Psoriasis Clinical Trial
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Summary
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).
Eligibility Criteria
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
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There are 22 Locations for this study
Glendale Arizona, 85308, United States
Los Angeles California, 90033, United States
San Diego California, 92123, United States
San Luis Obispo California, 93405, United States
Santa Monica California, 90404, United States
Danbury Connecticut, 06810, United States
Washington District of Columbia, 20037, United States
Boca Raton Florida, 33486, United States
Tampa Florida, 33624, United States
West Des Moines Iowa, 50265, United States
Overland Park Kansas, 66215, United States
Beverly Massachusetts, 01844, United States
Brighton Massachusetts, 02135, United States
Troy Michigan, 48084, United States
East Windsor New Jersey, 08520, United States
Rocky Mount North Carolina, 27804, United States
Winston-Salem North Carolina, 27104, United States
Oklahoma City Oklahoma, 73112, United States
Portland Oregon, 97223, United States
Greer South Carolina, 29650, United States
Dallas Texas, 75231, United States
Houston Texas, 77004, United States
Houston Texas, 77004, United States
East Melbourne , , Australia
Fremantle , , Australia
Hectorville , , Australia
Kogarah , , Australia
Phillip , , Australia
Woolloongabba , , Australia
Calgary , , Canada
Mississauga , , Canada
Montréal , , Canada
Peterborough , , Canada
Toronto , , Canada
Toronto , , Canada
Waterloo , , Canada
Windsor , , Canada
Windsor , , Canada
Winnipeg , , Canada
Berlin , , Germany
Bonn , , Germany
Dresden , , Germany
Hamburg , , Germany
Hamburg , , Germany
Lubeck , , Germany
Mahlow , , Germany
Osnabrück , , Germany
Schweinfurt , , Germany
Budapest , , Hungary
Budapest , , Hungary
Budapest , , Hungary
Debrecen , , Hungary
Gyula , , Hungary
Szeged , , Hungary
Gwangju , , Korea, Republic of
Seoul , , Korea, Republic of
Białystok , , Poland
Białystok , , Poland
Bydgoszcz , , Poland
Gdańsk , , Poland
Katowice , , Poland
Katowice , , Poland
Kraków , , Poland
Lublin , , Poland
Nowa Sól , , Poland
Szczecin , , Poland
Warszawa , , Poland
Wrocław , , Poland
Wrocław , , Poland
Wrocław , , Poland
Łódź , , Poland
Łódź , , Poland
Saint Petersburg , , Russian Federation
Saratov , , Russian Federation
Yaroslavl , , Russian Federation
Taipei , , Taiwan
Taipei , , Taiwan
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