drugset / Trial / NCT04669600

A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)

NCT04669600

Phase 2 Completed 12 enrolled Bioverativ, a Sanofi company
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: \- To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: * To assess the safety and tolerability of BIVV020 * To assess the pharmacokinetics of BIVV020 * To assess the response rate of treatment with BIVV020 * To assess the time to response * To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy * To assess the immunogenicity of BIVV020

Timeline

Start
2021-02-04
Primary completion
2022-02-15
Completion
2023-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Riliprubart Monoclonal antibody