Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive 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 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).

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

Key

Inclusion Criteria:

  • - Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and 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 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.

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.

NCT04115748
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, Bulgaria, Canada, Hungary, Japan, Korea, Republic of, New Zealand, Poland, Russian Federation, 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 + PTM adalimumab injection for up to 16 weeks.

Experimental: Filgotinib 100 mg (Main Study)

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

Active Comparator: Adalimumab (Main Study)

Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg + adalimumab 40 mg injection for up to 16 weeks.

Placebo Comparator: Placebo (Main Study)

Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg + PTM adalimumab injection 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 administered orally once daily with or without food

Drug: - Adalimumab

Injection administered subcutaneously once every 2 weeks

Drug: - Placebo to match filgotinib

Tablets administered orally once daily with or without food

Drug: - Placebo to match adalimumab

Injection administered subcutaneously once every 2 weeks

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

Active, not recruiting

Address

Medvin Clinical Research

Covina, California, 91723

Omega Research Debary, LLC, DeBary, Florida

Status

Active, not recruiting

Address

Omega Research Debary, LLC

DeBary, Florida, 32713

San Marcus Research Clinic, Inc., Miami, Florida

Status

Active, not recruiting

Address

San Marcus Research Clinic, Inc.

Miami, Florida, 33015

Hmd Research Llc, Orlando, Florida

Status

Recruiting

Address

Hmd Research Llc

Orlando, Florida, 32819

Arthritis Center, Inc., Palm Harbor, Florida

Status

Active, not recruiting

Address

Arthritis Center, Inc.

Palm Harbor, Florida, 85234

ForCare Clinical Research, Tampa, Florida

Status

Not yet recruiting

Address

ForCare Clinical Research

Tampa, Florida, 33613

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

Status

Active, not recruiting

Address

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

Hagerstown, Maryland, 21740

Saint Clair Shores, Michigan

Status

Active, not recruiting

Address

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, 48081

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

Status

Active, not recruiting

Address

St. Paul Rheumatology, P.A.

Eagan, Minnesota, 55121

Arthritis Consultants, Inc., Saint Louis, Missouri

Status

Active, not recruiting

Address

Arthritis Consultants, Inc.

Saint Louis, Missouri, 63141

Physician Research Collaaboration, LLCs, Lincoln, Nebraska

Status

Active, not recruiting

Address

Physician Research Collaaboration, LLCs

Lincoln, Nebraska, 68516

Atlantic Coast Research, Toms River, New Jersey

Status

Active, not recruiting

Address

Atlantic Coast Research

Toms River, New Jersey, 08755

Joint and Muscle Research Institute, Charlotte, North Carolina

Status

Active, not recruiting

Address

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204

Middleburg Heights, Ohio

Status

Active, not 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

Active, not recruiting

Address

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

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

Active, not recruiting

Address

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150

West Virginia Research Institute PLLC, South Charleston, West Virginia

Status

Active, not 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

Sofia, Bulgaria

Status

Recruiting

Address

Diagnostic consultative center 17 Sofia EOOD

Sofia, , 1505

"Medical center Synexus Sofia" EOOD, Sofia, Bulgaria

Status

Recruiting

Address

"Medical center Synexus Sofia" EOOD

Sofia, , 1784

Stara Zagora, Bulgaria

Status

Recruiting

Address

"Medical center SYNEXUS SOFIA" EOOD, branch Stara Zagora

Stara Zagora, , 6000

Quebec, Canada

Status

Recruiting

Address

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

Quebec, , G1V3M7

Budapest, Hungary

Status

Recruiting

Address

Synexus (DRS) - Synexus Magyarorszag Kft. Budapest

Budapest, , 1036

Kawachinagano, Japan

Status

Recruiting

Address

National Hospital Organization Osaka Minami Medical Center

Kawachinagano, , 586-8521

Nagoya City University Hospital, Nagoya-City, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya-City, , 467-8602

Daido Clinic, Nagoya, Japan

Status

Active, not recruiting

Address

Daido Clinic

Nagoya, , 457-8511

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

Waikato Hospital, Hamilton, WKO, New Zealand

Status

Recruiting

Address

Waikato Hospital

Hamilton, WKO, 3240

Optimal Clinical Trials, Auckland, New Zealand

Status

Recruiting

Address

Optimal Clinical Trials

Auckland, , 1010

Capital & Coast District Health Board, Newtown, New Zealand

Status

Recruiting

Address

Capital & Coast District Health Board

Newtown, , 6021

Clinical Trials Unit, Timaru Hospital, Timaru, New Zealand

Status

Recruiting

Address

Clinical Trials Unit, Timaru Hospital

Timaru, , 7910

Bialystok, Podlaskie, Poland

Status

Recruiting

Address

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, Podlaskie, , 15-099

Bydgoszcz, Poland

Status

Recruiting

Address

Szpital Uniwersytecki nr 2 im. dr Jana Biziela

Bydgoszcz, , 85-168

NSZOZ Unica CR, Dabrówka, Poland

Status

Recruiting

Address

NSZOZ Unica CR

Dabrówka, , 62096

Krakow, Poland

Status

Recruiting

Address

Malopolskie Badania Kliniczne SP Z O O Sp. k.

Krakow, , 30-349

NZOZ Lecznica MAK-MED s.c., Nadarzyn, Poland

Status

Recruiting

Address

NZOZ Lecznica MAK-MED s.c.

Nadarzyn, , 05-830

ETYKA Osrodek Badan Klinicznych, Olsztyn, Poland

Status

Recruiting

Address

ETYKA Osrodek Badan Klinicznych

Olsztyn, , 10-117

Pheuma Medicus Zaklad Opieki Zdrowotnej, Warsaw, Poland

Status

Recruiting

Address

Pheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, , 02-118

Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

ARS RHEUMATICA Sp. Z.o.o., "REUMATIKA-Centrum Reumatologii", NZOZ

Warszawa, Mazowieckie, , 02-691

Medycyna Kliniczna Marzena Waszczak-Jeka, Warszawa, Poland

Status

Recruiting

Address

Medycyna Kliniczna Marzena Waszczak-Jeka

Warszawa, , 00-874

Centrum Medyczne AMED Warszawa, Warszawa, Poland

Status

Recruiting

Address

Centrum Medyczne AMED Warszawa

Warszawa, , 03-921

Warszawa, Poland

Status

Recruiting

Address

REUMATOLOG WARSZAWA Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler

Warszawa, , 04-305

Centrum Medyczne Oporow, Wroclaw, Poland

Status

Recruiting

Address

Centrum Medyczne Oporow

Wroclaw, , 52-416

Moskva, Russian Federation

Status

Recruiting

Address

Ulitsa Delegatskaya, 20, Building 1, Ulitsa Kasatkina, 7 Moscow, Russia, 127473/129301

Moskva, , 127473

Santander, Spain

Status

Recruiting

Address

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

Not yet recruiting

Address

Buddhist Dalin Tzu Chi Hospital

Dailin Township, , 622

Kaohsiung, Taiwan

Status

Recruiting

Address

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, , 833

Keelung, Taiwan

Status

Recruiting

Address

Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital

Keelung, , 204

Far Eastern Memorial Hospital, New Taipei City, Taiwan

Status

Recruiting

Address

Far Eastern Memorial Hospital

New Taipei City, , 220

National Cheng Kung University Hospital, Tainan, Taiwan

Status

Recruiting

Address

National Cheng Kung University Hospital

Tainan, , 70403

Taipei Medical University Hospital, Taipei, Taiwan

Status

Recruiting

Address

Taipei Medical University Hospital

Taipei, , 11031

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