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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
Bioverativ Therapeutics Inc.
This is a randomised, double blind, placebo controlled study. In Part A of this study, participants will be randomised to receive either sutimlimab or placebo via intravenous administration. In Part B, all participants will undergo blinded cross-over loading doses. This will allow all participants to receive sutimlimab, while maintaining Part A blinding.