NCT05205070Unknown2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in the Treatment of Subjects With Alopecia Areata
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 31
- 主要终点
- Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24
研究概览
简要总结
Efficacy and safety of rosnilimab (ANB030) in subjects with moderate-to-severe Alopecia Areata
详细描述
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group,multicenter study to evaluate the safety, tolerability, and efficacy of rosnilimab in subjects with alopecia areata (AA).This study also will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of rosnilimab and evaluate the immunogenicity of rosnilimab in subjects with AA.
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
Double-blinded design
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
- •Male or nonpregnant, nonlactating female subject aged 18 to 75 years (inclusive) at the time of informed consent.
- •Subjects with a clinical diagnosis of AA defined as having a SALT score ≥ 50 and in which the current episode of hair loss is > 24 weeks (without evidence of spontaneous terminal hair regrowth ≥ 10% within 24 weeks at the time of screening and baseline), but ≤ 8 years (from onset of current episode).
排除标准
- •Concomitant active systemic diseases (except stable thyroid diseases) that may cause hair loss (eg, lupus erythematosus, systemic sclerosis, celiac disease) that could interfere with the Investigators' ability to evaluate the subject's response to therapy.
- •Subject's cause of hair loss is indeterminable and/or in addition to AA they have concomitant causes of alopecia, such as traction alopecia, cicatricial alopecia, lichen planopilaris, frontal fibrosing alopecia, advanced androgenetic alopecia (ie, Ludwig Type III or Norwood-Hamilton Stage ≥ V), telogen effluvium, trichotillomania, or diffuse AA (alopecia areata incognita).
- •Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status (eg, history of splenectomy).
结局指标
主要结局
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24
时间窗: Week 24
次要结局
未报告次要终点
研究者
研究点 (31)
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