CTIS2022-501427-24-00招募中1 期
(Summit) A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of the Safety and Efficacy of CGT9486 in Subjects with NonAdvanced Systemic Mastocytosis - CGT9486-21-202
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 189
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Diagnosed with 1 of the following diagnoses according to the 2022 World Health Organization (WHO) classification for systemic mastocytosis (SM): 1.Indolent systemic mastocytosis (ISM) 2.Smoldering systemic mastocytosis (SSM) 3.Bone marrow mastocytosis (BMM), Moderate-to-severe symptoms based on a disease-specific PRO and after establishing a stable regimen of at least 2 antimediator therapies over a 14-day eligibility period, Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2, Other protocol-defined inclusion criteria apply.
排除标准
- •Diagnosed with any of the following WHO SM classifications: advanced systemic mastocytosis including SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia; or mast cell sarcoma, Diagnosed with mastocytosis of the skin without systemic involvement, History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study, Need for treatment of corticosteroids at >10 mg/day of prednisone or equivalent, Other protocol-defined exclusion criteria apply
研究者
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