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
Fremantle,
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Albuquerque, New Mexico
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Albuquerque, NM
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Alpharetta, Georgia 30022
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Bakersfield, California
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Baton Rouge, Louisiana
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Boca Raton, Florida 33486
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Boynton Beach, Florida 33437
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Coral Gables, Florida 33134
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Coral Gables, FL
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East Windsor, New Jersey
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East Windsor, NJ
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Houston, Texas
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Houston, TX
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Miami, Florida 33144
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Miami, FL
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New York, New York
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New York, NY
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Ocala, Florida 34471
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Omaha, Nebraska 68144
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Omaha, NE
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Ormond Beach, Florida
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Ormond Beach, FL
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Overland Park, Kansas 66215
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Overland Park, KS
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Phoenix, Arizona
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Phoenix, AZ
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Plainfield, Indiana 46168
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Plainfield, IN
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Portland, Oregon
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Portland, OR
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Portsmouth, New Hampshire
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Portsmouth, NH
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Saint Louis, Missouri
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Saint Louis, MO
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San Antonio, Texas
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San Antonio, TX
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San Diego, California
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San Diego, CA
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Tampa, Florida 33624
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Tampa, FL
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Troy, Michigan 48084
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Troy, MI
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West des Moines, Iowa
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West des Moines, IA
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