This is a Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis.
|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: NCT03230292|
Recruitment Status : Completed
First Posted : July 26, 2017
Last Update Posted : March 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Plaque Psoriasis||Drug: Bimekizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, 48-week, Open-label Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis.|
|Actual Study Start Date :||July 3, 2017|
|Actual Primary Completion Date :||March 6, 2019|
|Actual Study Completion Date :||March 6, 2019|
Experimental: Cohort 1
Subjects in this cohort will receive dose 1 every four weeks (Q4W) subcutaneously (sc) during the 48-week open-label Treatment Period. There will be an option to increase the dose to dose 2 Q4W at the discretion of the Investigator if the subject's Psoriasis Area and Severity Index (PASI) response is >=50% to <75% reduction from the Baseline of PS0016 at Week 12 or later. If the subject's disease is adequately controlled on dose 2 Q4W, they may return to dose 1 Q4W at the discretion of the Investigator.
Bimekizumab will be administered subcutaneously in 2 different doses.
Other Name: UCB4940
- Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment [ Time Frame: From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64) ]
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): NCT03230292
|United States, North Carolina|
|High Point, North Carolina, United States, 27265|
|United States, Ohio|
|Bexley, Ohio, United States, 43209|
|East Melbourne, Australia|
|Moldova, Republic of|
|Chisinau, Moldova, Republic of|
|Study Director:||UCB Cares||UCB (+1 844 599 2273)|