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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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 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.

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 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 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 subject 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04115839
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Gilead Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gilead Study Director
Principal Investigator Affiliation Gilead Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, Czechia, Hungary, Japan, Korea, Republic of, Poland, Spain, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: Filgotinib 200 mg (Main Study)

Participants will receive filgotinib 200 mg + placebo to match (PTM) filgotinib 100 mg for up to 16 weeks.

Experimental: Filgotinib 100 mg (Main Study)

Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 16 weeks.

Placebo Comparator: Placebo (Main Study)

Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg for up to 16 weeks.

Experimental: Filgotinib 200 mg (LTE)

Participants will receive filgotinib 200 mg + PTM filgotinib 100 mg for up to 2 years.

Experimental: Filgotinib 100 mg (LTE)

Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 2 years.

Interventions

Drug: - Filgotinib

Tablets will be administered orally once daily with or without food.

Drug: - Placebo to match filgotinib

Tablets administered orally once daily with or without food.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Medvin Clinical Research, Covina, California

Status

Recruiting

Address

Medvin Clinical Research

Covina, California, 91723

Omega Research Debary, LLC, DeBary, Florida

Status

Recruiting

Address

Omega Research Debary, LLC

DeBary, Florida, 32713

San Marcus Research Clinic, Inc., Miami, Florida

Status

Recruiting

Address

San Marcus Research Clinic, Inc.

Miami, Florida, 33015

Arthritis Center, Inc., Palm Harbor, Florida

Status

Active, not recruiting

Address

Arthritis Center, Inc.

Palm Harbor, Florida, 85234

Jefrey D. Lieberman, ND, P.C., Decatur, Georgia

Status

Recruiting

Address

Jefrey D. Lieberman, ND, P.C.

Decatur, Georgia, 30033

Bluegrass Community Research, Inc., Lexington, Kentucky

Status

Recruiting

Address

Bluegrass Community Research, Inc.

Lexington, Kentucky, 40504

Klein & Associates, M.D., P.A., Hagerstown, Maryland

Status

Recruiting

Address

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, 21740

Saint Clair Shores, Michigan

Status

Recruiting

Address

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, 48081

St. Paul Rheumatology, P.A., Eagan, Minnesota

Status

Recruiting

Address

St. Paul Rheumatology, P.A.

Eagan, Minnesota, 55121

Arthritis Consultants, Inc., Saint Louis, Missouri

Status

Recruiting

Address

Arthritis Consultants, Inc.

Saint Louis, Missouri, 63141

Atlantic Coast Research, Toms River, New Jersey

Status

Recruiting

Address

Atlantic Coast Research

Toms River, New Jersey, 08755

Joint and Muscle Research Institute, Charlotte, North Carolina

Status

Recruiting

Address

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204

Middleburg Heights, Ohio

Status

Recruiting

Address

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, 44130

Clinical Research Source Inc, Perrysburg, Ohio

Status

Recruiting

Address

Clinical Research Source Inc

Perrysburg, Ohio, 43551

Altoona Center for Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

Arthritis Group, PC, Philadelphia, Pennsylvania

Status

Recruiting

Address

Arthritis Group, PC

Philadelphia, Pennsylvania, 19152

Wyomissing, Pennsylvania

Status

Recruiting

Address

PA Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, 19610

Columbia, South Carolina

Status

Recruiting

Address

Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA

Columbia, South Carolina, 29204

ACME Research, LLC, Orangeburg, South Carolina

Status

Recruiting

Address

ACME Research, LLC

Orangeburg, South Carolina, 29118

College Station, Texas

Status

Recruiting

Address

Arthritis & Osteoporosis Clinic of Brazos Valley (Drug Shipment Address)

College Station, Texas, 77845

Southwest Rheumatology Research, LLC, Mesquite, Texas

Status

Recruiting

Address

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150

West Virginia Research Institute PLLC, South Charleston, West Virginia

Status

Recruiting

Address

West Virginia Research Institute PLLC

South Charleston, West Virginia, 25309

International Sites

Genesis Research Services, Broadmeadow, New South Wales, Australia

Status

Recruiting

Address

Genesis Research Services

Broadmeadow, New South Wales, 2292

Rheumatology Research Unit, Maroochydore, Queensland, Australia

Status

Recruiting

Address

Rheumatology Research Unit

Maroochydore, Queensland, 4558

Emeritus Research, Camberwell, Victoria, Australia

Status

Recruiting

Address

Emeritus Research

Camberwell, Victoria, 3124

Quebec, Canada

Status

Recruiting

Address

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

Quebec, , G1V3M7

CCR Czech a.s., Pardubice, Czechia

Status

Recruiting

Address

CCR Czech a.s.

Pardubice, , 530 02

Uherske Hradiste, Czechia

Status

Recruiting

Address

Reumatologie a Osteologie MEDICAL PLUS s.r.o., Rezidence Hradebni, Obchodni 1507, Uherske Hradiste, 68601

Uherske Hradiste, , 68601

Obudai Egeszsegugyi Centrum Kft., Budapest, Hungary

Status

Recruiting

Address

Obudai Egeszsegugyi Centrum Kft.

Budapest, , 1036

Gyula, Hungary

Status

Recruiting

Address

Bekes Megeyi Kozponti Korhaz, Reumatologiai Osztaly

Gyula, , 5700

Szentes, Hungary

Status

Recruiting

Address

Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly

Szentes, , 6600

Hachioji-shi, Japan

Status

Recruiting

Address

Tokyo Medical University Hachioji Medical Center

Hachioji-shi, , 193-0998

Kawachinagano, Japan

Status

Recruiting

Address

National Hospital Organization Osaka Minami Medical Center

Kawachinagano, , 586-8521

Nagoya City University Hospital, Nagoya-City, Japan

Status

Not yet recruiting

Address

Nagoya City University Hospital

Nagoya-City, , 467-8602

Daido Clinic, Nagoya, Japan

Status

Recruiting

Address

Daido Clinic

Nagoya, , 457-8511

Inha University Hospital, Incheon, Korea, Republic of

Status

Recruiting

Address

Inha University Hospital

Incheon, , 22332

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

SMG - SNU Boramae Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

SMG - SNU Boramae Medical Center

Seoul, , 07061

Bialystok, Podlaskie, Poland

Status

Recruiting

Address

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, Podlaskie, , 15-099

NSZOZ Unica CR, Dabrówka, Poland

Status

Recruiting

Address

NSZOZ Unica CR

Dabrówka, , 62096

Gdansk, Poland

Status

Recruiting

Address

Centrum Badan Klinicznych PI-House sp. z o.o

Gdansk, , 80-546

Katowice, Poland

Status

Recruiting

Address

Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, , 40-040

Rheuma Medicus Zaklad Opieki Zdrowotnej, Warsaw, Poland

Status

Recruiting

Address

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, , 02-118

ARS RHEUMATICA Sp. Z.o.o., Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

ARS RHEUMATICA Sp. Z.o.o.

Warszawa, Mazowieckie, , 02-691

Centrum Medyczne AMED Warszawa Targowek, Warszawa, Poland

Status

Recruiting

Address

Centrum Medyczne AMED Warszawa Targowek

Warszawa, , 03-921

Centrum Medyczne Oporow, Wroclaw, Poland

Status

Recruiting

Address

Centrum Medyczne Oporow

Wroclaw, , 52-416

Fuenlabrada, Spain

Status

Recruiting

Address

Hospital Universitario de Fuenlabrada - Rheumatology Department, Camino Del Molino no 2, Fuenlabrada, Madrid, 28942

Fuenlabrada, , 28942

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz. Paseo de la Castellana 261, Madrid, 28046

Madrid, , 28046

Sabadell, Spain

Status

Recruiting

Address

Corporacio Sanitaria Parc Tauli, Parc Tauli 1, Rheumatology Service, Sabadell, Barcelona, 08208

Sabadell, , 8208

Santander, Spain

Status

Recruiting

Address

Hospital Universitario Marques de Valdecilla, Rheumatology Service, Avda. Valdecilla s/n, 39008

Santander, , 39008

Hospital Universitario Virgen Macarena, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen Macarena

Sevilla, , 41007

Buddhist Dalin Tzu Chi Hospital, Dailin Township, Taiwan

Status

Recruiting

Address

Buddhist Dalin Tzu Chi Hospital

Dailin Township, , 622

Chi Mei Medical Center, Tainan, Taiwan

Status

Recruiting

Address

Chi Mei Medical Center

Tainan, , 71004

Taipei, Taiwan

Status

Recruiting

Address

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taipei, , 10507

Taipei Medical University Hospital, Taipei, Taiwan

Status

Recruiting

Address

Taipei Medical University Hospital

Taipei, , 11031

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