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
Troy, Michigan 48084
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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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Dallas, Texas
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Danbury, Connecticut 06810
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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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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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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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Winston-Salem, North Carolina 27104
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Winston-Salem, NC
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