Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

NCT04115748 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: GS-US-431-45662019-001996-35JapicCTI-205202
• Study Type: interventional
• Target: 67
• Locations: 13 countries
• Sites: 74

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 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).

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 (39)

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

  Baseline, 4, and 16 weeks

• 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 Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16

  Weeks 4, 8, 12, and 16

• Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16

  Baseline, 2, 4, 8, 12, and 16 weeks

• Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline

  Baseline, 2, 4, 8, 12, and 16 weeks

Study Arms (6)

Filgotinib 200 mg (Main Study)

EXPERIMENTAL

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

Drug: Filgotinib; Drug: Placebo to match filgotinib; Drug: Placebo to match adalimumab

Filgotinib 100 mg (Main Study)

EXPERIMENTAL

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

Drug: Filgotinib; Drug: Placebo to match filgotinib; Drug: Placebo to match adalimumab

Adalimumab (Main Study)

ACTIVE COMPARATOR

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

Drug: Adalimumab; Drug: Placebo to match filgotinib

Placebo (Main Study)

PLACEBO COMPARATOR

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

Drug: Placebo to match filgotinib; Drug: Placebo to match adalimumab

Filgotinib 200 mg (Long Term Extension [LTE])

EXPERIMENTAL

Participants will receive filgotinib 200 mg + PTM filgotinib 100 mg for up to 34 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 34 weeks.

Drug: Filgotinib; Drug: Placebo to match filgotinib

Interventions

Filgotinib DRUG

Tablets 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 (Long Term Extension [LTE]); Filgotinib 200 mg (Main Study)

Adalimumab DRUG

Injection administered subcutaneously once every 2 weeks

Adalimumab (Main Study)

Placebo to match filgotinib DRUG

Tablets administered orally once daily with or without food

Adalimumab (Main Study); Filgotinib 100 mg (LTE); Filgotinib 100 mg (Main Study); Filgotinib 200 mg (Long Term Extension [LTE]); Filgotinib 200 mg (Main Study); Placebo (Main Study)

Placebo to match adalimumab DRUG

Injection administered subcutaneously once every 2 weeks

Filgotinib 100 mg (Main Study); 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead
• Galapagos NV: collaborator

Study Sites (74)

Medvin Clinical Research

Covina, California, 91723, United States

Location

Bay Area Arthritis and Osteoporosis

Brandon, Florida, 33511, United States

Location

Omega Research Debary, LLC

DeBary, Florida, 32713, United States

Location

San Marcus Research Clinic, Inc.

Miami, Florida, 33015, United States

Location

Hmd Research Llc

Orlando, Florida, 32819, United States

Location

Arthritis Center, Inc.

Palm Harbor, Florida, 85234, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

BayCare Medical Group, Inc.

Tampa, Florida, 33614, United States

Location

North Georgia Rheumatology Group

Lawrenceville, Georgia, 30046, 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

Physician Research Collaaboration, LLCs

Lincoln, Nebraska, 68516, 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

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

University Multiprofile Hospital for Active Treatment - Plovdiv AD, Department Of Rheumatology

Plovdiv, 4003, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Lyulin" EAD, Department of Rheumatology

Sofia, 1336, Bulgaria

Location

Diagnostic consultative center 17 Sofia EOOD

Sofia, 1505, Bulgaria

Location

"Medical center Synexus Sofia" EOOD

Sofia, 1784, Bulgaria

Location

"Medical center SYNEXUS SOFIA" EOOD, branch Stara Zagora

Stara Zagora, 6000, Bulgaria

Location

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

Québec, G1V3M7, Canada

Location

CCR Ostrava, s.r.o.

Ostrava, 702 00, Czechia

Location

Synexus (DRS) - Synexus Magyarorszag Kft. Budapest

Budapest, 1036, Hungary

Location

Synexus (DRS) - Synexus Magyarorszag Kft. Gyula

Gyula, 5700, Hungary

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

Waikato Hospital

Hamilton, WKO, 3240, New Zealand

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

Capital & Coast District Health Board

Newtown, 6021, New Zealand

Location

Clinical Trials Unit, Timaru Hospital

Timaru, 7910, New Zealand

Location

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, Podlaskie, 15-099, Poland

Location

Szpital Uniwersytecki nr 2 im. dr Jana Biziela

Bydgoszcz, 85-168, Poland

Location

NSZOZ Unica CR

Dabrówka, 62096, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

Location

Malopolskie Badania Kliniczne SP Z O O Sp. k.

Krakow, 30-349, Poland

Location

NZOZ Lecznica MAK-MED s.c.

Nadarzyn, 05-830, Poland

Location

ETYKA Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

Location

Medycyna Kliniczna Marzena Waszczak-Jeka

Warsaw, 00-874, Poland

Location

Pheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, 02-118, Poland

Location

Centrum Medyczne AMED Warszawa

Warsaw, 03-921, Poland

Location

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

Warsaw, 04-305, Poland

Location

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

Warszawa, Mazowieckie, 02-691, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

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

Moskva, 127473, Russia

Location

LLC "Biomed"

Vladimir, 600005, Russia

Location

Center for medical advice and research - PRACTICE LTD

Yaroslavl, 150003, Russia

Location

CHA Bundang Medical Center, CHA University

Seongnam, 13496, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

SMG - SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

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

Madrid, 28041, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, 8208, Spain

Location

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

Santander, 39008, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41007, Spain

Location

Buddhist Dalin Tzu Chi Hospital

Dailin Township, 622, Taiwan

Location

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

Chi Mei Medical Center

Tainan, 71004, Taiwan

Location

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

GLPG0634; Adalimumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to early termination of the study and insufficient number of participants enrolled, all the hypothesis testing performed and the p values reported were nominal. Therefore, the results need to be interpreted with caution.

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: December 3, 2019
• Primary Completion: January 19, 2021
• Study Completion: May 11, 2021
• Last Updated: May 16, 2022
• Results First Posted: May 16, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (24); CZ (1); TW (7); KR (3); CA (1); BU (5); HU (2); AU (3); NZ (4); JP (4); PL (13); ES (4); RU (3)