A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Phase 2 Completed 34 enrolled UCB Biopharma S.P.R.L.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

Timeline

Start: 2019-03-26
Primary completion: 2021-03-31
Completion: 2021-03-31

Outcome

Missed primary endpoint

paper No significant difference in CFB to day 85 in iRODS centile score was observed between rozanolixizumab PMID 38729747 ↗

paper Rozanolixizumab did not show efficacy in patients with CIDP in this study PMID 38729747 ↗

Publications

Querol L, De Seze J, Dysgaard T, Levine T, Rao TH, Rivner M, Hartung HP, Kiessling P, Shimizu S, Marmol D, Bozorg A, Colson AO, Massow U, Eftimov F; CIDP01 Study Investigators. Efficacy, safety and tolerability of rozanolixizumab in patients with chronic inflammatory demyelinating polyradiculoneuropathy: a randomised, subject-blind, investigator-blind, placebo-controlled, phase 2a trial and open-label extension study. J Neurol Neurosurg Psychiatry. 2024 Aug 16;95(9):845-854. doi: 10.1136/jnnp-2023-333112.

Drugs