A Phase 2 Randomized Trial of Mezagitamab in Primary Immune Thrombocytopenia

New England Journal of Medicine 2026

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Authors: David J. Kuter, Katsuhiro Miura, Andrea Patriarca, Dražen Pulanić, Atanas Radinoff, Katya Sapunarova, Antonia Syrigou, Renchi Yang, Van Anh Nguyen, Emily Skelton, Scarlett Wang, Donald L. Yee
+1 more Parth Patwari
DOI: 10.1056/nejmoa2513120
Cited by: 3
References: 27

Abstract

BACKGROUND: Immune thrombocytopenia (ITP) is a disorder of increased platelet destruction and reduced platelet production and is associated with an increased bleeding risk and a compromised quality of life. Available therapies are ineffective in at least 20% of cases. Mezagitamab is an anti-CD38 antibody that targets plasma cells, plasmablasts, and natural killer cells. METHODS: We conducted this multicenter, double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of mezagitamab at a dose of 100 mg, 300 mg, or 600 mg, as compared with placebo, administered subcutaneously once weekly for 8 weeks in adults with persistent or chronic ITP (mean platelet count on ≥2 measurements,

Fields of Study & Subjects

Platelet Disorders and Treatments Blood groups and transfusion Heparin-Induced Thrombocytopenia and Thrombosis

Publication details

Journal / source
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Volume
394
Issue
14
Pages
1388–1398
Publication date
8 April 2026
Language
EN