NCT03861481

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

A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Interventions

Type	Name	Description
DRUG	Rozanolixizumab	Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
OTHER	Placebo	Subjects will receive placebo in a specified sequence during the treatment period.

Timeline

• Start date: 2019-03-26
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2019-03-04
• Last updated: 2023-08-01
• Results posted: 2022-04-04

Locations

22 sites across 8 countries: United States, Belgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study