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A Follow-up Study of Mezagitamab in Adults with Chronic Primary Immune Thrombocytopenia
EU CTIS ID: 2025-521692-31-00
What this study is testing
Safety: To evaluate the long-term safety and tolerability of mezagitamab in participants ≥18 years of age with chronic primary ITP.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. The participant has completed TAK-079-3002 (EOT) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to mezagitamab as demonstrated by meeting the criteria for “platelet response” specified for that trial during either the main study or open-label extension.
- 2. The participant has provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any trial procedures.
You likely can't join if
- 1. Key Exclusion criteria for TAK-079-3002 participants: The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.
- 2. Key Exclusion criteria for TAK-079-1004 participants: The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
- 3. The participant has had a splenectomy within 3 months before signing the ICF.
- 4. The participant has received anti-CD20 treatment within 12months before screening and either of the following applies: • The last dose was received within 6 months before screening. • The last dose was received between 6 and 12 months before screening and the participant has a CD19+ count below the lower limit of normal.
- 5. The participant has received any monoclonal/polyclonal antibody for immunomodulation within 6 months before Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
- Hong Kong
- Korea, Republic of
- Australia
- China
- Turkey
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United Kingdom; Hong Kong; Korea, Republic of; Australia; China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.