A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Condition(s) studied
Investigational drug(s) / intervention(s)
Mezagitamab: Mezagitamab injection administered SC.
Placebo: Mezagitamab-matching placebo injection administered SC.
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).
Eligibility
Primary outcome measure(s)
- Percentage of Participants With Durable Platelet Response — Up to Week 24
Durable platelet response is defined as platelet count greater than or equal to (≥)50,000/microliter (μL) on at least 4 of the 6 weekly platelet measurements between Weeks 19 and 24.
Trial sites (124)
| Facility | City | Region | Status |
|---|---|---|---|
| Genesis Cancer and Blood Institute - SCRI | Hot Springs | Arkansas | Recruiting |
| USC Norris Comprehensive Cancer Center - Keck Medicine of USC | Los Angeles | California | Recruiting |
| University of California San Diego Center for Bleeding and Clotting Disorders | San Diego | California | Not Yet Recruiting |
| Rocky Mountain Cancer Center | Denver | Colorado | Withdrawn |
| Georgetown University Medical Center - Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | Recruiting |
| Emory University | Atlanta | Georgia | Recruiting |
| Innovative Hematology, Inc. | Indianapolis | Indiana | Not Yet Recruiting |
| The University of Iowa | Iowa City | Iowa | Recruiting |
| University Of Louisville Brown Cancer Center | Louisville | Kentucky | Recruiting |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | Completed |
| MidAmerica Cancer Center | Kansas City | Missouri | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Not Yet Recruiting |
| Montefiore Medical Center | The Bronx | New York | Not Yet Recruiting |
| Duke University Hospital | Durham | North Carolina | Recruiting |
| East Carolina University | Greenville | North Carolina | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Not Yet Recruiting |
| Oregon Health & Science University | Portland | Oregon | Recruiting |
| Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program | Philadelphia | Pennsylvania | Recruiting |
| Lewis Katz School of Medicine at Temple University | Philadelphia | Pennsylvania | Recruiting |
| Baylor College of Medicine | Houston | Texas | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | Recruiting |
| University of Washingto | Seattle | Washington | Not Yet Recruiting |
| Versiti Wisconsin, Inc | Milwaukee | Wisconsin | Recruiting |
| Canberra Hospital | Garran | Australian Capital Territory | Recruiting |
| Concord Repatriation General Hospital | Concord | New South Wales | Recruiting |
| St George Hospital | Kogarah | New South Wales | Recruiting |
| University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre | Liverpool | New South Wales | Recruiting |
| Westmead Hospital | Westmead | New South Wales | Recruiting |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | Not Yet Recruiting |
| Monash University - Australian Centre for Blood Diseases (ACBD) | Melbourne | Victoria | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Fiona Stanley Hospital | Murdoch | Western Australia | Recruiting |
| Perth Blood Institute | West Perth | Western Australia | Recruiting |
| Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia | Sofia | Sofia-Grad | Recruiting |
| Medical Center "Fama Medical" | Plovdiv | Bulgaria | Recruiting |
| UMHAT Sv. Ivan Rilski | Sofia | Bulgaria | Recruiting |
| UMHAT SofiaMed, OOD | Sofia | Bulgaria | Recruiting |
| University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD | Stara Zagora | Bulgaria | Recruiting |
+ 84 more sites — see the full list on the official registry below.
More Takeda trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06722235 on ClinicalTrials.gov ↗ ← All trials in the UK