A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
CompletedPhase 2Results postedLast updated 3 November 2022
What this trial tests
Phase 2 trial testing Rozanolixizumab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in 21 participants. Completed in 10 November 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.
Number of Participants With Treatment-emergent Adverse Event (TEAEs)Primary· From Baseline until Follow-Up Visit (up to Week 84)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any event that was not present prior the first administration of investigational medicinal product (IMP) in CIDP04 study or any unr
Group
Value
95% CI
Rozanolixizumab (Newly Treated)
10
Rozanolixizumab (Previously Treated)
10
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline until Follow-Up Visit (up to Week 84).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rozanolixizumab (Newly Treated)
Serious: 2/11 (18%)
Deaths: 0/11
Rozanolixizumab (Previously Treated)
Serious: 2/10 (20%)
Deaths: 0/10
Serious adverse events (4 terms)
Reaction
System
Rozanolixizumab (Newly Tre…
Rozanolixizumab (Previousl…
Urinary tract infection
Infections and infestations
—
—
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Publications & conference data
5 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 SRL trials
Trials by the same sponsor.
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
NCT07277660 — A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Stu
· Phase 2
· recruiting
NCT07290036 — A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adu
· Phase 1
· recruiting
NCT07286682 — A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants
· Phase 1
· recruiting
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 SRL
Last refreshed: 3 November 2022
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/NCT04051944.