NCT07037901招募中2 期
A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Inmagene LLC
- 入组人数
- 405
- 试验地点
- 46
- 主要终点
- Mean percent change from baseline in EASI at Week 20
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
详细描述
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 48 weeks.
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)
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
- •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
- •Male participants must agree to use a highly effective method of contraception
- •EASI score ≥16
- •vIGA-AD score ≥3
- •≥10% body surface area (BSA) of AD involvement
- •Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization
排除标准
- •Positive 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
- •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
- •Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit
研究组 & 干预措施
Placebo Crossover Dose 2
Placebo Comparator
Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
IMG-007 Dose 4
Experimental
Subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
Placebo Crossover Dose 1
Placebo Comparator
Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
Placebo Crossover Dose 1
Placebo Comparator
Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
干预措施: Placebo (Drug)
Placebo Crossover Dose 2
Placebo Comparator
Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol.
干预措施: Placebo (Drug)
IMG-007 Dose 7
Experimental
Subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
IMG-007 Dose 3
Experimental
Subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
IMG-007 Dose 6
Experimental
Subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
IMG-007 Dose 1
Experimental
Subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
IMG-007 Dose 5
Experimental
Subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
IMG-007 Dose 2
Experimental
Subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
结局指标
主要结局
Mean percent change from baseline in EASI at Week 20
时间窗: Baseline, Week 20
次要结局
- Mean percent change from baseline in EASI at Week 16(Baseline, Week 16)
- Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 16 and Week 20, respectively(Week 16, Week 20)
- Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 16 and Week 20, respectively(Week 16, Week 20)
- Incidence and severity of TEAE including treatment-emergent SAEs(Baseline, End of Study)
研究者
研究点 (46)
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相关资讯
ImageneBio Secures $30M Funding to Advance OX40 Antagonist IMG-007 Through Phase 2 Trials- ImageneBio completed a $30 million private placement led by Coastlands Capital, extending cash runway into Q1 2028 and enabling advancement of IMG-007 into Phase 2 clinical trials for alopecia areata.
- The company's Phase 2b ADAPTIVE trial for atopic dermatitis is progressing under an amended protocol evaluating four IMG-007 dosing regimens in approximately 400 patients, with topline data anticipated in Q4 2027.
- IMG-007 demonstrated encouraging safety profile across 150+ subjects with no cases of Kaposi sarcoma, malignancies, or severe infections reported as of March 2026 blinded safety review.
- In alopecia areata proof-of-concept study, IMG-007 showed 30% mean SALT 30 improvement at 36 weeks after three 600mg IV doses in patients with baseline SALT 50 to <95.6 months agoInmagene Initiates Phase 2b Trial of IMG-007 Anti-OX40 Antibody for Moderate-to-Severe Atopic Dermatitis- Inmagene Biopharmaceuticals has dosed the first patient in its ADAPTIVE Phase 2b trial evaluating IMG-007, a non-depleting anti-OX40 monoclonal antibody, for moderate-to-severe atopic dermatitis treatment.
- The randomized, placebo-controlled trial will enroll approximately 220 patients across four treatment arms to evaluate multiple subcutaneous dose regimens over 52 weeks total.
- IMG-007 features an extended half-life of 34.7 days and silenced antibody-dependent cell-mediated cytotoxicity function, potentially minimizing safety risks while enabling convenient dosing.
- Topline results from the dose-finding study are expected in Q4 2026 and will guide optimal dosing regimens for future Phase 3 clinical trials.last year