A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

NCT04200456 ↗

Phase 3 Terminated 33 enrolled UCB Biopharma SRL

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).

Timeline

Start: 2020-01-31
Primary completion: 2022-03-21
Completion: 2022-04-27

Outcome

Outcome not reported

Stopped (Business): “Strategic Business Decision; Not a safety decision”

Publications

Results Cooper N, Bussel JB, Kazmierczak M, Miyakawa Y, Cluck S, Lledo Garcia R, Haier B, Lavrov A, Singh P, Snipes R, Kuter DJ. Inhibition of FcRn with rozanolixizumab in adults with immune thrombocytopenia: Two randomised, double-blind, placebo-controlled phase 3 studies and their open-label extension. Br J Haematol. 2025 Feb;206(2):675-688. doi: 10.1111/bjh.19858. Epub 2024 Nov 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rozanolixizumab	Monoclonal antibody	—	Subcutaneous