NCT06722235招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia
Takeda201 个研究点 分布在 7 个国家目标入组 171 人开始时间: 2025年2月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 171
- 试验地点
- 201
- 主要终点
- Percentage of Participants with Durable Platelet Response
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 low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously [SC]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it.
The participants will be treated with mezagitamab for up to 6 months.
During the study, participants will visit their study clinic several times.
Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •The participant has been diagnosed with ITP that has persisted for at least 12 months.
- •The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist [TPO-RA]), defined as having achieved a platelet count ≥50,000/μL.
- •The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids), and at least 1 currently available second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000/μL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy.
- •The participant has a mean platelet count of less than (<)30,000/μL.
- •If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial.
- •If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention.
排除标准
- •The participant has secondary ITP.
- •The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).
- •The participant has had a splenectomy.
- •The participant has active infection with hepatitis B virus, hepatitis C virus, 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 cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.
- •The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Day
- •The participant has any prior exposure to mezagitamab or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day
- •The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment.
- •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.
- •The participant has used the following immunosuppressive agents as specified prior to the first dose of trial treatment: alkylating agents (e.g., cyclophosphamide) within 8 weeks, vinca alkaloids (e.g., vincristine) within 4 weeks, sulfones (e.g., dapsone) within 3 weeks, antiproliferative agents: (e.g., mycophenolate mofetil, and azathioprine) within 2 weeks, and calcineurin inhibitors: (e.g., cyclosporine) within 2 weeks.
- •The participant has used intravenous immunoglobulin (IVIg), SC immunoglobulin, recombinant human thrombopoietin, anti-D immunoglobulin treatment, or efgartigimod within 4 weeks before signing the ICF or it is expected that any treatment for thrombocytopenia other than the participant's standard-of-care ITP therapy (e.g., rescue therapy, administration of blood products) may be used between screening, and Day
- •The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab/placebo formulation.
- •Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive mezagitamab-matching placebo injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.
干预措施: Placebo (Drug)
Mezagitamab
Experimental
Participants will receive mezagitamab injection, SC, once weekly (QW). They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.
干预措施: Mezagitamab (Drug)
结局指标
主要结局
Percentage of Participants with Durable Platelet Response
时间窗: Up to Week 24
Durable platelet response is defined as platelet count greater than or equal to (≥)50,000/microliter (μL) on at least 4 of the 6 weekly platelet measurements between Weeks 19 and 24.
次要结局
- Number of Participants with Anti-drug Antibodies (ADA)(Predose on Day 1 and at multiple time points post-dose up to Day 169)
- Time to First Platelet Count ≥50,000/μL(Up to Week 24)
- Percentage of Participants Receiving Rescue Therapy(Up to Week 24)
- Percentage of Participants with Platelet Response at Week 16(Week 16)
- Percentage of Participants with Bleeding Events(Up to Week 24)
- Cumulative Number of Weeks with a Platelet Count of ≥50,000/μL(Up to Week 24)
- The Cumulative Number of Weeks with a Platelet Count of ≥30,000/μL(Up to Week 24)
- Percentage of Participants with Complete Platelet Response(Up to Week 24)
- Change from Baseline in the Symptoms Domain Score of the Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) at Weeks 16 and 24(Weeks 16 and 24)
- Number of Participants with Neutralizing ADA(Predose on Day 1 and at multiple time points post-dose up to Day 169)
- Serum Concentration of Mezagitamab During and After Intervention(Predose on Day 1 and at multiple time points post-dose up to Day 169)
- Change in ADA Titers Over Time(Up to Day 169)
研究者
研究点 (201)
Loading locations...
相似试验
已完成
2 期
A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaNCT04278924Takeda41
Unknown
3 期
Proof-of-Concept: A Pilot, Randomized, Double-Blind Study of Oseltamivir Versus Placebo for Immune ThrombocytopeniaImmune ThrombocytopeniaNCT03520049Unity Health Toronto30
Unknown
2 期
Clinical Trial of Gut Microbiota in the Management of Immune ThrombocytopeniaImmune ThrombocytopeniaNCT03033199Shandong University60
招募中
3 期
Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune ThrombocytopeniaPrimary Immune Thrombocytopenia (ITP)NCT05338190Assistance Publique - Hôpitaux de Paris132
已完成
不适用
Study of Immune Thrombocytopenia Pathogenesis:Primary Immune Thrombocytopenia (ITP)NCT02042560Centre Hospitalier Universitaire Dijon89
相关资讯
Takeda's Anti-CD38 Therapy Mezagitamab Achieves 91% Response Rate in Immune Thrombocytopenia Phase II Trial- Mezagitamab, an anti-CD38 monoclonal antibody, demonstrated a 91% platelet response rate in patients with immune thrombocytopenia at the 600mg dose compared to 23% with placebo.
- The Phase II trial enrolled 41 adults with chronic or persistent ITP who had received an average of four prior treatments, addressing an unmet need for 20% of patients who don't benefit from current therapies.
- The therapy showed rapid efficacy, normalizing platelet counts within 48 hours and improving quality of life, with a safety profile similar to placebo.
- Takeda has initiated a Phase III trial with Mass General Brigham Cancer Institute as the leading North American site, with primary completion expected by end of 2027.5 months agoTakeda's Mezagitamab Shows Sustained Kidney Protection 18 Months After Treatment in IgA Nephropathy- Takeda's Phase 1b study demonstrates that mezagitamab (TAK-079) maintains stable kidney function in IgA nephropathy patients through Week 96, 18 months after the last dose.
- The anti-CD38 monoclonal antibody sustained a 55.2% reduction in proteinuria and 50.1% reduction in Gd-IgA1 levels with no serious adverse events reported.
- Mezagitamab has received FDA Breakthrough Therapy Designation for immune thrombocytopenia and EMA Orphan Drug Designation for IgA nephropathy.
- Phase 3 trials are now enrolling patients for both primary IgA nephropathy and chronic immune thrombocytopenia indications.10 months agoBioInvent Receives $1 Million Milestone as Takeda Advances Anti-CD83 Antibody Mezagitamab to Phase 3 for ITP- BioInvent has received a $1 million milestone payment following Takeda's initiation of Phase 3 trials for mezagitamab, an anti-CD83 monoclonal antibody developed for persistent or chronic primary immune thrombocytopenia.
- The antibody, identified from BioInvent's proprietary n-CoDeR® antibody library, has received both Orphan Drug and Fast Track Designations from the FDA, highlighting its potential significance in addressing unmet needs in ITP treatment.
- This advancement validates BioInvent's technology platform and out-licensing strategy, demonstrating the company's ability to generate high-quality drug candidates through strategic partnerships.last year