Overview

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion

Status:
Active, not recruiting

Trial end date:
2021-12-01

Target enrollment:

Participant gender:

Summary

The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B is to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

Phase:

Phase 3

Details

Lead Sponsor:

Bioverativ Therapeutics Inc.
Bioverativ, a Sanofi company

Treatments:

Agglutinins
Cold agglutinins