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
Parth Patwari
Contact email
Sponsor organisation
Takeda Development Center Americas Inc.
Eudract number
2025-521692-31
ISRCTN Number
-
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