drugset / Trial / NCT05714969

A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

NCT05714969 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The main aim of this study is to determine the percentage of participants with a clinical (Part 1) or platelet (Part 2) response without plasma exchange during the study. Participants who have an acute attack of iTTP will receive TAK-755 and immunosuppressive therapy during their stay at the hospital until they achieve a clinical response in Part 1 or platelet response in Part 2. Participants will also be treated with TAK-755 for an additional time of up to 6 weeks after the acute phase. In total, participants will stay in the study for approximately 3 months.

Timeline

Start
2023-07-21
Primary completion
2026-04-16
Completion
2026-04-16

Drugs

EvaluationDrugModalityDoseRoute
Subject TAK-755 Protein / enzyme biologic — Intravenous