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



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:January 26, 2018
End Date:March 2020

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A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period 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 adalimumab 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 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 a known hypersensitivity to any excipients of bimekizumab or adalimumab

- Subject has an active infection (except common cold), a 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

- Subject has had previous exposure to adalimumab

- 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
23
sites
Winston-Salem, North Carolina 27104
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Beverly, Massachusetts 01915
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Boca Raton, Florida 33486
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Brighton, Massachusetts 02135
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Brighton, MA
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Dallas, Texas
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Dallas, TX
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Danbury, Connecticut 06810
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Danbury, CT
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East Melbourne,
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East Melbourne,
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East Windsor, New Jersey
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East Windsor, NJ
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Glendale, Arizona 85308
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Glendale, AZ
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Greer, South Carolina
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Greer, SC
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Houston, Texas
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Houston, TX
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708 South Barrington Avenue
Los Angeles, California 90049
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Los Angeles, CA
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Overland Park, Kansas 66215
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Overland Park, KS
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Portland, Oregon
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Portland, OR
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Rocky Mount, North Carolina 27804
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Rocky Mount, NC
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San Diego, California
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San Diego, CA
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San Luis Obispo, California
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San Luis Obispo, CA
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Santa Monica, California
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Santa Monica, 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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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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