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
- 发起方
- 入组人数
- 150
- 试验地点
- 123
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
研究概览
简要总结
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.
Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.
During the study, participants will visit their study clinic several times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key Inclusion Criteria:
- •1. The participant has completed TAK-079-3002 (end of trial [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.
排除标准
- •For TAK-079-3002 participants:
- •1. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.
- •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 active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- •History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.
- •In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
- •The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months 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 or polyclonal antibody for immunomodulation within 6 months before Visit
- •The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit
- •The participant has used anticoagulants (for example, vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to Visit
- •10 The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.
- •11. The participant has used the following immunosuppressive agents as specified prior to Visit 1: alkylating agents (for example, cyclophosphamide) within 8 weeks, vinca alkaloids (for example, vincristine) within 4 weeks, sulfones (for example, dapsone) within 3 weeks, antiproliferative agents: (for example, mycophenolate mofetil and azathioprine) within 2 weeks, and calcineurin inhibitors: (for example, cyclosporine) within 2 weeks.
- •12. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.
- •Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Mezagitamab
Eligible participants who completed the TAK-079-3002 or TAK-079-1004 studies can receive on-demand treatment in this continuation study. The on-demand treatment course may be repeated as needed based on the pre-specified on-demand dosing criteria and investigator's clinical judgement.
干预措施: Mezagitamab (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
时间窗: Up to approximately 108 weeks
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2. A serious TEAE is a TEAE that meets 1 or more of the criteria: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or was otherwise considered medically important.
Number of Participants With TEAEs Leading to Permanent Withdrawal of Mezagitamab
时间窗: Up to approximately 108 weeks
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2.
次要结局
- Number of Participants Requiring Rescue Therapy(Up to approximately 108 weeks)
- Serum Concentrations of Mezagitamab(Pre-dose and at multiple time points post-dose up to Week 104)
- Number of Participants With Anti-Drug Antibodies (ADA)(Pre-dose and at multiple time points post-dose up to Week 104)
- Number of Participants With Neutralizing Antibody (NAb)(Pre-dose and at multiple time points post-dose up to Week 104)
- Duration of Platelet Response(Up to approximately 108 weeks)
- Duration Between On-Demand Treatment Courses(Up to approximately 108 weeks)
- Time to Initiation of the First On-Demand Treatment Course(Up to approximately 108 weeks)
- Number of Participants With Complete Response(Up to approximately 108 weeks)
- Number of Participants With Immune Thrombocytopenia (ITP) Remission(Up to approximately 108 weeks)
- Number of Participants With Reduction in Dose and/or Frequency of Concomitant ITP Medications(Up to approximately 108 weeks)