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Clinical Trials/NCT04115839
NCT04115839
Terminated
Phase 3

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy

Gilead Sciences59 sites in 10 countries106 target enrollmentNovember 13, 2019
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ConditionsPsoriatic Arthritis
InterventionsFilgotinibPlacebo to match filgotinib
DrugsFilgotinibPlacebo to match filgotinib

Overview

Phase
Phase 3
Intervention
Filgotinib
Conditions
Psoriatic Arthritis
Sponsor
Gilead Sciences
Enrollment
106
Locations
59
Primary Endpoint
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12
Status
Terminated
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 13, 2019
End Date
March 18, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • •Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Arms & Interventions

Filgotinib 200 mg (Main Study)

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

Intervention: Filgotinib

Filgotinib 200 mg (Main Study)

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

Intervention: Placebo to match filgotinib

Filgotinib 100 mg (Main Study)

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

Intervention: Filgotinib

Filgotinib 100 mg (Main Study)

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

Intervention: Placebo to match filgotinib

Placebo (Main Study)

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

Intervention: Placebo to match filgotinib

Filgotinib 200 mg (LTE)

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

Intervention: Filgotinib

Filgotinib 200 mg (LTE)

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

Intervention: Placebo to match filgotinib

Filgotinib 100 mg (LTE)

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

Intervention: Filgotinib

Filgotinib 100 mg (LTE)

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

Intervention: Placebo to match filgotinib

Outcomes

Primary Outcomes

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

Time Frame: 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).

Secondary Outcomes

  • Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline(Baseline, 20, 24, 28, 36, and 48 weeks)
  • Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16(Baseline, 2, 4, 8, 12, and 16 weeks)
  • Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60(Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16(Baseline, 4, and 16 weeks)
  • Change From Baseline in FACIT-Fatigue Scale Score at Week 48(Baseline, Week 48)
  • Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16(Baseline, 4, and 16 weeks)
  • Change From Baseline in MCS of the SF-36v2 at Week 48(Baseline, Week 48)
  • Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16(Baseline, 4, and 16 weeks)
  • Change From Baseline in PCS of the SF-36v2 at Week 48(Baseline, Week 48)
  • 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)
  • Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48(Weeks 20, 24, 28, 36, and 48)
  • 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 DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60(Baseline, 18, 20, 24, 28, 36, 48, and 60 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)
  • Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline(Baseline, 18, 20, 24, 28, 36, and 48 weeks)
  • 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(Baseline, 4, 8, 12, and 16 weeks)
  • Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline(Baseline, 20, 24, 28, 36, and 48 weeks)
  • Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline(Baseline, 4, 8, 12, and 16 weeks)
  • Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline(Baseline, 20, 24, 28, 36, and 48 weeks)
  • Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16(Baseline, 4, and 16 weeks)
  • Change From Baseline in PsAID-12 Score at Week 48(Baseline, Week 48)
  • Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16(Weeks 4 and 16)
  • Percentage of Participants With PASDAS LDA at Week 48(Week 48)
  • Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60(Weeks 18, 20, 24, 28, 36, 48, and 60)
  • Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16(Baseline, 2, 4, 8, 12, and 16 weeks)
  • Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60(Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks)
  • Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16(Weeks 4 and 16)
  • Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
  • Percentage of Participants Who Achieved PASDAS Remission at Week 48(Week 48)
  • Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60(Weeks 18, 20, 24, 28, 36, 48, and 60)
  • Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16(Baseline, 2, 4, 8, 12, and 16 weeks)
  • Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60(Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks)
  • Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16(Baseline, 2, 4, 8, 12, and 16 weeks)
  • Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60(Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks)
  • 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(Baseline, 2, 4, 8, 12, and 16 weeks)
  • Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60(Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks)
  • Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16(Baseline, 2, 4, 8, 12, and 16 weeks)
  • Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
  • Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60(Weeks 18, 20, 24, 28, 36, 48, and 60)
  • Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16(Baseline, 2, 4, 8, 12, and 16 weeks)
  • Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60(Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks)
  • Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60(Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks)
  • Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16(Baseline, 2, 4, 8, 12, and 16 weeks)
  • Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60(Baseline, 18, 20, 24, 28, 36, 48 and 60 weeks)
  • Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
  • Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60(Weeks 18, 20, 24, 28, 36, 48, and 60)
  • Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
  • Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60(Weeks 18, 20, 24, 28, 36, 48, and 60)
  • Time to Achieve DAS28(CRP) LDA(Approximately 16 weeks)
  • Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
  • Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60(Weeks 18, 20, 24, 28, 36, 48, and 60)
  • Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
  • Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60(Weeks 18, 20, 24, 28, 36, 48, and 60)
  • Time to Achieve DAPSA LDA(Approximately 16 weeks)
  • Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16(Weeks 2, 4, 8, 12, and 16)
  • Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60(Weeks 18, 20, 24, 28, 36, 48, and 60)
  • 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(Baseline, 4, 8, 12, and 16 weeks)
  • Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline(Baseline, 20, 24, 28, 36, and 48 weeks)
  • 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(Weeks 4, 8, 12, and 16)
  • Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline(Weeks 20, 24, 28, 36, and 48)
  • 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(Weeks 4, 8, 12, and 16)
  • Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline(Weeks 20, 24, 28, 36, and 48)
  • 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(Weeks 4, 8, 12, and 16)
  • Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline(Baseline, 20, 24, 28, 36, and 48 weeks)
  • Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline(Weeks 20, 24, 28, 36, and 48)
  • 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(Weeks 4, 8, 12, and 16)
  • Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline(Baseline, 4, 8, 12, and 16 weeks)
  • Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline(Weeks 20, 24, 28, 36, and 48)
  • 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(Baseline, 4, 8, 12, and 16 weeks)
  • Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline(Baseline, 4, 8, 12, and 16 weeks)
  • Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline(Baseline, 20, 24, 28, 36, and 48 weeks)

Study Sites (59)

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