A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults with Chronic Primary Immune Thrombocytopenia (NCT06948318)

A continuation study for patients rolling over from TAK-079-3002 or TAK-079-1004 with the purpose of evaluating the long-term efficacy of mezagitamab in participants ?18 years of age with chronic primary ITP. The trial is structured to include periods of safety follow up, long term observation and on-demand dosing.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Huyen Tran

Key inclusion data

Inclusion: The participant has completed TAK-079-3002 (EOT) or TAK-079-1004 (EOT). Exclusion: Experiencing any medical condition that, in the opinion of the investigator, might interfere with participation in the trial. Required trial intervention discontinuation for an AE/SAE deemed related to trial intervention or an opportunistic infection that required hospitalization in the TAK-079-3002 trial.