At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion
In Brief
A Phase 3 clinical trial evaluating sutimlimab (BIVV009) and placebo for Cold Agglutinin Disease. Completed, enrolled 42 participants across 53 sites in 14 countries.
Detailed Summary
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=)1.5 grams 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 was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.
Study Details
Timeline
Interventions
Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)