A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (MyCIDPchoice)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03861481|
Recruitment Status : Completed
First Posted : March 4, 2019
Results First Posted : April 4, 2022
Last Update Posted : May 23, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)||Drug: Rozanolixizumab Other: Placebo||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Actual Study Start Date :||March 26, 2019|
|Actual Primary Completion Date :||March 31, 2021|
|Actual Study Completion Date :||March 31, 2021|
Subjects will be randomized to receive predefined subcutaneous doses of rozanolixizumab at a specified frequency
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Placebo Comparator: Placebo
Subjects will be randomized to receive predefined subcutaneous doses of placebo at a specified frequency
Subjects will receive placebo in a specified sequence during the treatment period.
- Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861481
|Study Director:||UCB Cares||+1 844 599 2273 (UCB)|