Psoriasis Clinical Trial
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
Summary
Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.
Eligibility Criteria
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
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There are 20 Locations for this study
San Diego California, 92103, United States
San Diego California, 92123, United States
Santa Monica California, 90404, United States
Fort Myers Florida, 33912, United States
Sandy Springs Georgia, 30329, United States
Skokie Illinois, 60077, United States
Owensboro Kentucky, 42303, United States
New Orleans Louisiana, 70115, United States
Beverly Massachusetts, 01915, United States
Portsmouth New Hampshire, 03801, United States
Verona New Jersey, 07044, United States
Buffalo New York, 14221, United States
New York New York, 10021, United States
New York New York, 10025, United States
Rochester New York, 14623, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97223, United States
Johnston Rhode Island, 02919, United States
San Antonio Texas, 78213, United States
Murray Utah, 84107, United States
Carlton , , Australia
East Melbourne , , Australia
Kogarah , , Australia
Ajax , , Canada
Edmonton , , Canada
Hamilton , , Canada
Markham , , Canada
Mississauga , , Canada
Montréal , , Canada
North Bay , , Canada
Ottawa , , Canada
Québec , , Canada
Surrey , , Canada
Waterloo , , Canada
Hamburg , , Germany
Hamburg , , Germany
Münster , , Germany
Schwerin , , Germany
Witten , , Germany
Budapest , , Hungary
Miskolc , , Hungary
Orosháza , , Hungary
Szeged , , Hungary
Szolnok , , Hungary
Veszprém , , Hungary
Busan , , Korea, Republic of
Seongnam-si , , Korea, Republic of
Seoul , , Korea, Republic of
Białystok , , Poland
Białystok , , Poland
Białystok , , Poland
Gdańsk , , Poland
Katowice , , Poland
Katowice , , Poland
Katowice , , Poland
Kielce , , Poland
Kraków , , Poland
Lublin , , Poland
Poznań , , Poland
Szczecin , , Poland
Warsaw , , Poland
Warsaw , , Poland
Warszawa , , Poland
Wrocław , , Poland
Wrocław , , Poland
Wrocław , , Poland
Łódź , , Poland
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saratov , , Russian Federation
Yaroslavl , , Russian Federation
Manchester , , United Kingdom
Reading , , United Kingdom
Salford , , United Kingdom
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