A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants With 50% or Greater Scalp Hair Loss
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Inmagene LLC
- 入组人数
- 29
- 试验地点
- 17
- 主要终点
- Evaluation of Adverse Events in Participants
研究概览
简要总结
The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.
详细描述
This is a phase 1b/2a, open label study to assess the safety, PK, and efficacy of IMG-007 in adult AA participants with 50% or greater scalp hair loss. The study will consist of two cohorts with three periods: a screening period of up to 5 -weeks, a 16-week treatment period and a 20-week follow- up period. Approximately 6 and 24 participants will be sequentially enrolled into cohort 1 and cohort 2, respectively, to receive three intravenous infusions of IMG-007 over 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥ 18 and ≤ 65 years
- •AA with current episode of hair loss of > 6 months but < 8 years
- •AA with ≥ 50% scalp involvement as defined as SALT score ≥ 50
排除标准
- •Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
- •Evidence of active or latent tuberculosis (TB)
- •History of untreated or inadequately treated TB infection.
- •Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit
- •Concurrent hair loss due to other etiologies
- •Primary "diffuse" type of AA
- •Active inflammatory diseases on the scalp that would interfere with the assessment of AA
- •History or presence of hair transplants or micropigmentation of the scalp
- •Active systemic diseases that may cause hair loss
- •Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
研究组 & 干预措施
IMG-007 Dose 1 (300 mg)
IMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks
干预措施: IMG-007 (Drug)
IMG-007 Dose 2 (600 mg)
IMG-007 Dose 2 (600 mg) will be administered intravenously 3 times over 4 weeks
干预措施: IMG-007 (Drug)
结局指标
主要结局
Evaluation of Adverse Events in Participants
时间窗: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
次要结局
- Evaluation of Severity of Alopecia Tool (SALT)(Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24.)