Psoriasis Clinical Trial
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy
Summary
The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who have an inadequate response or are intolerant to biologic disease-modifying anti-rheumatic drugs (DMARD) therapy.
Eligibility Criteria
Key Inclusion Criteria:
Male or female participants 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)
Have a history consistent with Psoriatic Arthritis (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
Nail changes attributed to psoriasis
Have had inadequate response (lack of efficacy after ≥ 12 week duration of therapy) or intolerance to at least one and not more than 3 biologic DMARDs (bioDMARD) 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
Key Exclusion Criteria:
Prior exposure to a janus kinase (JAK) inhibitor > 2 doses
Any active / recent infection
Any chronic and / or uncontrolled medical condition that would put the individual at increased risk during study participation or circumstances which may make a individual 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 that would interfere with assessment of study parameters or increase risk to the individual 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 59 Locations for this study
Covina California, 91723, United States
DeBary Florida, 32713, United States
Miami Florida, 33015, United States
Palm Harbor Florida, 85234, United States
Decatur Georgia, 30033, United States
Lexington Kentucky, 40504, United States
Hagerstown Maryland, 21740, United States
Saint Clair Shores Michigan, 48081, United States
Eagan Minnesota, 55121, United States
Saint Louis Missouri, 63141, United States
Toms River New Jersey, 08755, United States
Charlotte North Carolina, 28204, United States
Middleburg Heights Ohio, 44130, United States
Perrysburg Ohio, 43551, United States
Duncansville Pennsylvania, 16635, United States
Philadelphia Pennsylvania, 19152, United States
Wyomissing Pennsylvania, 19610, United States
Columbia South Carolina, 29204, United States
Orangeburg South Carolina, 29118, United States
College Station Texas, 77845, United States
Mesquite Texas, 75150, United States
South Charleston West Virginia, 25309, United States
Broadmeadow New South Wales, 2292, Australia
Maroochydore Queensland, 4558, Australia
Camberwell Victoria, 3124, Australia
Yvoir , 5530, Belgium
Quebec , G1V3M, Canada
Pardubice , 530 0, Czechia
Uherske Hradiste , 68601, Czechia
Budapest , 1036, Hungary
Gyula , 5700, Hungary
Szentes , 6600, Hungary
Hachioji-shi , 193-0, Japan
Kawachinagano , 586-8, Japan
Nagoya-City , 467-8, Japan
Nagoya , 457-8, Japan
Tokyo , 160-8, Japan
Incheon , 22332, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 07061, Korea, Republic of
Bialystok, Podlaskie , 15-09, Poland
Dabrówka , 62096, Poland
Gdansk , 80-54, Poland
Katowice , 40-04, Poland
Warsaw , 02-11, Poland
Warszawa, Mazowieckie , 02-69, Poland
Warszawa , 03-92, Poland
Wroclaw , 52-41, Poland
Fuenlabrada , 28942, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Sabadell , 8208, Spain
Santander , 39008, Spain
Sevilla , 41007, Spain
Valencia , 46010, Spain
Dailin Township , 622, Taiwan
Tainan , 71004, Taiwan
Taipei , 10507, Taiwan
Taipei , 11031, Taiwan
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