Status:
RECRUITING
A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Lead Sponsor:
Takeda
Conditions:
Immune Thrombocytopenic Purpura (ITP)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 i...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- 1\. The participant has completed TAK-079-3002 (end of trial \[EOT\]) or TAK-079-1004 (EOT).
- Key Exclusion criteria:
- For TAK-079-3002 participants:
- 1\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.
- For TAK-079-1004 participants:
- The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
- The participant has had a splenectomy within 3 months before signing the ICF.
- The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.
- In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
- The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months 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.
- The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1.
- The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.
- The participant has used anticoagulants (for example, vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to Visit 1.
- 10 The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.
- 11\. The participant has used the following immunosuppressive agents as specified prior to Visit 1: alkylating agents (for example, cyclophosphamide) within 8 weeks, vinca alkaloids (for example, vincristine) within 4 weeks, sulfones (for example, dapsone) within 3 weeks, antiproliferative agents: (for example, mycophenolate mofetil and azathioprine) within 2 weeks, and calcineurin inhibitors: (for example, cyclosporine) within 2 weeks.
- 12\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.
- Other protocol defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
August 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 29 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06948318
Start Date
August 14 2025
End Date
July 29 2029
Last Update
December 18 2025
Active Locations (96)
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1
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, California, United States, 90033
2
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
3
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
4
Emory University
Atlanta, Georgia, United States, 30308