A Phase 3, Randomized, Double blind, Placebo controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy

Gilead Sciences, K.K.0 个研究点目标入组 390 人开始时间: 2020年3月3日最近更新: 2023年10月17日

适应症

试验速览

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•Male or female participants who are 18-75 years of age (20-75 years of age at sites in Japan), on the day of signing initial informed consent
•-Meet Classification Criteria for Psoriatic Arthritis (CASPAR)
•-Have a history consistent with PsA 6 months or more at Screening Have active PsA defined as 3 or more swollen joints (from a 66 swollen joint count [SJC]) and 3 or more tender joints (from a 68 tender joint count [TJC]) at Screening and Day 1; these may or may not be the same joints at Screening and Day 1
•-Must have a documented history or active signs of at least one of the following at Screening
•a)Plaque psoriasis
•b)Nail changes attributed to psoriasis
•-Have had inadequate response (lack of efficacy after 12 weeks or more duration of therapy) or intolerance to at least one and not more than 3 bioDMARDs administered for the treatment of PsA or psoriasis, as per local guidelines / standard of care
•-Prior to the first dose of study drug on Day 1, treatment with bioDMARD(s) should have been discontinued

•-Prior exposure to a JAK inhibitor > 2 doses
•-Any active / recent infection
•-Any chronic and / or uncontrolled medical condition that would put the subject at increased risk during study participation or circumstances which may make a subject unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement
•-Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of investigator
•NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA
•-Any history of an inflammatory arthropathy with onset before age of 16 years old
•-Active autoimmune disease other than those listed above, that would interfere with assessment of study parameters or increase risk to the subject by participating in the study, (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis,
•transverse myelitis), per judgement of investigator
•-Pregnancy or nursing females
•Active drug or alcohol abuse, as per judgement of investigator

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