Psoriasis Clinical Trial
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive 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 are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).
Eligibility Criteria
Key Inclusion Criteria:
Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and 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 or intolerance to ≥1 conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), apremilast and / or NSAID, administered over the course of ≥ 12 weeks for the treatment of PsA, as per local guidelines / standard of care
Key Exclusion Criteria:
Prior PsA or psoriasis treatment with a biologic DMARD
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 an 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 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 74 Locations for this study
Covina California, 91723, United States
Brandon Florida, 33511, United States
DeBary Florida, 32713, United States
Miami Florida, 33015, United States
Orlando Florida, 32819, United States
Palm Harbor Florida, 85234, United States
Tampa Florida, 33613, United States
Tampa Florida, 33614, United States
Lawrenceville Georgia, 30046, 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
Lincoln Nebraska, 68516, 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
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
Plovdiv , 4003, Bulgaria
Sofia , 1336, Bulgaria
Sofia , 1505, Bulgaria
Sofia , 1784, Bulgaria
Stara Zagora , 6000, Bulgaria
Quebec , G1V3M, Canada
Ostrava , 702 0, Czechia
Budapest , 1036, Hungary
Gyula , 5700, Hungary
Kawachinagano , 586-8, Japan
Nagoya-City , 467-8, Japan
Nagoya , 457-8, Japan
Tokyo , 160-8, Japan
Seongnam , 13496, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 07061, Korea, Republic of
Hamilton WKO, 3240, New Zealand
Auckland , 1010, New Zealand
Newtown , 6021, New Zealand
Timaru , 7910, New Zealand
Bialystok, Podlaskie , 15-09, Poland
Bydgoszcz , 85-16, Poland
Dabrówka , 62096, Poland
Gdynia , 81-33, Poland
Krakow , 30-34, Poland
Nadarzyn , 05-83, Poland
Olsztyn , 10-11, Poland
Warsaw , 02-11, Poland
Warszawa, Mazowieckie , 02-69, Poland
Warszawa , 00-87, Poland
Warszawa , 03-92, Poland
Warszawa , 04-30, Poland
Wroclaw , 52-41, Poland
Moskva , 12747, Russian Federation
Vladimir , 60000, Russian Federation
Yaroslavl , 15000, Russian Federation
Madrid , 28041, Spain
Sabadell , 8208, Spain
Santander , 39008, Spain
Sevilla , 41007, Spain
Dailin Township , 622, Taiwan
Kaohsiung , 833, Taiwan
Keelung , 204, Taiwan
New Taipei City , 220, Taiwan
Tainan , 70403, Taiwan
Tainan , 71004, Taiwan
Taipei , 11031, Taiwan
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