A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Immune Thrombocytopenic Purpura (ITP)
In brief
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).
Key facts
- Study ID
- NCT06722235
- Run by
- Takeda
- People needed
- 171
- Starts
- 2025-02-27
- Expected to finish
- 2028-03-16
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Concord Repatriation General Hospital — Concord, New South Wales, Australia (enrolling)
- The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
- Canberra Hospital — Garran, Australian Capital Territory, Australia (enrolling)
- Georgetown University Medical Center - Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
- St George Hospital — Kogarah, New South Wales, Australia (enrolling)
- Monash University - Australian Centre for Blood Diseases (ACBD) — Melbourne, Victoria, Australia (enrolling)
- The University of Iowa — Iowa City, Iowa, United States (enrolling)
- USC Norris Comprehensive Cancer Center - Keck Medicine of USC — Los Angeles, California, United States (enrolling)
- American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- MidAmerica Cancer Center — Kansas City, Missouri, United States (enrolling)
- University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre — Liverpool, New South Wales, Australia (enrolling)
- Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
- Duke University Hospital — Durham, North Carolina, United States (enrolling)
- East Carolina University — Greenville, North Carolina, United States (enrolling)
- University Of Louisville Brown Cancer Center — Louisville, Kentucky, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program — Philadelphia, Pennsylvania, United States (enrolling)
- Lewis Katz School of Medicine at Temple University — Philadelphia, Pennsylvania, United States (enrolling)
- Baylor College of Medicine — Houston, Texas, United States (enrolling)
- Virginia Oncology Associates — Norfolk, Virginia, United States (enrolling)
- University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (enrolling)
- Versiti Wisconsin, Inc — Milwaukee, Wisconsin, United States (enrolling)
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia (enrolling)
Full record on ClinicalTrials.gov
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