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

NCT04115839 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: GS-US-431-45672019-002021-29JapicCTI-205201
• Study Type: interventional
• Target: 106
• Locations: 11 countries
• Sites: 59

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12

  ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: patient's global assessment of disease activity (PGADA) using a visual analogue scale (VAS) on a scale of 0 (very well) to 100 (very poor); physician's global assessment of disease activity (PHGADA) using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); health assessment questionnaire-disability index (HAQ-DI) inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain), and high-sensitivity C-reactive protein (hsCRP).

  Week 12

Secondary Outcomes (76)

• Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16

  Baseline, 4, and 16 weeks

• Change From Baseline in PASDAS at Week 48

  Baseline, Week 48

• Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16

  Weeks 4, 8, 12, and 16

• Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48

  Weeks 20, 24, 28, 36, and 48

• Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16

  Weeks 4, 8, 12, and 16

Study Arms (5)

Filgotinib 200 mg (Main Study)

EXPERIMENTAL

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

Drug: Filgotinib; Drug: Placebo to match filgotinib

Filgotinib 100 mg (Main Study)

EXPERIMENTAL

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

Drug: Filgotinib; Drug: Placebo to match filgotinib

Placebo (Main Study)

PLACEBO COMPARATOR

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

Drug: Placebo to match filgotinib

Filgotinib 200 mg (LTE)

EXPERIMENTAL

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

Drug: Filgotinib; Drug: Placebo to match filgotinib

Filgotinib 100 mg (LTE)

EXPERIMENTAL

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

Drug: Filgotinib; Drug: Placebo to match filgotinib

Interventions

Filgotinib DRUG

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

Also known as: GS-6034, GLPG0634

Filgotinib 100 mg (LTE); Filgotinib 100 mg (Main Study); Filgotinib 200 mg (LTE); Filgotinib 200 mg (Main Study)

Placebo to match filgotinib DRUG

Tablets administered orally once daily with or without food.

Filgotinib 100 mg (LTE); Filgotinib 100 mg (Main Study); Filgotinib 200 mg (LTE); Filgotinib 200 mg (Main Study); Placebo (Main Study)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead
• Galapagos NV: collaborator

Study Sites (59)

Medvin Clinical Research

Covina, California, 91723, United States

Location

Omega Research Debary, LLC

DeBary, Florida, 32713, United States

Location

San Marcus Research Clinic, Inc.

Miami, Florida, 33015, United States

Location

Arthritis Center, Inc.

Palm Harbor, Florida, 85234, United States

Location

Jefrey D. Lieberman, ND, P.C.

Decatur, Georgia, 30033, United States

Location

Bluegrass Community Research, Inc.

Lexington, Kentucky, 40504, United States

Location

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

Hagerstown, Maryland, 21740, United States

Location

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, 48081, United States

Location

St. Paul Rheumatology, P.A.

Eagan, Minnesota, 55121, United States

Location

Arthritis Consultants, Inc.

St Louis, Missouri, 63141, United States

Location

Atlantic Coast Research

Toms River, New Jersey, 08755, United States

Location

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204, United States

Location

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Clinical Research Source Inc

Perrysburg, Ohio, 43551, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Arthritis Group, PC

Philadelphia, Pennsylvania, 19152, United States

Location

PA Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, 19610, United States

Location

Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA

Columbia, South Carolina, 29204, United States

Location

ACME Research, LLC

Orangeburg, South Carolina, 29118, United States

Location

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

College Station, Texas, 77845, United States

Location

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150, United States

Location

West Virginia Research Institute PLLC

South Charleston, West Virginia, 25309, United States

Location

Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia

Location

Rheumatology Research Unit

Maroochydore, Queensland, 4558, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

CHU UCL Namur - Site Godinne

Yvoir, 5530, Belgium

Location

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

Québec, G1V3M7, Canada

Location

CCR Czech a.s.

Pardubice, 530 02, Czechia

Location

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

Uherské Hradiště, 68601, Czechia

Location

Obudai Egeszsegugyi Centrum Kft.

Budapest, 1036, Hungary

Location

Bekes Megeyi Kozponti Korhaz, Reumatologiai Osztaly

Gyula, 5700, Hungary

Location

Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly

Szentes, 6600, Hungary

Location

Tokyo Medical University Hachioji Medical Center

Hachioji-shi, 193-0998, Japan

Location

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, 586-8521, Japan

Location

Daido Clinic

Nagoya, 457-8511, Japan

Location

Nagoya City University Hospital

Nagoya, 467-8602, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, Podlaskie, 15-099, Poland

Location

NSZOZ Unica CR

Dabrówka, 62096, Poland

Location

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

Gdansk, 80-546, Poland

Location

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

Katowice, 40-040, Poland

Location

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, 02-118, Poland

Location

Centrum Medyczne AMED Warszawa Targowek

Warsaw, 03-921, Poland

Location

ARS RHEUMATICA Sp. Z.o.o.

Warszawa, Mazowieckie, 02-691, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

SMG - SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

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

Fuenlabrada, 28942, Spain

Location

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

Madrid, 28041, Spain

Location

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

Madrid, 28046, Spain

Location

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

Sabadell, 8208, Spain

Location

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

Santander, 39008, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41007, Spain

Location

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

Valencia, 46010, Spain

Location

Buddhist Dalin Tzu Chi Hospital

Dailin Township, 622, Taiwan

Location

Chi Mei Medical Center

Tainan, 71004, Taiwan

Location

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taipei, 10507, Taiwan

Location

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: November 13, 2019
• Primary Completion: January 4, 2021
• Study Completion: March 18, 2021
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2); ES (7); BE (1); HU (3); PL (8); US (22); AU (3); JP (5); TW (4); CA (1); KR (3)