A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Designed Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Weekly Subcutaneous Injection in Patients With Primary Immune Thrombocytopenia
概览
- 阶段
- 2 期
- 干预措施
- HBM9161 Dose A
- 疾病 / 适应症
- Primary Immune Thrombocytopenic Purpura
- 发起方
- Harbour BioMed (Guangzhou) Co. Ltd.
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Proportion of patients who achieve the early response.
- 状态
- 已完成
- 最后更新
- 4天前
概览
简要总结
To select a dose and to make a decision for Phase 3 study
详细描述
The onset of primary immune thrombocytopenia is thought to be increased platelet destruction and decreased platelet production due to anti-platelet antibodies. HBM9161 is a fully human anti-FcRn monoclonal antibody that can effectively remove pathogenic IgG, thereby relieving platelet destruction and rapidly increasing platelet counts in patients. The study will be conducted in a Phase 2/3 operational seamless design, with group Dose A and Dose B of HBM9161 and a placebo group in Phase 2.
研究者
入排标准
入选标准
- •≥ 18 years of age at the screening visit, male or female.
- •Persistent or chronic ITP whose average number of platelet at the screening visit and pre-dose (at least 1 day apart) is \< 30 × 10\^9/L, and not \> 35 × 10\^9/L for any of two tests. No severe bleeding within 4 weeks prior to the screening visit.
- •Patients who have received and failed at least 1 first line of ITP therapy (glucocorticoids and/or intravenous gamma globulin), or who are contraindicated, intolerable, or refuse standard therapy.
- •Patients will be allowed to use a stable dose of concomitant drugs for the treatment of ITP. e.g., glucocorticoid, danazol, immunosuppressant (azathioprine, cyclosporine A, mycophenolate mofetil) and eltrombopag.
排除标准
- •Other autoimmune systemic diseases other than ITP.
- •Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia.
- •Secondary ITP.
- •Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study.
- •Use of anticoagulants or any agents that have antiplatelet effect or can affect thrombopoiesis within 3 weeks prior to the first dose of the study drug.
- •Received blood transfusion within 1 week prior to the first dose of the study drug.
- •Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug.
- •Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug.
- •Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first does of the study drug.
- •Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the first does of the study drug.
研究组 & 干预措施
HBM9161 Dose A
Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
干预措施: HBM9161 Dose A
HBM9161 Dose B
Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
干预措施: HBM9161 Dose B
Placebo
Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
干预措施: Placebo
结局指标
主要结局
Proportion of patients who achieve the early response.
时间窗: 7 weeks
The primary endpoint of phase 2
次要结局
- Proportion of patients who achieve platelet count ≥ 50 × 10^9/L at least 2 times within 7 weeks.(7 weeks)