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

NCT ID: NCT04115839

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-13
• Study Completion Date: 2021-03-18

Brief 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.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Filgotinib 200 mg (Main Study)

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

Group Type: EXPERIMENTAL

Filgotinib

Intervention Type: DRUG

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

Placebo to match filgotinib

Intervention Type: DRUG

Tablets administered orally once daily with or without food.

Filgotinib 100 mg (Main Study)

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

Group Type: EXPERIMENTAL

Filgotinib

Intervention Type: DRUG

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

Placebo to match filgotinib

Intervention Type: DRUG

Tablets administered orally once daily with or without food.

Placebo (Main Study)

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

Group Type: PLACEBO_COMPARATOR

Placebo to match filgotinib

Intervention Type: DRUG

Tablets administered orally once daily with or without food.

Filgotinib 200 mg (LTE)

Participants will receive filgotinib 200 mg + PTM filgotinib 100 mg for up to 44 weeks.

Group Type: EXPERIMENTAL

Filgotinib

Intervention Type: DRUG

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

Placebo to match filgotinib

Intervention Type: DRUG

Tablets administered orally once daily with or without food.

Filgotinib 100 mg (LTE)

Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 44 weeks.

Group Type: EXPERIMENTAL

Filgotinib

Intervention Type: DRUG

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

Placebo to match filgotinib

Intervention Type: DRUG

Tablets administered orally once daily with or without food.

Interventions

Filgotinib

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

Intervention Type: DRUG

Placebo to match filgotinib

Tablets administered orally once daily with or without food.

Intervention Type: DRUG

Other Intervention Names

GS-6034; GLPG0634

Eligibility 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 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Medvin Clinical Research

Covina, California, United States

Omega Research Debary, LLC

DeBary, Florida, United States

San Marcus Research Clinic, Inc.

Miami, Florida, United States

Arthritis Center, Inc.

Palm Harbor, Florida, United States

Jefrey D. Lieberman, ND, P.C.

Decatur, Georgia, United States

Bluegrass Community Research, Inc.

Lexington, Kentucky, United States

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

Hagerstown, Maryland, United States

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, United States

St. Paul Rheumatology, P.A.

Eagan, Minnesota, United States

Arthritis Consultants, Inc.

St Louis, Missouri, United States

Atlantic Coast Research

Toms River, New Jersey, United States

Joint and Muscle Research Institute

Charlotte, North Carolina, United States

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States

Clinical Research Source Inc

Perrysburg, Ohio, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Arthritis Group, PC

Philadelphia, Pennsylvania, United States

PA Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, United States

Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA

Columbia, South Carolina, United States

ACME Research, LLC

Orangeburg, South Carolina, United States

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

College Station, Texas, United States

Southwest Rheumatology Research, LLC

Mesquite, Texas, United States

West Virginia Research Institute PLLC

South Charleston, West Virginia, United States

Genesis Research Services

Broadmeadow, New South Wales, Australia

Rheumatology Research Unit

Maroochydore, Queensland, Australia

Emeritus Research

Camberwell, Victoria, Australia

CHU UCL Namur - Site Godinne

Yvoir, , Belgium

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

Québec, , Canada

CCR Czech a.s.

Pardubice, , Czechia

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

Uherské Hradiště, , Czechia

Obudai Egeszsegugyi Centrum Kft.

Budapest, , Hungary

Bekes Megeyi Kozponti Korhaz, Reumatologiai Osztaly

Gyula, , Hungary

Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly

Szentes, , Hungary

Tokyo Medical University Hachioji Medical Center

Hachioji-shi, , Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, , Japan

Daido Clinic

Nagoya, , Japan

Nagoya City University Hospital

Nagoya, , Japan

Keio University Hospital

Tokyo, , Japan

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, Podlaskie, , Poland

NSZOZ Unica CR

Dabrówka, , Poland

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

Gdansk, , Poland

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

Katowice, , Poland

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, , Poland

Centrum Medyczne AMED Warszawa Targowek

Warsaw, , Poland

ARS RHEUMATICA Sp. Z.o.o.

Warszawa, Mazowieckie, , Poland

Centrum Medyczne Oporow

Wroclaw, , Poland

Inha University Hospital

Incheon, , South Korea

Seoul National University Hospital

Seoul, , South Korea

SMG - SNU Boramae Medical Center

Seoul, , South Korea

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

Fuenlabrada, , Spain

Hospital Universitario 12 de Octubre, Avenida de Cordoba, s/n, Madrid, Spain, 28041

Madrid, , Spain

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

Madrid, , Spain

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

Sabadell, , Spain

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

Santander, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Clinico Universitario de Valencia, Avenida Blasco Ibáñez, 17 Rheumatology Service, Valencia, Spain,

Valencia, , Spain

Buddhist Dalin Tzu Chi Hospital

Dailin Township, , Taiwan

Chi Mei Medical Center

Tainan City, , Taiwan

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taipei, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Countries

United States; Australia; Belgium; Canada; Czechia; Hungary; Japan; Poland; South Korea; Spain; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-002021-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

JapicCTI-205201

Identifier Type: REGISTRY

Identifier Source: secondary_id

GS-US-431-4567

Identifier Type: -

Identifier Source: org_study_id