2025-521692-31-00招募中3 期
A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults with Chronic Primary Immune Thrombocytopenia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 77
- 试验地点
- 26
- 主要终点
- 01. Occurrence of TEAEs and serious TEAEs.
研究概览
简要总结
Safety: To evaluate the long-term safety and tolerability of mezagitamab in participants ≥18 years of age with chronic primary ITP.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Long-term observation for all participants
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •The participant has completed TAK-079-3002 (EOT) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to mezagitamab as demonstrated by meeting the criteria for “platelet response” specified for that trial during either the main study or open-label extension.
- •The participant has provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any trial procedures.
排除标准
- •Key Exclusion criteria for TAK-079-3002 participants: The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.
- •Key Exclusion criteria for TAK-079-1004 participants: The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
- •The participant has had a splenectomy within 3 months before signing the ICF.
- •The participant has received anti-CD20 treatment within 12months before screening and either of the following applies: • The last dose was received within 6 months before screening. • The last dose was received between 6 and 12 months before screening and the participant has a CD19+ count below the lower limit of normal.
- •The participant has received any monoclonal/polyclonal antibody for immunomodulation within 6 months before Day 1.
结局指标
主要结局
01. Occurrence of TEAEs and serious TEAEs.
01. Occurrence of TEAEs and serious TEAEs.
02. Occurrence of TEAEs leading to permanent withdrawal of mezagitamab
02. Occurrence of TEAEs leading to permanent withdrawal of mezagitamab
次要结局
- 01• Duration of platelet response. • Duration between on-demand treatment courses. • Time to initiation of the first on-demand treatment course. • Occurrence of complete response. • Occurrence of ITP remission.
- 02. Reduction in dose and/or frequency of concomitant ITP medications throughout the trial.
- 03. Use of rescue therapy.
- 04. The PK concentration at selected timepoints during and after intervention.
- 05. Occurrence of ADA and NAb.
研究者
Takeda
Scientific
Takeda Development Center Americas Inc.
研究点 (26)
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