Trial · NCT03861481

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

NCT03861481, Phase 2, Completed, UCB Biopharma S.P.R.L.; results first posted 2022-04-04

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Trials, record NCT03861481. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03861481

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT number: NCT03861481
Status: Completed
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: UCB Biopharma S.P.R.L.
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Interventions: Rozanolixizumab, Placebo
First posted: 2019-03-04
Last updated: 2023-08-01
Other registries' IDs: eudract:2016-002411-17
Results first posted: 2022-04-04

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score	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, where 0=worse and 48=best) were translated to log odds units (logits) scale, placing participant' estimates on same logit scale, which had a score range of -6.95 (most severe activity and social participation restrictions) to 8.11 (no activity and social participation limitations). A positive change is associated with a better outcome of less disease activity and more social activity.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score	From Baseline up to Week 13 (Day 85)	The Full Analysis Set (FAS) consisted of all participants who received at least one dose of treatment and who had a Baseline and at least one valid post-Baseline iRODS measurement up to Week 13 (Day 85)/premature end of treatment (inclusively).	score on a scale (logits)	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score	Placebo		0.234	Standard Error 0.379	score on a scale (logits)
Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score	Rozanolixizumab		0.181	Standard Error 0.468	score on a scale (logits)

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	17
Overall Study	STARTED	Rozanolixizumab	17
Overall Study	COMPLETED	Placebo	11
Overall Study	COMPLETED	Rozanolixizumab	10
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Rozanolixizumab	7

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Placebo	3	17	5
other	Diarrhoea	Gastrointestinal disorders	Rozanolixizumab	2	17	2
other	Nausea	Gastrointestinal disorders	Placebo	2	17	6
other	Nausea	Gastrointestinal disorders	Rozanolixizumab	0	17	0
other	Infusion site erythema	General disorders	Placebo	0	17	0
other	Infusion site erythema	General disorders	Rozanolixizumab	3	17	4
other	Peripheral swelling	General disorders	Placebo	0	17	0
other	Peripheral swelling	General disorders	Rozanolixizumab	3	17	3
other	Fatigue	General disorders	Placebo	3	17	3
other	Fatigue	General disorders	Rozanolixizumab	0	17	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	17
Total, all-cause mortality	Rozanolixizumab	0	17
Total, other adverse events	Placebo	14	17
Total, other adverse events	Rozanolixizumab	15	17
Total, serious adverse events	Placebo	0	17
Total, serious adverse events	Rozanolixizumab	2	17

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38729747	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Rozanolixizumab vs Placebo: deaths from any cause	Trial comparisons
Rozanolixizumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03861481

GET https://conductscience.org/api/trials/v1/NCT03861481/events?page=2

API reference For AI assistants