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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time. Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met. During the study, participants will visit their study clinic several times.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. The participant has completed TAK-079-3002 (end of trial \[EOT\]) or TAK-079-1004 (EOT).

Locations
Other Locations
China
Jinshan Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-08-14
Estimated Completion Date: 2029-07-29
Participants
Target number of participants: 150
Treatments
Experimental: Mezagitamab
Eligible participants who completed the TAK-079-3002 or TAK-079-1004 studies can receive on-demand treatment in this continuation study. The on-demand treatment course may be repeated as needed based on the pre-specified on-demand dosing criteria and investigator's clinical judgement.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov