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A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia

NCT06722235•Takeda

View on ClinicalTrials.gov

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 low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \[SC\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. The participants will be treated with mezagitamab for up to 6 months. During the study, participants will visit their study clinic several times. Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The participant has been diagnosed with ITP that has persisted for at least 12 months.
•2. The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist \[TPO-RA\]), defined as having achieved a platelet count ≥50,000/μL.
•3. The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids), and at least 1 currently available second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000/μL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy.
•4. The participant has a mean platelet count of \<30,000/μL.
•5. If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial.
•6. If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention.

Exclusion Criteria

•1. The participant has secondary ITP.
•2. The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).
•3. The participant has had a splenectomy.
•4. The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
•5. 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.
•6. 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.
•7. 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 cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.
•8. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Day 1.
+6 more criteria

Locations (110)

USC Norris Comprehensive Cancer Center - Keck Medicine of USC

Los Angeles, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Emory University

Atlanta, Georgia, United States

The University of Iowa

Iowa City, Iowa, United States

University Of Louisville Brown Cancer Center

Louisville, Kentucky, United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Duke University Hospital

Durham, North Carolina, United States

Key Dates

Start Date

February 27, 2025

Primary Completion Date

December 28, 2027

Completion Date

December 28, 2027

Last Updated

March 6, 2026

Enrollment

171

ESTIMATED participants

Conditions

Immune Thrombocytopenic Purpura (ITP)

Interventions

Mezagitamab

DRUG

Placebo

DRUG

Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

NCT00162006

Immune Thrombocytopenic Purpura (ITP)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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