This phase III trial is evaluating an investigational drug (Sutimlimab) in patients with Primary Cold Agglutinin disease, who have recently received a blood transfusion.
This trial is treating patients with primary cold agglutinin disease.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had a certain type of treatment or surgical procedure.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
Use the hyperlinks, where available to access additional clinical trial information.
Scientific Title
A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion
Commercial Sponsor
Bioverativ Therapeutics Inc.
Summary
Participants in this trial will receive intravenous sutimlimab in Part A. Participants who complete Part A through to Day 182 (end of treatment) according to the protocol will participate in Part B. Participants in Part B will continue to receive sutimlimab up to one year after last patient out (LPO) in Part A.
Recruiting Hospitals Read More
Not Recruiting Hospitals Read More