A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease After at Least 2 Lines of Systemic Therapy

Incyte Biosciences Japan G.K.0 个研究点目标入组 20 人开始时间: 2024年7月30日最近更新: 2025年2月5日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 20
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 6age old over 至 No limit（—）
性别: All

入选标准

•At least 6 years of age at the time of signing the ICF.
•Ability to comprehend and willingness to sign a written ICF for the study.
•For participants 6 to 17 years old, a parent/guardian must provide consent for pediatric participants; when applicable, pediatric participants should also sign an assent form.
•Japanese participants who are allo-HSCT recipients with active, refractory, or recurrent cGVHD requiring systemic immune suppression despite at least 2 lines of prior systemic therapy.
•Active cGVHD is defined as the presence of signs and symptoms of cGVHD per the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
•Refractory disease is defined as meeting any of the following criteria:
•The development of 1 or more new sites of disease while being treated for cGVHD.
•Progression of existing sites of disease despite at least 1 month of standard or investigational therapy for cGVHD.
•Participants who did not achieve a response within 3 months on prior therapy for cGVHD and for whom the treating physician believes a new systemic therapy is required.
•Recurrent cGVHD is defined as active, symptomatic disease (after an initial response to prior therapy) based on the NIH 2014 consensus criteria by organ-specific or global assessment or for which the physician believes a new line of systemic therapy is required.
•Participants may have persistent, active aGVHD and cGVHD manifestations (overlap syndrome), as defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
•Karnofsky performance score of >= 60 (if aged 16 years or older); Lansky performance score of >= 60 (if aged younger than 16 years).
•Adequate organ and bone marrow functions evaluated during the 14 days prior to the start of study treatment.
•Creatinine clearance >= 30 mL/min based on the Cockcroft-Gault formula in adult participants and Schwartz formula in pediatric participants.
•Concomitant use of a systemic corticosteroid is allowed but not required. Topical and inhaled corticosteroid agents are allowed. If a participant is taking a corticosteroid, it must be a stable dose for at least 2 weeks prior to the start of study treatment.
•Concomitant use of protocol-defined immunosuppressant is allowed but not required.
•Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

排除标准

•Has aGVHD without manifestations of cGVHD.
•Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
•History of acute or chronic pancreatitis.
•History of myositis.
•History or other evidence of severe illness, uncontrolled infection, allergy to excipients, or any other conditions that would make the participant, in the opinion of the investigator, unsuitable for the study.
•Has acquired immunodeficiency syndrome.
•History of latent or active TB based on protocol-defined criteria.
•Active HBV or HCV infection that requires treatment, or at risk for HBV reactivation (ie, positive HBsAg).
•Pregnant or breastfeeding.
•Previous exposure to CSF-1R targeted therapies.
•Use of any agent other than corticosteroids, or the immunosuppressant for the treatment of cGVHD within 2 weeks or 5 half-lives, whichever is shorter, prior to the start of study treatment.
•Has received an investigational treatment within 28 days prior to the start of study treatment.
•Currently participating in any other interventional study.

结局指标

主要结局

Overall Response Rate in the First 6 Cycles

次要结局

未报告次要终点

研究者

发起方

Incyte Biosciences Japan G.K.

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