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



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:June 13, 2018
End Date:August 2020
Contact:UCB Cares
Email:UCBCares@ucb.com
Phone:+1844599

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A Multicenter, Randomized, Double-Blind, Secukinumab-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 secukinumab in subjects with
moderate to severe chronic plaque psoriasis (PSO).


Inclusion Criteria:

- Male or female at least 18 years of age

- Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to
the Screening visit

- Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy

- Subject must be considered, in the opinion of the Investigator, to be a suitable
candidate for treatment with secukinumab per regional labeling and has no
contraindications to receive secukinumab as per the local label

- 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 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 severe 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
24
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Portland, Oregon
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Bexley, Ohio
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Coral Gables, Florida 33134
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Danbury, Connecticut 06810
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Forest Hills, New York 11375
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High Point, North Carolina
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Houston, Texas
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New Orleans, Louisiana 70115
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Ocala, Florida 34471
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Pembroke Pines, Florida 33028
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Pflugerville, Texas 78660
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Portsmouth, New Hampshire
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Saint Louis, Missouri
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Sandy Springs, Georgia 30329
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Santa Ana, California 92701
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Skokie, Illinois 60077
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Tampa, Florida 33624
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West des Moines, Iowa
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