Clinical trial NCT04115748: Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
Official title: A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2019-10-04
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Key Inclusion Criteria:

* 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

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.

Primary outcomes:
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
measure: Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
timeFrame: Weeks 4, 8, 12, and 16
measure: Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: 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
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
measure: Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16
timeFrame: Weeks 4, and 16
measure: Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16
timeFrame: Weeks 4, and 16
measure: Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved DAS28 (CRP) Remission at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Time to Achieve DAS28 (CRP) LDA
timeFrame: Up to 19 weeks
measure: Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Time to Achieve DAPSA LDA
timeFrame: Up to 19 weeks
measure: Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 4, 8, 12, and 16
measure: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
measure: Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
measure: Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
Other outcomes:
Locations:
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: DeBary
country: United States
facility: Omega Research Debary, LLC
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Orlando
country: United States
facility: Hmd Research Llc
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc.
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group, Inc.
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group
state: Georgia
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Saint Clair Shores
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology, P.A.
state: Minnesota
city: Saint Louis
country: United States
facility: Arthritis Consultants, Inc.
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaaboration, LLCs
state: Nebraska
city: Toms River
country: United States
facility: Atlantic Coast Research
state: New Jersey
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source Inc
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Columbia
country: United States
facility: Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA
state: South Carolina
city: Orangeburg
country: United States
facility: ACME Research, LLC
state: South Carolina
city: College Station
country: United States
facility: Arthritis & Osteoporosis Clinic of Brazos Valley (Drug Shipment Address)
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC
state: Texas
city: South Charleston
country: United States
facility: West Virginia Research Institute PLLC
state: West Virginia
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment - Plovdiv AD, Department Of Rheumatology
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Lyulin" EAD, Department of Rheumatology
city: Sofia
country: Bulgaria
facility: Diagnostic consultative center 17 Sofia EOOD
city: Sofia
country: Bulgaria
facility: "Medical center Synexus Sofia" EOOD
city: Stara Zagora
country: Bulgaria
facility: "Medical center SYNEXUS SOFIA" EOOD, branch Stara Zagora
city: Quebec
country: Canada
facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
city: Ostrava
country: Czechia
facility: CCR Ostrava, s.r.o.
city: Budapest
country: Hungary
facility: Synexus (DRS) - Synexus Magyarorszag Kft. Budapest
city: Gyula
country: Hungary
facility: Synexus (DRS) - Synexus Magyarorszag Kft. Gyula
city: Kawachinagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
city: Nagoya-City
country: Japan
facility: Nagoya City University Hospital
city: Nagoya
country: Japan
facility: Daido Clinic
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
city: Hamilton
country: New Zealand
facility: Waikato Hospital
state: WKO
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Newtown
country: New Zealand
facility: Capital & Coast District Health Board
city: Timaru
country: New Zealand
facility: Clinical Trials Unit, Timaru Hospital
city: Bialystok, Podlaskie
country: Poland
facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela
city: Dabrówka
country: Poland
facility: NSZOZ Unica CR
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
city: Krakow
country: Poland
facility: Malopolskie Badania Kliniczne SP Z O O Sp. k.
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED s.c.
city: Olsztyn
country: Poland
facility: ETYKA Osrodek Badan Klinicznych
city: Warsaw
country: Poland
facility: Pheuma Medicus Zaklad Opieki Zdrowotnej
city: Warszawa, Mazowieckie
country: Poland
facility: ARS RHEUMATICA Sp. Z.o.o., "REUMATIKA-Centrum Reumatologii", NZOZ
city: Warszawa
country: Poland
facility: Medycyna Kliniczna Marzena Waszczak-Jeka
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Warszawa
city: Warszawa
country: Poland
facility: REUMATOLOG WARSZAWA Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Moskva
country: Russian Federation
facility: Ulitsa Delegatskaya, 20, Building 1, Ulitsa Kasatkina, 7 Moscow, Russia, 127473/129301
city: Vladimir
country: Russian Federation
facility: LLC "Biomed"
city: Yaroslavl
country: Russian Federation
facility: Center for medical advice and research - PRACTICE LTD
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre, Avenida de Cordoba s/n, Rheumatology Service, Madrid, Spain, 28041
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla, Rheumatology Service, Avda. Valdecilla s/n, Santander, Cantabria, 39008
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Dailin Township
country: Taiwan
facility: Buddhist Dalin Tzu Chi Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Keelung
country: Taiwan
facility: Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: