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NCT06948318 · ClinicalTrials.gov registry record · Phase 3
A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
A Phase 3 study of Immune Thrombocytopenic Purpura (ITP), sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06948318: Recruiting Phase 3 study of Immune Thrombocytopenic Purpura (ITP), sponsored by Takeda.
NCT06948318 is a Phase 3 study of Immune Thrombocytopenic Purpura (ITP) that is actively recruiting participants, run by Takeda. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06948318, a Phase 3 study of Immune Thrombocytopenic Purpura (ITP), is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or fol
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-08-14 |
| Est. Completion | 2029-07-29 |
| Phase | Phase 3 |
What NCT06948318 shows while recruiting
NCT06948318 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
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.
NCT06948318 names 20 study sites across 16 states, led by Massachusetts, North Carolina, Pennsylvania.
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).
What interventions are being tested in trial NCT06948318?
The interventions under investigation include: Mezagitamab (DRUG).
Who is sponsoring clinical trial NCT06948318?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06948318's enrollment target sits among peer trials
150 1520th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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