with baseline at 36 weeks(36 Weeks)
- Part B: Mean percent change from baseline in SALT score at Week 52(52 Weeks)
- Part B: Proportion of participants with absolute SALT score ≤20 and ≤30 at Week 36.(36 Weeks)