PENGUIN 1: A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naïve to Biologic DMARD Therapy

Gilead Sciences Inc.0 个研究点目标入组 854 人2020年2月7日

适应症Psoriatic Arthritis MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859 Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Psoriatic Arthritis
发起方: Gilead Sciences Inc.
入组人数: 854
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年2月7日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Gilead Sciences Inc.

入排标准

入选标准

•Subjects must meet all of the following inclusion criteria to be eligible for participation in this
•Male or female subjects who are 18\-75 years of age (19\-75 years of age at sites in Republic of Korea. 20\-75 years of age at sites in Japan and Taiwan), on the day of signing initial informed consent
•Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and have a history consistent with PsA \=6 months at Screening
•Have active PsA defined as \=3 swollen joints (from a 66 swollen joint count \[SJC]) and \=3 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:
•Plaque psoriasis or nail changes attributed to psoriasis
•Have had inadequate response or intolerance to \=1 csDMARD, apremilast and / or NSAID, administered over the course of \=12 weeks for the treatment of PsA, as per local guidelines / standard of care
•If continuing csDMARD(s) during the study, subjects are permitted to use only a maximum of 2 of the drugs as outlined in Section 4\.2 of the Protocol and must have been on this treatment for \=12 consecutive weeks prior to Screening, with a stable dose and route of administration (defined as no change in prescription) for \=4 weeks prior to Day 1
•Concomitant NSAIDs or corticosteroids are permitted as specified in Sections 4\.2 and 4\.3 of the Protocol
•Meet one of the TB screening criteria as described in Section 4\.2 of the Protocol.

排除标准

•Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
•Known hypersensitivity to the study drug, the metabolites or the formulation excipients
•Prior PsA or psoriasis treatment with a bioDMARD
•Prior exposure to a JAK inhibitor \>2 doses
•Any active / recent infection, as specified in Section 4\.3 of the Protocol
•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 the 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 16 years old
•Active autoimmune disease 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
•Presence of any extra\-articular manifestations typically associated with rheumatoid arthritis (RA), such as rheumatoid nodules, rheumatoid lung, or other signs / symptoms, as per judgement of investigator