A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP

Primary Immune Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428255
• Other study ID #: 9161.4
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 21, 2020
• Est. completion date: March 11, 2023

Study information

• Verified date: February 2021
• Source: Harbour BioMed (Guangzhou) Co. Ltd.
• Contact: Shuai Zhao
• Phone: +86 15901236575
• Email: peter.zhao[@]harbourbiomed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To select a dose and to make a decision for Phase 3 study

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 information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 11, 2023
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age at the screening visit, male or female.

2. 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.

3. 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.

4. 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:

1. Other autoimmune systemic diseases other than ITP.

2. Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia.

3. Secondary ITP.

4. Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study.

5. 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.

6. Received blood transfusion within 1 week prior to the first dose of the study drug.

7. Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug.

8. Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug.

9. Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first does of the study drug.

10. Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the first does of the study drug.

11. Treated with splenectomy within 4 weeks prior to first dose of the study drug.

12. Any thromboembolic or embolic events within 12 months prior to the first does of the study drug.

13. Serum total IgG < 700 mg/dL at the screening visit.

Related Conditions & MeSH terms

• Primary Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• HBM9161 Dose A
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
• HBM9161 Dose B
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
• Placebo
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly

Locations

Country	Name	City	State
China	Hematology hospital, Chinese academy of medical sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Harbour BioMed (Guangzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieve the early response.	The primary endpoint of phase 2	7 weeks
Secondary	Proportion of patients who achieve platelet count = 50 × 10^9/L at least 2 times within 7 weeks.		7 weeks