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RECRUITING Phase 3

A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

NCT06948318 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Mezagitamab

Study Locations (20)

Massachusetts

  • Massachusetts General Hospital — Boston
  • University of Massachusetts Chan Medical School — Worcester

North Carolina

  • Duke University Hospital — Durham
  • East Carolina University — Greenville

Pennsylvania

  • Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program — Philadelphia
  • Lewis Katz School of Medicine at Temple University — Philadelphia

New South Wales

  • Concord Repatriation General Hospital — Concord
  • St George Hospital — Kogarah

California

  • USC Norris Comprehensive Cancer Center - Keck Medicine of USC — Los Angeles

Colorado

  • Rocky Mountain Cancer Center — Denver

District of Columbia

  • Georgetown University Medical Center - Lombardi Comprehensive Cancer Center — Washington D.C.

Georgia

  • Emory University — Atlanta

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2025-08-14
Est. Completion 2029-07-29
Phase Phase 3

Sponsor

Takeda

387 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06948318

The ClinicalTrials.gov registry entry for NCT06948318 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Immune Thrombocytopenic Purpura (ITP) appearing as the primary indexed condition, and to 1 intervention — of which Mezagitamab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06948318 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Massachusetts, North Carolina, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06948318 about?

NCT06948318 is a clinical study titled "A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia". 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 ...

What is the current status of trial NCT06948318?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2025-08-14. Estimated completion is 2029-07-29.

What conditions does trial NCT06948318 study?

This clinical trial studies the following conditions: Immune Thrombocytopenic Purpura (ITP). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06948318?

The interventions under investigation include: Mezagitamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06948318?

This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06948318 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial