A Phase 3 Randomized Multicenter Double-Blind Placebo-Controlled Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis

Brief description of study

The purpose of the study is to evaluate the efficacy of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV subjects with AL amyloidosis. The study drug, birtamimab, is a monoclonal antibody designed to target and clear the amyloid that accumulates and causes organ dysfunction and failure in patients with AL amyloidosis. Is is an investigational agent, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01912
ClinicalTrials.gov Identifier: NCT04973137
Principal Investigator: Gareth J. Morgan.
Other Investigators: Maxim Kreditor, Marc Justin Braunstein, Faith E. Davies, Vathveal Mathews, Bonnie Kiner-Strachan, Kenneth B Hymes, Michael L. Grossbard, John Leslie Vaughn, Michael E Garrison, Danny Perlaza, Ivy Mutibura, Shella Saint Fleur-Lominy, David Kaminetzky, Tibor Moskovits, Bruce G Raphael, Thaleshravi Prashad.


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