MedTrace Logo

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

NCT06722235 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2026-05-22

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 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).

Conditions

  • Immune Thrombocytopenic Purpura (ITP)

Interventions

DRUG

Mezagitamab

Mezagitamab injection administered SC.

DRUG

Placebo

Mezagitamab-matching placebo injection administered SC.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-27
Primary Completion
2028-03-16
Completion
2028-03-16
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
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 NCT06722235 on ClinicalTrials.gov