A Study to Assess the Safety, Tolerability and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:September 5, 2018
End Date:May 2021
Contact:UCB Cares
Email:UCBCares@ucb.com
Phone:+1844599

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A Multicenter, Open-Label 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 study to evaluate the long-term safety and tolerability of bimekizumab in adult
subjects with moderate to severe chronic plaque psoriasis (PSO).


Inclusion Criteria:

- Subject is considered reliable and capable of adhering to the protocol (eg, able to
understand and complete diaries), visit schedule, and medication intake according to
the judgment of the Investigator

- Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013
[NCT03410992]) without meeting any withdrawal criteria

- Female subjects of childbearing potential must continue to use an acceptable method of
contraception (as detailed in the feeder study) for up to 20 weeks after the last dose
of bimekizumab in PS0014

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

- 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. Note: For any subject with an ongoing Serious Adverse Event
(SAE), or a history of serious infections in the feeder study, the Medical Monitor
must be consulted prior to the subject's entry into PS0014

- Subject must have a negative interferon gamma release assay (IGRA) as measured at the
final dosing visit of the feeder study

- Subject may not participate in another study of a medicinal product or device under
investigation other than the substudy

- Subject has a history of chronic alcohol or drug abuse within 6 months prior to
Baseline as assessed by medical history, site interview, and/or results of the
specified urine drug screen
We found this trial at
20
sites
San Antonio, Texas
1138
mi
from 43215
San Antonio, TX
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Bakersfield, California
1980
mi
from 43215
Bakersfield, CA
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Beverly, Massachusetts 01915
656
mi
from 43215
Beverly, MA
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Boca Raton, Florida 33486
955
mi
from 43215
Boca Raton, FL
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Buffalo, New York
294
mi
from 43215
Buffalo, NY
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Carlton,
?
mi
from 43215
Carlton,
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Forest Hills, New York 11375
485
mi
from 43215
Forest Hills, NY
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Fort Myers, Florida 33912
924
mi
from 43215
Fort Myers, FL
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Houston, Texas
991
mi
from 43215
Houston, TX
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New Orleans, Louisiana 70115
800
mi
from 43215
New Orleans, LA
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Newington, New Hampshire 03801
?
mi
from 43215
Newington, NH
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Ocala, Florida 34471
748
mi
from 43215
Ocala, FL
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Overland Park, Kansas 66215
624
mi
from 43215
Overland Park, KS
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Owensboro, Kentucky 42303
267
mi
from 43215
Owensboro, KY
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Portland, Oregon
2026
mi
from 43215
Portland, OR
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San Diego, California
1951
mi
from 43215
San Diego, CA
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Santa Monica, California
1986
mi
from 43215
Santa Monica, CA
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Skokie, Illinois 60077
285
mi
from 43215
Skokie, IL
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Verona, New Jersey
465
mi
from 43215
Verona, NJ
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West des Moines, Iowa
569
mi
from 43215
West des Moines, IA
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