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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

106

Study ID:

NCT04115839

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 59 Locations for this study

See Locations Near You

Medvin Clinical Research
Covina California, 91723, United States
Omega Research Debary, LLC
DeBary Florida, 32713, United States
San Marcus Research Clinic, Inc.
Miami Florida, 33015, United States
Arthritis Center, Inc.
Palm Harbor Florida, 85234, United States
Jefrey D. Lieberman, ND, P.C.
Decatur Georgia, 30033, United States
Bluegrass Community Research, Inc.
Lexington Kentucky, 40504, United States
Klein & Associates, M.D., P.A.
Hagerstown Maryland, 21740, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores Michigan, 48081, United States
St. Paul Rheumatology, P.A.
Eagan Minnesota, 55121, United States
Arthritis Consultants, Inc.
Saint Louis Missouri, 63141, United States
Atlantic Coast Research
Toms River New Jersey, 08755, United States
Joint and Muscle Research Institute
Charlotte North Carolina, 28204, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights Ohio, 44130, United States
Clinical Research Source Inc
Perrysburg Ohio, 43551, United States
Altoona Center for Clinical Research
Duncansville Pennsylvania, 16635, United States
Arthritis Group, PC
Philadelphia Pennsylvania, 19152, United States
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing Pennsylvania, 19610, United States
Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA
Columbia South Carolina, 29204, United States
ACME Research, LLC
Orangeburg South Carolina, 29118, United States
Arthritis & Osteoporosis Clinic of Brazos Valley (Drug Shipment Address)
College Station Texas, 77845, United States
Southwest Rheumatology Research, LLC
Mesquite Texas, 75150, United States
West Virginia Research Institute PLLC
South Charleston West Virginia, 25309, United States
Genesis Research Services
Broadmeadow New South Wales, 2292, Australia
Rheumatology Research Unit
Maroochydore Queensland, 4558, Australia
Emeritus Research
Camberwell Victoria, 3124, Australia
CHU UCL Namur - Site Godinne
Yvoir , 5530, Belgium
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Quebec , G1V3M, Canada
CCR Czech a.s.
Pardubice , 530 0, Czechia
Reumatologie a Osteologie MEDICAL PLUS s.r.o., Rezidence Hradebni, Obchodni 1507, Uherske Hradiste, 68601
Uherske Hradiste , 68601, Czechia
Obudai Egeszsegugyi Centrum Kft.
Budapest , 1036, Hungary
Bekes Megeyi Kozponti Korhaz, Reumatologiai Osztaly
Gyula , 5700, Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly
Szentes , 6600, Hungary
Tokyo Medical University Hachioji Medical Center
Hachioji-shi , 193-0, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachinagano , 586-8, Japan
Nagoya City University Hospital
Nagoya-City , 467-8, Japan
Daido Clinic
Nagoya , 457-8, Japan
Keio University Hospital
Tokyo , 160-8, Japan
Inha University Hospital
Incheon , 22332, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
SMG - SNU Boramae Medical Center
Seoul , 07061, Korea, Republic of
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, Podlaskie , 15-09, Poland
NSZOZ Unica CR
Dabrówka , 62096, Poland
Centrum Badan Klinicznych PI-House sp. z o.o
Gdansk , 80-54, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice , 40-04, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw , 02-11, Poland
ARS RHEUMATICA Sp. Z.o.o.
Warszawa, Mazowieckie , 02-69, Poland
Centrum Medyczne AMED Warszawa Targowek
Warszawa , 03-92, Poland
Centrum Medyczne Oporow
Wroclaw , 52-41, Poland
Hospital Universitario de Fuenlabrada - Rheumatology Department, Camino Del Molino no 2, Fuenlabrada, Madrid, 28942
Fuenlabrada , 28942, Spain
Hospital Universitario 12 de Octubre, Avenida de Cordoba, s/n, Madrid, Spain, 28041
Madrid , 28041, Spain
Hospital Universitario La Paz. Paseo de la Castellana 261, Madrid, 28046
Madrid , 28046, Spain
Corporacio Sanitaria Parc Tauli, Parc Tauli 1, Rheumatology Service, Sabadell, Barcelona, 08208
Sabadell , 8208, Spain
Hospital Universitario Marques de Valdecilla, Rheumatology Service, Avda. Valdecilla s/n, 39008
Santander , 39008, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41007, Spain
Hospital Clinico Universitario de Valencia, Avenida Blasco Ibáñez, 17 Rheumatology Service, Valencia, Spain,
Valencia , 46010, Spain
Buddhist Dalin Tzu Chi Hospital
Dailin Township , 622, Taiwan
Chi Mei Medical Center
Tainan , 71004, Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taipei , 10507, Taiwan
Taipei Medical University Hospital
Taipei , 11031, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

106

Study ID:

NCT04115839

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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