At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
Rozanolixizumab +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Age ≥18 years with body weight ≥42 kg at screening
- ✓Documented definite or probable CIDP diagnosis by EFNS/PNS 2010 criteria
- ✓Immunoglobulin-dependency confirmed by clinical examination during therapy or upon interruption/reduction within 18 months prior to screening
- ✓On stable dosage (±20% deviation) of subcutaneous or intravenous immunoglobulin for at least 4 months with fixed interval
Key exclusion· 10
- ✕Prior exposure to rozanolixizumab or participation in this study
- ✕Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus, or hemoglobin A1c >6.0%
- ✕Known IgM-mediated neuropathy
- ✕Clinical or known evidence of associated systemic diseases causing neuropathy or treatment with agents causing neuropathy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Rozanolixizumab and Placebo for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). Completed, enrolled 34 participants across 22 sites in 8 countries.
Detailed Summary
The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartMar 2019
Primary CompletionMar 2021
TodayJul 2026
First PostedMar 4, 2019
Enrollment StartMar 26, 2019
Primary CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.3 years ago
Interventions
Rozanolixizumabdrug
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Placeboother
Subjects will receive placebo in a specified sequence during the treatment period.