2022-502168-19-00招募中2 期
INCA34176-254: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 70
- 试验地点
- 32
- 主要终点
- Overall response (OR) at 6 months, defined for each treatment group as CR or PR at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Criteria
研究概览
简要总结
The primary objective is to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •At least 12 years of age at the time of informed consent. Note: Participants aged 12 to ˂ 18 years will not be enrolled in Germany, Italy, and the UK.
- •New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Criteria
- •History of 1 allo-SCT
- •Willingness to avoid pregnancy or fathering children
排除标准
- •Participants who received more than 1 prior allo-SCT. Prior autologous HCT is allowed.
- •Has overlap cGVHD, defined as the presence of features or characteristics of aGVHD with simultaneous diagnostic and/or distinctive features of cGVHD.
- •Prior systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis.
- •Received systemic corticosteroids within 2 weeks prior to C1D1, regardless of indication, except for physiological replacement doses of corticosteroids (ie, < 10 mg/day prednisone equivalent) for adrenal insufficiency.
- •Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D
- •Prior treatment with a JAK inhibitor within 8 weeks before randomization
- •Pregnant or breastfeeding
- •Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
结局指标
主要结局
Overall response (OR) at 6 months, defined for each treatment group as CR or PR at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Criteria
Overall response (OR) at 6 months, defined for each treatment group as CR or PR at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Criteria
次要结局
- Safety and tolerability will be assessed by evaluating the frequency and severity of AEs (including SAEs) and changes in clinical and laboratory assessments.
- DOR (in responders only)
- Proportion of participants with ≥ 7-point improvement in mLSS total score.
- Best overall response in the first 6 months and on study, based on the 2014 NIH Consensus Criteria
- OR at 12 months, defined as CR or PR at 12 months
- PK parameters for axatilimab and ruxolitinib
- • EFS, defined as the time from the date of randomization to the date of addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (ie, non-CR or non-PR by Month 6), whichever occurs first.
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (32)
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