NCT04428255

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Immune Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	HBM9161 Dose A	HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
DRUG	HBM9161 Dose B	HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
DRUG	Placebo	HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly

Timeline

• Start date: 2020-07-21
• Primary completion: 2021-07-17
• Completion: 2023-03-11
• First posted: 2020-06-11
• Last updated: 2021-02-10

Locations

1 site across 1 country: China