A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP
Phase 2
- Conditions
- Primary Immune Thrombocytopenic Purpura
- Interventions
- Drug: HBM9161 Dose ADrug: HBM9161 Dose BDrug: Placebo
- Registration Number
- NCT04428255
- Lead Sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Brief Summary
To select a dose and to make a decision for Phase 3 study
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- ≥ 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.
Exclusion Criteria
- 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.
- Treated with splenectomy within 4 weeks prior to first dose of the study drug.
- Any thromboembolic or embolic events within 12 months prior to the first does of the study drug.
- Serum total IgG < 700 mg/dL at the screening visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HBM9161 Dose A HBM9161 Dose A Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo HBM9161 Dose B HBM9161 Dose B Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo Placebo Placebo Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
- Primary Outcome Measures
Name Time Method Proportion of patients who achieve the early response. 7 weeks The primary endpoint of phase 2
- Secondary Outcome Measures
Name Time Method Proportion of patients who achieve platelet count ≥ 50 × 10^9/L at least 2 times within 7 weeks. 7 weeks
Trial Locations
- Locations (1)
Hematology hospital, Chinese academy of medical sciences
🇨🇳Tianjin, Tianjin, China