Psoriasis Clinical Trial
A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Summary
This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).
Eligibility Criteria
Inclusion Criteria:
In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria
Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
Exclusion Criteria:
Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated
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There are 32 Locations for this study
Phoenix Arizona, 85037, United States
San Diego California, 92128, United States
Palm Harbor Florida, 34684, United States
Tampa Florida, 33613, United States
Atlanta Georgia, 30342, United States
Boise Idaho, 83702, United States
Lexington Kentucky, 40504, United States
Baton Rouge Louisiana, 70836, United States
Hagerstown Maryland, 21740, United States
Wheaton Maryland, 20902, United States
Boston Massachusetts, 02115, United States
Lansing Michigan, 48911, United States
Saint Louis Missouri, 63141, United States
Freehold New Jersey, 07728, United States
Albuquerque New Mexico, 87102, United States
Brooklyn New York, 11201, United States
New York New York, 10029, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28211, United States
Salisbury North Carolina, 28144, United States
Vandalia Ohio, 45377, 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
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 South , , Australia
Genk , , Belgium
Leuven , , Belgium
Mons , , Belgium
Quebec City , , Canada
Rimouski , , Canada
Sydney , , Canada
Trois-rivieres , , Canada
Brno , , Czechia
Brno , , Czechia
Ostrava , , Czechia
Pardubice , , Czechia
Praha 11 , , Czechia
Praha 2 , , Czechia
Praha 3 , , Czechia
Praha 4 , , Czechia
Praha 5 , , Czechia
Uherske Hradiste , , Czechia
Zlin , , Czechia
Chambray Les Tours , , France
Paris , , France
Bad Doberan , , Germany
Berlin , , Germany
Cottbus , , Germany
Erlangen , , Germany
Frankfurt , , Germany
Hamburg , , Germany
Hamburg , , Germany
Herne , , Germany
Leipzig , , Germany
Ratingen , , Germany
Budapest , , Hungary
Budapest , , Hungary
Debrecen , , Hungary
Eger , , Hungary
Kistarcsa , , Hungary
Szentes , , Hungary
Székesfehérvár , , Hungary
Catania , , Italy
Milano , , Italy
Reggio Emilia , , Italy
Bunkyo-ku , , Japan
Chuo-ku , , Japan
Itabashi-ku , , Japan
Kawachinagano , , Japan
Kita-gun , , Japan
Kitakyushu , , Japan
Minato-ku , , Japan
Nagoya , , Japan
Osaka , , Japan
Osaka , , Japan
Saitama , , Japan
Sapporo , , Japan
Sasebo , , Japan
Suita , , Japan
Bialystok , , Poland
Bydgoszcz , , Poland
Elblag , , Poland
Elblag , , Poland
Gdynia , , Poland
Krakow , , Poland
Krakow , , Poland
Lublin , , Poland
Nowa Sol , , Poland
Poznan , , Poland
Poznan , , Poland
Torun , , Poland
Warszawa , , Poland
Warszawa , , Poland
Warszawa , , Poland
Warszawa , , Poland
Wroclaw , , Poland
Wroclaw , , Poland
Wroclaw , , 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
A Coruna , , Spain
Cordoba , , Spain
Málaga , , Spain
Sabadell , , Spain
Santiago de Compostela , , Spain
Sevilla , , Spain
Sevilla , , Spain
Vigo , , Spain
Oxford , , United Kingdom
Peterborough , , United Kingdom
Wolverhampton , , United Kingdom
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