AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

RecruitingPhase 3Ages 18 Years - anyAllTakeda
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
* Key Inclusion Criteria: 1\. The participant has completed TAK-079-3002 (end of trial \[EOT\]) 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. * 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: 1. The participant has had any thrombotic or embolic event within 12 months before signing the ICF. 2. The participant has had a splenectomy within 3 months before signing the ICF. 3. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). 4. 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. 5. 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. 6. The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening and either of the following applies: 1. The last dose was received within 6 months before screening. 2. 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. 7. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1. 8. The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1. 9. 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.
๐Ÿ’Š

What it tests

  • Mezagitamab
๐Ÿ“

Where

118 sites
Genesis Cancer and Blood Institute - SCRI
Hot Springs, United States
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, United States
University of California San Diego Center for Bleeding and Clotting Disorders
San Diego, United States
Rocky Mountain Cancer Center
Denver, United States
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., United States
Emory University
Atlanta, United States
Innovative Hematology, Inc.
Indianapolis, United States
The University of Iowa
Iowa City, United States

โ€ฆand 110 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy