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

NCT06948318 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-29

No results posted yet for this 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.

Conditions

  • Immune Thrombocytopenic Purpura (ITP)

Interventions

DRUG

Mezagitamab

Mezagitamab injection administered SC.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2029-07-29
Completion
2029-07-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • China
  • Croatia
  • Hong Kong
  • Italy
  • Japan
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06948318 on ClinicalTrials.gov