A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
|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: NCT04051944|
Recruitment Status : Active, not recruiting
First Posted : August 9, 2019
Last Update Posted : September 17, 2021
|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|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||November 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.
- Incidence of 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 patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have 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.
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)|