A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab 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:3/6/2019
Start Date:February 5, 2018
End Date:January 2020

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A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of
subjects with moderate to severe chronic plaque psoriasis.


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, recurrent, or 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
19
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Owensboro, Kentucky 42303
1739
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Owensboro, KY
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Beverly, Massachusetts 01915
2588
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Beverly, MA
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Buffalo, New York
2180
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Buffalo, NY
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Carlton,
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Carlton,
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Cleveland, Ohio
2032
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Cleveland, OH
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Fort Myers, Florida 33912
2205
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Fort Myers, FL
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Johnston, Rhode Island
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Johnston, RI
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Murray, Utah 84107
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Murray, UT
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New Orleans, Louisiana 70115
1654
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New Orleans, LA
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New York, New York
2351
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New York, NY
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Portland, Oregon
828
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Portland, OR
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Portsmouth, New Hampshire
2591
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Portsmouth, NH
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Rochester, New York
2245
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Rochester, NY
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San Antonio, Texas
1188
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San Antonio, TX
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San Diego, California
106
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San Diego, CA
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Sandy Springs, Georgia 30329
1921
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Sandy Springs, GA
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Santa Monica, California
27
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Santa Monica, CA
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Skokie, Illinois 60077
1724
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Skokie, IL
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Verona, New Jersey
2420
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Verona, NJ
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