A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
CompletedPhase 2Results postedLast updated 1 August 2023
What this trial tests
Phase 2 trial testing Rozanolixizumab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in 34 participants. Completed in 31 March 2021.
18 and older, any sex, with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) ScorePrimary· From Baseline up to Week 13 (Day 85)
iRODS is a linearly weighted patient-reported outcome measure (questionnaire) that captures activity and social participation limitations in participants with chronic inflammatory demyelinating polyradiculoneuropathy. Questionnaire consisted of 24 items (including eating, taking a shower, walking a flight of stairs, standing for hours, etc.) and assesses a participant's ability to perform daily and social activities. Participants had 3 response options: 0=impossible to perform; 1=performed with difficulty; 2=easily performed, performed without difficulty. Raw sum scores of iRODS (range 0 to 48
Group
Value
95% CI
Placebo
0.234
± 0.379
Rozanolixizumab
0.181
± 0.468
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline until the Safety Follow-up Visit (up to Week 24).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07465289 — A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gr
· Phase 3
· not yet recruiting
NCT07463521 — A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
· Phase 3
· not yet recruiting
NCT07246564 — Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myastheni
· Phase 4
· recruiting
NCT06720714 — A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
· Phase 1
· completed
NCT05681715 — A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Gen
· Phase 3
· completed
Other recruiting trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Currently open trials in the same condition.
NCT06798012 — A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
· Phase 2
· recruiting
NCT06747351 — A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
· Phase 3
· recruiting
NCT06538064 — A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Ca
· recruiting
NCT05084053 — A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Mu
· Phase 3
· active not recruiting
Other UCB Biopharma S.P.R.L. trials
Trials by the same sponsor.
NCT04136444 — A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function
· Phase 1
· terminated
NCT04126343 — A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants
· Phase 1
· terminated
NCT04075409 — A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants
· Phase 1
· completed
NCT04039919 — A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participan
· Phase 1
· terminated
NCT04013191 — A Study to Test the Safety and Tolerability of Single and Multiple Doses of Padsevonil in Adult and Elderly Study Partic
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Biopharma S.P.R.L.
Last refreshed: 1 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03861481.