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A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

StatusRecruiting
PhasePhase 3
SponsorTakeda
Started2025-02-27
View on ClinicalTrials.gov ↗
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).

Amendment history 3 changes detected by DataLookout

2026-08-08
minor
Trial sites expanded: 114 → 123 locations
2026-05-23
notable
Primary completion pushed: 2027-12-28 → 2028-03-16
2026-05-23
minor
Completion pushed: 2027-12-28 → 2028-03-16
Trial Details
NCT Number NCT06722235
Lead Sponsor Takeda
Conditions Immune Thrombocytopenic Purpura (ITP)
Enrollment 171 participants
Start Date 2025-02-27
Primary Completion 2028-03-16 (estimated)
Study Completion 2028-03-16 (estimated)
Updated on ClinicalTrials.gov 2026-08-07