A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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|ClinicalTrials.gov Identifier: NCT04051944|
Recruitment Status : Completed
First Posted : August 9, 2019
Results First Posted : November 3, 2022
Last Update Posted : November 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)||Drug: Rozanolixizumab||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 :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)|
|Actual Study Start Date :||August 21, 2019|
|Actual Primary Completion Date :||November 10, 2021|
|Actual Study Completion Date :||November 10, 2021|
Subjects in this arm will receive predefined subcutaneous doses of rozanolixizumab at a specified frequency.
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
- Number of Participants With Treatment-emergent Adverse Event (TEAEs) [ Time Frame: 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.
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): NCT04051944
|United States, Arizona|
|Scottsdale, Arizona, United States, 85251|
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28210|
|Durham, North Carolina, United States, 27710|
|Sheffield, United Kingdom|
|Study Director:||UCB Cares||001 844 599 2273 (UCB)|