Trial · NCT04051944

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

NCT04051944, Phase 2, Completed, UCB Biopharma SRL; results first posted 2022-11-03

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Trials, record NCT04051944. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04051944

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Trial

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

Title: A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT number: NCT04051944
Status: Completed
Phases: Phase 2
Enrollment: 21 participants, actual
Lead sponsor: UCB Biopharma SRL
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Interventions: Rozanolixizumab
First posted: 2019-08-09
Last updated: 2022-11-03
Other registries' IDs: eudract:2018-004392-12
Results first posted: 2022-11-03

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-emergent Adverse Event (TEAEs)	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 unresolved event already present before the first administration of IMP in CIDP04 study that worsened in intensity following exposure to treatment until 8 weeks following the last administration of IMP in CIDP04 study.

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	Number of Participants With Treatment-emergent Adverse Event (TEAEs)	From Baseline until Follow-Up Visit (up to Week 84)	The Safety Set (SS) consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04.	Participants	COUNT_OF_PARTICIPANTS

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
Number of Participants With Treatment-emergent Adverse Event (TEAEs)	Rozanolixizumab (Newly Treated)		10		Participants
Number of Participants With Treatment-emergent Adverse Event (TEAEs)	Rozanolixizumab (Previously Treated)		10		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Rozanolixizumab (Newly Treated)	11
Overall Study	STARTED	Rozanolixizumab (Previously Treated)	10
Overall Study	COMPLETED	Rozanolixizumab (Newly Treated)	3
Overall Study	COMPLETED	Rozanolixizumab (Previously Treated)	6
Overall Study	NOT COMPLETED	Rozanolixizumab (Newly Treated)	8
Overall Study	NOT COMPLETED	Rozanolixizumab (Previously Treated)	4

Source ClinicalTrials.gov

Adverse events50

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	Rozanolixizumab (Newly Treated)	1	11	2
other	Diarrhoea	Gastrointestinal disorders	Rozanolixizumab (Previously Treated)	1	10	1
other	Constipation	Gastrointestinal disorders	Rozanolixizumab (Newly Treated)	0	11	0
other	Constipation	Gastrointestinal disorders	Rozanolixizumab (Previously Treated)	2	10	2
other	Fatigue	General disorders	Rozanolixizumab (Newly Treated)	3	11	3
other	Fatigue	General disorders	Rozanolixizumab (Previously Treated)	3	10	4
other	Pyrexia	General disorders	Rozanolixizumab (Newly Treated)	2	11	2
other	Pyrexia	General disorders	Rozanolixizumab (Previously Treated)	0	10	0
other	Peripheral swelling	General disorders	Rozanolixizumab (Newly Treated)	1	11	1
other	Peripheral swelling	General disorders	Rozanolixizumab (Previously Treated)	1	10	1

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rozanolixizumab (Newly Treated)	0	11
Total, all-cause mortality	Rozanolixizumab (Previously Treated)	0	10
Total, other adverse events	Rozanolixizumab (Newly Treated)	10	11
Total, other adverse events	Rozanolixizumab (Previously Treated)	9	10
Total, serious adverse events	Rozanolixizumab (Newly Treated)	2	11
Total, serious adverse events	Rozanolixizumab (Previously Treated)	2	10

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 comparisons3

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

Comparison	Source
Rozanolixizumab (Newly Treated) vs Rozanolixizumab (Previously Treated): Number of Participants With Treatment-emergent Adverse Event (TEAEs)	Trial comparisons
Rozanolixizumab (Newly Treated) vs Rozanolixizumab (Previously Treated): deaths from any cause	Trial comparisons
Rozanolixizumab (Newly Treated) vs Rozanolixizumab (Previously Treated): 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/NCT04051944

GET https://conductscience.org/api/trials/v1/NCT04051944/events?page=2

API reference For AI assistants