A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (My CIDP choice)
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|ClinicalTrials.gov Identifier: NCT03861481|
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)||Drug: Rozanolixizumab Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||October 2020|
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) ]The Rasch-built Overall Disability Scale (iRODS) is an instrument answered by the patient to assess overall disability. Patients are asked to rate their ability to perform everyday tasks (ie, able to perform without difficulties, able to perform but with difficulties, not able to perform). The iRODS consists of 24 items. The raw sum score ranges from 0 to 48 and will be translated to log odds units (logits), placing patients' estimates on the same logit scale. For easier interpretation the person locations can be translated to values changing from 0 (most severe activity and social participation restrictions) to 100 (no activity and social participation limitations).
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
|Contact: UCB Cares||+1844599 ext 2273||UCBCares@ucb.com|
|United States, Florida|
|Tampa, Florida, United States, 33612|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28210|
|Study Director:||UCB Cares||+1 844 599 2273 (UCB)|