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| Rocky Mountain Cancer Center | Denver | Colorado | Withdrawn |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 Spain
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 Spain