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drugset / Trial / NCT05653349

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

NCT05653349 ↗

Phase 3 Active not recruiting 226 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in increasing the rate of stable response off treatment at 12 months (SROT-12) in adult participants with primary ITP.

Timeline

Start
2023-02-03
Primary completion
2026-10-29
Completion
2029-01-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ianalumab Monoclonal antibody — Intravenous

Indications

primary thrombocytopenia