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).

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

67

Study ID:

NCT04115748

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 74 Locations for this study

See Locations Near You

Medvin Clinical Research
Covina California, 91723, United States
Bay Area Arthritis and Osteoporosis
Brandon Florida, 33511, United States
Omega Research Debary, LLC
DeBary Florida, 32713, United States
San Marcus Research Clinic, Inc.
Miami Florida, 33015, United States
Hmd Research Llc
Orlando Florida, 32819, United States
Arthritis Center, Inc.
Palm Harbor Florida, 85234, United States
ForCare Clinical Research
Tampa Florida, 33613, United States
BayCare Medical Group, Inc.
Tampa Florida, 33614, United States
North Georgia Rheumatology Group
Lawrenceville Georgia, 30046, 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
Physician Research Collaaboration, LLCs
Lincoln Nebraska, 68516, 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
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
University Multiprofile Hospital for Active Treatment - Plovdiv AD, Department Of Rheumatology
Plovdiv , 4003, Bulgaria
Multiprofile Hospital for Active Treatment "Lyulin" EAD, Department of Rheumatology
Sofia , 1336, Bulgaria
Diagnostic consultative center 17 Sofia EOOD
Sofia , 1505, Bulgaria
"Medical center Synexus Sofia" EOOD
Sofia , 1784, Bulgaria
"Medical center SYNEXUS SOFIA" EOOD, branch Stara Zagora
Stara Zagora , 6000, Bulgaria
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Quebec , G1V3M, Canada
CCR Ostrava, s.r.o.
Ostrava , 702 0, Czechia
Synexus (DRS) - Synexus Magyarorszag Kft. Budapest
Budapest , 1036, Hungary
Synexus (DRS) - Synexus Magyarorszag Kft. Gyula
Gyula , 5700, Hungary
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
CHA Bundang Medical Center, CHA University
Seongnam , 13496, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
SMG - SNU Boramae Medical Center
Seoul , 07061, Korea, Republic of
Waikato Hospital
Hamilton WKO, 3240, New Zealand
Optimal Clinical Trials
Auckland , 1010, New Zealand
Capital & Coast District Health Board
Newtown , 6021, New Zealand
Clinical Trials Unit, Timaru Hospital
Timaru , 7910, New Zealand
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, Podlaskie , 15-09, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela
Bydgoszcz , 85-16, Poland
NSZOZ Unica CR
Dabrówka , 62096, Poland
Centrum Medyczne Pratia Gdynia
Gdynia , 81-33, Poland
Malopolskie Badania Kliniczne SP Z O O Sp. k.
Krakow , 30-34, Poland
NZOZ Lecznica MAK-MED s.c.
Nadarzyn , 05-83, Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn , 10-11, Poland
Pheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw , 02-11, Poland
ARS RHEUMATICA Sp. Z.o.o., "REUMATIKA-Centrum Reumatologii", NZOZ
Warszawa, Mazowieckie , 02-69, Poland
Medycyna Kliniczna Marzena Waszczak-Jeka
Warszawa , 00-87, Poland
Centrum Medyczne AMED Warszawa
Warszawa , 03-92, Poland
REUMATOLOG WARSZAWA Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler
Warszawa , 04-30, Poland
Centrum Medyczne Oporow
Wroclaw , 52-41, Poland
Ulitsa Delegatskaya, 20, Building 1, Ulitsa Kasatkina, 7 Moscow, Russia, 127473/129301
Moskva , 12747, Russian Federation
LLC "Biomed"
Vladimir , 60000, Russian Federation
Center for medical advice and research - PRACTICE LTD
Yaroslavl , 15000, Russian Federation
Hospital Universitario 12 de Octubre, Avenida de Cordoba s/n, Rheumatology Service, Madrid, Spain, 28041
Madrid , 28041, Spain
Corporacio Sanitaria Parc Tauli
Sabadell , 8208, Spain
Hospital Universitario Marques de Valdecilla, Rheumatology Service, Avda. Valdecilla s/n, Santander, Cantabria, 39008
Santander , 39008, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41007, Spain
Buddhist Dalin Tzu Chi Hospital
Dailin Township , 622, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , 833, Taiwan
Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital
Keelung , 204, Taiwan
Far Eastern Memorial Hospital
New Taipei City , 220, Taiwan
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
Chi Mei Medical Center
Tainan , 71004, 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:

67

Study ID:

NCT04115748

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider