MedTrace Logo

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

NCT04669600 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-10

Study results available
· View outcomes & findings →

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

Conditions

  • Immune Thrombocytopenia (ITP)

Interventions

DRUG

SAR445088 (BIVV020)

Pharmaceutical form:solution for injection

Sponsors & Collaborators

  • Bioverativ, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-04
Primary Completion
2022-02-15
Completion
2023-02-07
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04669600 on ClinicalTrials.gov