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

Immune Thrombocytopenia (ITP) Clinical Trial

Official title:
A Multicenter, Phase 2a, Open-label, Non-randomized Study Evaluating the Efficacy, Safety, and Tolerability of BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)

Clinical Trial 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

Clinical Trial Description

Study duration: - Screening period: up to 56 days - Transition period between last sutimlimab dose and first dose of BIVV020 (for participants who were previously receiving sutimlimab): 14 days, included as part of the 56-day Screening period. Treatment duration: Minimum 52 weeks. Visit frequency: - Day 1 - Day 4 - Weeks 1 to 6: Weekly - Weeks 7 to 12: Every other week - Weeks 13 to 24: Every 4 weeks - Weeks 25+: At least every 8 weeks - End of Study visit: 22 weeks after the last dose of BIVV020 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04669600
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date February 4, 2021
Completion date February 7, 2023
View Details
See also
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