Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis.



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:10/25/2018
Start Date:December 2016
End Date:September 2018

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A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a multicenter extension study to assess the long-term safety, tolerability and
efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis


Inclusion Criteria:

- Subject has provided informed consent

- Subject completes all dosing requirements in feeder study and completes PS0010 study
without meeting any withdrawal criteria

- Female subjects of childbearing potential and male subjects with a partner of
childbearing potential must continue to use an acceptable method of contraception (as
detailed in PS0010) for up to 20 weeks after the last dose of study treatment in
PS0011

Exclusion Criteria:

- Subject has previously participated in this study.

- Female subjects who plan to become pregnant during the study or within 20 weeks
following last dose of study medication. Male subjects who are planning a partner
pregnancy during the study or within 20 weeks following the last dose

- Subject has any medical or psychiatric condition that, in the opinion of the
Investigator, could jeopardize or would compromise the subject's ability to
participate in this study.

- Subject must have a negative interferon gamma release assay (IGRA) as measured at Week
8 of PS0010
We found this trial at
8
sites
708 South Barrington Avenue
Los Angeles, California 90049
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Los Angeles, CA
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Dallas, Texas
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Dallas, TX
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Edmonton,
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Edmonton,
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Houston, Texas
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Houston, TX
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Portland, Oregon
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Portland, OR
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Washington, District of Columbia
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Washington,
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West des Moines, Iowa
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West des Moines, IA
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Wilmington, North Carolina
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Wilmington, NC
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