MEZA ITP Continuation Study
Research type
Research Study
Full title
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
IRAS ID
1012386
Contact name
-- Takeda
Contact email
Sponsor organisation
Takeda Development Center Americas Inc.
Eudract number
2025-521692-31
Clinicaltrials.gov Identifier
Research summary
ITP is an autoimmune bleeding disorder that results in a decreased platelet count and may lead to bleeding events, some of which can be severe or life-threatening. Approximately 20% of patients with ITP do not respond to currently available treatments, or experience a loss of response or intolerance, resulting in increased bleeding-related morbidity and diminished quality of life. The purpose of this trial is to serve as a continuation of the phase 3 TAK-079-3002 pivotal trial and to evaluate the long-term safety, tolerability, and efficacy of mezagitamab in participants with chronic primary ITP. This trial will allow qualifying participants from the TAK-079-3002 phase 3 and TAK-079-1004 phase 2 trials to continue receiving mezagitamab as needed (“on-demand”) to treat their ITP, and provide additional safety, tolerability, and efficacy data relevant to mezagitamab use.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0234
Date of REC Opinion
19 Aug 2025
REC opinion
Further Information Favourable Opinion