CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
SAR445088 (BIVV020)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04669600
NCT04669600Phase 2Completed
CompareCT.gov

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)

Bioverativ, a Sanofi company·interventional·Posted Dec 17, 2020·Updated Sep 10, 2025

In Brief

A Phase 2 clinical trial evaluating SAR445088 (BIVV020) for Immune Thrombocytopenia (ITP). Completed, enrolled 12 participants across 9 sites in 6 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenia (ITP)
CountriesCzechia, Germany, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartFeb 4, 2021
Primary CompletionFeb 15, 2022
Study CompletionFeb 7, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.5 years ago

Interventions

SAR445088 (BIVV020)drug

Pharmaceutical form:solution for injection