Psoriasis Clinical Trial
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Summary
This is a study to assess the long-term safety and tolerability of bimekizumab in subjects with psoriatic arthritis
Eligibility Criteria
Inclusion Criteria:
In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
Subject completed PA0008 without meeting any withdrawal criteria
Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
Exclusion Criteria:
Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of IMP. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into PA0009
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There are 11 Locations for this study
Lexington Kentucky, 40504, United States
Hagerstown Maryland, 21502, United States
Lansing Michigan, 48910, United States
Rochester New York, 14642, United States
Portland Oregon, 97239, United States
Duncansville Pennsylvania, 16635, United States
Johnston Rhode Island, 02919, United States
Charleston South Carolina, 29406, United States
Jackson Tennessee, 38305, United States
Dallas Texas, 75231, United States
Mesquite Texas, 75150, United States
Brno , , Czechia
Olomouc , , Czechia
Praha 11 , , Czechia
Praha 4 , , Czechia
Praha , , Czechia
Zlín , , Czechia
Cologne , , Germany
Erlangen , , Germany
Hamburg , , Germany
Ratingen , , Germany
Budapest , , Hungary
Veszprém , , Hungary
Bialystok , , Poland
Elbląg , , Poland
Elbląg , , Poland
Kraków , , Poland
Poznań , , Poland
Toruń , , Poland
Warsaw , , Poland
Warsaw , , Poland
Wrocław , , Poland
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
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