NCT04669600

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Bioverativ, a Sanofi company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	SAR445088 (BIVV020)	Pharmaceutical form:solution for injection

Timeline

• Start date: 2021-02-04
• Primary completion: 2022-02-15
• Completion: 2023-02-07
• First posted: 2020-12-17
• Last updated: 2025-09-10
• Results posted: 2024-02-22

Locations

9 sites across 6 countries: United States, Czechia, Germany, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study