A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis



Status:Active, not recruiting
Conditions:Arthritis, Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:December 6, 2017
End Date:January 2020

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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a study to compare the efficacy of bimekizumab versus placebo and an active
comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis
(PSO).


Inclusion Criteria:

- Must be at least 18 years of age

- Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit

- Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
>=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

- Subject is a candidate for systemic PSO therapy and/or phototherapy

- Female subject of child bearing potential must be willing to use highly effective
method of contraception

Exclusion Criteria:

- Subject has an active infection (except common cold), a recent serious infection, or a
history of opportunistic or recurrent chronic infections

- Subject has concurrent acute or chronic viral hepatitis B or C or human
immunodeficiency virus (HIV) infection

- Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB
infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

- Subject has any other condition, including medical or psychiatric, which, in the
Investigator's judgment, would make the subject unsuitable for inclusion in the study

- Presence of active suicidal ideation or positive suicide behavior

- Presence of moderately severe major depression or severe major depression

- Subject has any active malignancy or history of malignancy within 5 years prior to the
Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
carcinoma, or in situ cervical cancer
We found this trial at
26
sites
Ormond Beach, Florida
746
mi
from 43215
Ormond Beach, FL
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Albuquerque, New Mexico
1333
mi
from 43215
Albuquerque, NM
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Alpharetta, Georgia 30022
412
mi
from 43215
Alpharetta, GA
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Bakersfield, California
1980
mi
from 43215
Bakersfield, CA
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Baton Rouge, Louisiana
800
mi
from 43215
Baton Rouge, LA
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Boca Raton, Florida 33486
955
mi
from 43215
Boca Raton, FL
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Boynton Beach, Florida 33437
943
mi
from 43215
Boynton Beach, FL
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Coral Gables, Florida 33134
996
mi
from 43215
Coral Gables, FL
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East Windsor, New Jersey
?
mi
from 43215
East Windsor, NJ
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Fremantle,
?
mi
from 43215
Fremantle,
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Houston, Texas
991
mi
from 43215
Houston, TX
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Miami, Florida 33144
993
mi
from 43215
Miami, FL
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New York, New York
442
mi
from 43215
New York, NY
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Ocala, Florida 34471
748
mi
from 43215
Ocala, FL
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Omaha, Nebraska 68144
?
mi
from 43215
Omaha, NE
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Overland Park, Kansas 66215
624
mi
from 43215
Overland Park, KS
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Phoenix, Arizona
1662
mi
from 43215
Phoenix, AZ
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Plainfield, Indiana 46168
?
mi
from 43215
Plainfield, IN
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Portland, Oregon
2026
mi
from 43215
Portland, OR
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Portsmouth, New Hampshire
668
mi
from 43215
Portsmouth, NH
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Saint Louis, Missouri
394
mi
from 43215
Saint Louis, MO
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San Antonio, Texas
1138
mi
from 43215
San Antonio, TX
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San Diego, California
1951
mi
from 43215
San Diego, CA
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Tampa, Florida 33624
820
mi
from 43215
Tampa, FL
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Troy, Michigan 48084
182
mi
from 43215
Troy, MI
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West des Moines, Iowa
569
mi
from 43215
West des Moines, IA
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