A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Inmagene LLC
- 入组人数
- 13
- 试验地点
- 11
- 主要终点
- Evaluation of Adverse Events in Participants
研究概览
简要总结
The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients.
详细描述
This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 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 < 75 years.
- •Moderate-to-severe AD.
- •Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable.
- •Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception.
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.
- •Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement.
- •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
Cohort 2 IMG-007 Dose 2
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
干预措施: IMG-007 (Drug)
Placebo
Placebo will be administered intravenously 3 times over 4 weeks
干预措施: Placebo (Drug)
Cohort 1 IMG-007 Dose 1
IMG-007 Dose 1 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 atopic dermatitis (AD)
次要结局
- Pharmacokinetic Characterization(Serum concentrations of IMG-007 were measured at Week 4 (pre-dose and post-dose), Week 12 (post-dose), and Week 24 (post-dose).)
- Evaluation of Eczema Area and Severity Index (EASI)(Mean percent change from baseline in Eczema Area and Severity Index (EASI) at week 12.)