Psoriasis Clinical Trial
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Summary
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).
Eligibility Criteria
Inclusion Criteria:
An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
Subject is male or female at least 18 years of age
Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion Criteria:
Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO)
Subject has an active infection or a history of recent serious infections
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 a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
Subject had acute anterior uveitis within 6 weeks of Baseline
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
Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
Presence of active suicidal ideation, or moderately severe major depression or severe major depression
Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
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There are 25 Locations for this study
Phoenix Arizona, 85037, United States
San Diego California, 92025, United States
Tustin California, 92780, United States
Palm Harbor Florida, 34684, United States
Tampa Florida, 33613, United States
Atlanta Georgia, 30342, United States
Lexington Kentucky, 40504, United States
Hagerstown Maryland, 21742, United States
Saint Louis Missouri, 63141, United States
Albuquerque New Mexico, 87102, United States
Brooklyn New York, 11201, United States
Charlotte North Carolina, 28210, United States
Dayton Ohio, 45417, United States
Duncansville Pennsylvania, 16635, United States
Wyomissing Pennsylvania, 19610, United States
Johnston Rhode Island, 02919, United States
Orangeburg South Carolina, 29118, United States
Jackson Tennessee, 38305, United States
Memphis Tennessee, 38119, United States
Austin Texas, 78731, United States
Corpus Christi Texas, 78404, United States
Houston Texas, 77034, United States
Mesquite Texas, 75150, United States
Waco Texas, 76710, United States
Beckley West Virginia, 25801, United States
Camberwell , , Australia
Clayton , , Australia
Hobart , , Australia
Maroochydore , , Australia
Victoria Park , , Australia
Woodville , , Australia
Genk , , Belgium
Leuven , , Belgium
Mons , , Belgium
Québec City , , Canada
Rimouski , , Canada
Sidney , , Canada
Trois-Rivières , , Canada
Brno , , Czechia
Brno , , Czechia
Ostrava , , Czechia
Pardubice , , Czechia
Praha 11 , , Czechia
Praha 2 , , Czechia
Praha 4 , , Czechia
Praha 5 , , Czechia
Praha , , Czechia
Uherské Hradiště , , Czechia
Zlín , , Czechia
Paris , , France
Tours , , France
Bad Doberan , , Germany
Berlin , , Germany
Berlin , , Germany
Cottbus , , Germany
Erlangen , , Germany
Frankfurt , , Germany
Hamburg , , Germany
Hamburg , , Germany
Herne , , Germany
Leipzig , , Germany
Magdeburg , , Germany
Ratingen , , Germany
Budapest , , Hungary
Budapest , , Hungary
Debrecen , , Hungary
Eger , , Hungary
Kistarcsa , , Hungary
Szentes , , Hungary
Szombathely , , Hungary
Székesfehérvár , , Hungary
Catania , , Italy
Milano , , Italy
Pisa , , Italy
Reggio Emilia , , Italy
Bunkyō-Ku , , Japan
Itabashi , , Japan
Kawachi-Nagano-shi , , Japan
Kitakyushu , , Japan
Kita , , Japan
Minato-Ku , , Japan
Nagoya , , Japan
Osaka , , Japan
Osaka , , Japan
Saitama , , Japan
Sapporo-City , , Japan
Sasebo , , Japan
Suita , , Japan
Tokyo , , Japan
Białystok , , Poland
Bydgoszcz , , Poland
Elbląg , , Poland
Elbląg , , Poland
Gdynia , , Poland
Kraków , , Poland
Kraków , , Poland
Lublin , , Poland
Nowa Sól , , Poland
Poznań , , Poland
Poznań , , Poland
Toruń , , Poland
Warszawa , , Poland
Warszawa , , Poland
Warszawa , , Poland
Warszawa , , Poland
Wrocław , , Poland
Wrocław , , Poland
Wrocław , , Poland
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Petrozavodsk , , Russian Federation
Ryazan' , , Russian Federation
Ryazan' , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saratov , , Russian Federation
Ulyanovsk , , Russian Federation
Vladimir , , Russian Federation
Yaroslavl , , Russian Federation
Yaroslavl , , Russian Federation
Coruña , , Spain
Córdoba , , Spain
Málaga , , Spain
Sabadell , , Spain
Santiago De Compostela , , Spain
Sevilla , , Spain
Sevilla , , Spain
Sevilla , , Spain
Vigo , , Spain
Leeds , , United Kingdom
Wolverhampton , , United Kingdom
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