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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04115839

Registration number

NCT04115839

Ethics application status

Date submitted

2/10/2019

Date registered

4/10/2019

Date last updated

18/03/2022

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

2019-002021-29

Secondary ID [2]

GS-US-431-4567

Universal Trial Number (UTN)

Trial acronym

PENGUIN 2

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Psoriatic Arthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Inflammatory and Immune System

Rheumatoid arthritis

Inflammatory and Immune System

Other inflammatory or immune system disorders

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib

Experimental: Filgotinib 200 mg (Main Study) - Participants will receive filgotinib 200 mg + placebo to match (PTM) filgotinib 100 mg for up to 16 weeks.

Experimental: Filgotinib 100 mg (Main Study) - Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 16 weeks.

Placebo Comparator: Placebo (Main Study) - Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg for up to 16 weeks.

Experimental: Filgotinib 200 mg (LTE) - Participants will receive filgotinib 200 mg + PTM filgotinib 100 mg for up to 44 weeks.

Experimental: Filgotinib 100 mg (LTE) - Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 44 weeks.

Treatment: Drugs: Filgotinib
Tablets will be administered orally once daily with or without food.

Treatment: Drugs: Placebo to match filgotinib
Tablets administered orally once daily with or without food.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

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

Timepoint [1]

Week 12

Secondary outcome [1]

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

Timepoint [1]

Baseline, 4, and 16 weeks

Secondary outcome [2]

Change From Baseline in PASDAS at Week 48

Timepoint [2]

Baseline, Week 48

Secondary outcome [3]

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

Timepoint [3]

Weeks 4, 8, 12, and 16

Secondary outcome [4]

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

Timepoint [4]

Weeks 20, 24, 28, 36, and 48

Secondary outcome [5]

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

Timepoint [5]

Weeks 4, 8, 12, and 16

Secondary outcome [6]

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

Timepoint [6]

Weeks 20, 24, 28, 36, and 48

Secondary outcome [7]

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

Timepoint [7]

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

Secondary outcome [8]

Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [8]

Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks

Secondary outcome [9]

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

Timepoint [9]

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

Secondary outcome [10]

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

Timepoint [10]

Baseline, 18, 20, 24, 28, 36, and 48 weeks

Secondary outcome [11]

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

Timepoint [11]

Baseline, 4, 8, 12, and 16 weeks

Secondary outcome [12]

Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline

Timepoint [12]

Baseline, 20, 24, 28, 36, and 48 weeks

Secondary outcome [13]

Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline

Timepoint [13]

Baseline, 4, 8, 12, and 16 weeks

Secondary outcome [14]

Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline

Timepoint [14]

Baseline, 20, 24, 28, 36, and 48 weeks

Secondary outcome [15]

Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16

Timepoint [15]

Baseline, 4, and 16 weeks

Secondary outcome [16]

Change From Baseline in PsAID-12 Score at Week 48

Timepoint [16]

Baseline, Week 48

Secondary outcome [17]

Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16

Timepoint [17]

Weeks 4 and 16

Secondary outcome [18]

Percentage of Participants With PASDAS LDA at Week 48

Timepoint [18]

Week 48

Secondary outcome [19]

Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16

Timepoint [19]

Weeks 4 and 16

Secondary outcome [20]

Percentage of Participants Who Achieved PASDAS Remission at Week 48

Timepoint [20]

Week 48

Secondary outcome [21]

Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16

Timepoint [21]

Weeks 2, 4, 8, 12, and 16

Secondary outcome [22]

Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [22]

Weeks 18, 20, 24, 28, 36, 48, and 60

Secondary outcome [23]

Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16

Timepoint [23]

Weeks 2, 4, 8, 12, and 16

Secondary outcome [24]

Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [24]

Weeks 18, 20, 24, 28, 36, 48, and 60

Secondary outcome [25]

Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16

Timepoint [25]

Weeks 2, 4, 8, 12, and 16

Secondary outcome [26]

Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [26]

Weeks 18, 20, 24, 28, 36, 48, and 60

Secondary outcome [27]

Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16

Timepoint [27]

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

Secondary outcome [28]

Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [28]

Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks

Secondary outcome [29]

Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16

Timepoint [29]

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

Secondary outcome [30]

Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [30]

Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks

Secondary outcome [31]

Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16

Timepoint [31]

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

Secondary outcome [32]

Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [32]

Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks

Secondary outcome [33]

Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16

Timepoint [33]

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

Secondary outcome [34]

Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [34]

Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks

Secondary outcome [35]

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

Timepoint [35]

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

Secondary outcome [36]

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

Timepoint [36]

Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks

Secondary outcome [37]

Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16

Timepoint [37]

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

Secondary outcome [38]

Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [38]

Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks

Secondary outcome [39]

Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16

Timepoint [39]

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

Secondary outcome [40]

Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60

Timepoint [40]

Baseline, 18, 20, 24, 28, 36, 48 and 60 weeks

Secondary outcome [41]

Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16

Timepoint [41]

Weeks 2, 4, 8, 12, and 16

Secondary outcome [42]

Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [42]

Weeks 18, 20, 24, 28, 36, 48, and 60

Secondary outcome [43]

Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16

Timepoint [43]

Weeks 2, 4, 8, 12, and 16

Secondary outcome [44]

Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [44]

Weeks 18, 20, 24, 28, 36, 48, and 60

Secondary outcome [45]

Time to Achieve DAS28(CRP) LDA

Timepoint [45]

Approximately 16 weeks

Secondary outcome [46]

Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16

Timepoint [46]

Weeks 2, 4, 8, 12, and 16

Secondary outcome [47]

Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [47]

Weeks 18, 20, 24, 28, 36, 48, and 60

Secondary outcome [48]

Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16

Timepoint [48]

Weeks 2, 4, 8, 12, and 16

Secondary outcome [49]

Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [49]

Weeks 18, 20, 24, 28, 36, 48, and 60

Secondary outcome [50]

Time to Achieve DAPSA LDA

Timepoint [50]

Approximately 16 weeks

Secondary outcome [51]

Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16

Timepoint [51]

Weeks 2, 4, 8, 12, and 16

Secondary outcome [52]

Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [52]

Weeks 18, 20, 24, 28, 36, 48, and 60

Secondary outcome [53]

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

Timepoint [53]

Baseline, 4, 8, 12, and 16 weeks

Secondary outcome [54]

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

Timepoint [54]

Baseline, 20, 24, 28, 36, and 48 weeks

Secondary outcome [55]

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

Timepoint [55]

Weeks 4, 8, 12, and 16

Secondary outcome [56]

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

Timepoint [56]

Weeks 20, 24, 28, 36, and 48

Secondary outcome [57]

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

Timepoint [57]

Weeks 4, 8, 12, and 16

Secondary outcome [58]

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

Timepoint [58]

Weeks 20, 24, 28, 36, and 48

Secondary outcome [59]

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

Timepoint [59]

Weeks 4, 8, 12, and 16

Secondary outcome [60]

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

Timepoint [60]

Weeks 20, 24, 28, 36, and 48

Secondary outcome [61]

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

Timepoint [61]

Weeks 4, 8, 12, and 16

Secondary outcome [62]

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

Timepoint [62]

Weeks 20, 24, 28, 36, and 48

Secondary outcome [63]

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

Timepoint [63]

Baseline, 4, 8, 12, and 16 weeks

Secondary outcome [64]

Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline

Timepoint [64]

Baseline, 20, 24, 28, 36, and 48 weeks

Secondary outcome [65]

Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline

Timepoint [65]

Baseline, 4, 8, 12, and 16 weeks

Secondary outcome [66]

Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline

Timepoint [66]

Baseline, 20, 24, 28, 36, and 48 weeks

Secondary outcome [67]

Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline

Timepoint [67]

Baseline, 4, 8, 12, and 16 weeks

Secondary outcome [68]

Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline

Timepoint [68]

Baseline, 20, 24, 28, 36, and 48 weeks

Secondary outcome [69]

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16

Timepoint [69]

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

Secondary outcome [70]

Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60

Timepoint [70]

Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks

Secondary outcome [71]

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16

Timepoint [71]

Baseline, 4, and 16 weeks

Secondary outcome [72]

Change From Baseline in FACIT-Fatigue Scale Score at Week 48

Timepoint [72]

Baseline, Week 48

Secondary outcome [73]

Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16

Timepoint [73]

Baseline, 4, and 16 weeks

Secondary outcome [74]

Change From Baseline in MCS of the SF-36v2 at Week 48

Timepoint [74]

Baseline, Week 48

Secondary outcome [75]

Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16

Timepoint [75]

Baseline, 4, and 16 weeks

Secondary outcome [76]

Change From Baseline in PCS of the SF-36v2 at Week 48

Timepoint [76]

Baseline, Week 48

Eligibility

Key inclusion criteria

Key

- 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

Key

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Terminated

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

13/11/2019

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

18/03/2021

Sample size

Target

Accrual to date

Final

106

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment hospital [1]

Genesis Research Services - Broadmeadow

Recruitment hospital [2]

Rheumatology Research Unit - Maroochydore

Recruitment hospital [3]

Emeritus Research - Camberwell

Recruitment postcode(s) [1]

2292 - Broadmeadow

Recruitment postcode(s) [2]

4558 - Maroochydore

Recruitment postcode(s) [3]

3124 - Camberwell

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

California

Country [2]

United States of America

State/province [2]

Florida

Country [3]

United States of America

State/province [3]

Georgia

Country [4]

United States of America

State/province [4]

Kentucky

Country [5]

United States of America

State/province [5]

Maryland

Country [6]

United States of America

State/province [6]

Michigan

Country [7]

United States of America

State/province [7]

Minnesota

Country [8]

United States of America

State/province [8]

Missouri

Country [9]

United States of America

State/province [9]

New Jersey

Country [10]

United States of America

State/province [10]

North Carolina

Country [11]

United States of America

State/province [11]

Ohio

Country [12]

United States of America

State/province [12]

Pennsylvania

Country [13]

United States of America

State/province [13]

South Carolina

Country [14]

United States of America

State/province [14]

Texas

Country [15]

United States of America

State/province [15]

West Virginia

Country [16]

Belgium

State/province [16]

Yvoir

Country [17]

Canada

State/province [17]

Quebec

Country [18]

Czechia

State/province [18]

Pardubice

Country [19]

Czechia

State/province [19]

Uherske Hradiste

Country [20]

Hungary

State/province [20]

Budapest

Country [21]

Hungary

State/province [21]

Gyula

Country [22]

Hungary

State/province [22]

Szentes

Country [23]

Japan

State/province [23]

Hachioji-shi

Country [24]

Japan

State/province [24]

Kawachinagano

Country [25]

Japan

State/province [25]

Nagoya-City

Country [26]

Japan

State/province [26]

Nagoya

Country [27]

Japan

State/province [27]

Tokyo

Country [28]

Korea, Republic of

State/province [28]

Incheon

Country [29]

Korea, Republic of

State/province [29]

Seoul

Country [30]

Poland

State/province [30]

Bialystok, Podlaskie

Country [31]

Poland

State/province [31]

Dabrówka

Country [32]

Poland

State/province [32]

Gdansk

Country [33]

Poland

State/province [33]

Katowice

Country [34]

Poland

State/province [34]

Warsaw

Country [35]

Poland

State/province [35]

Warszawa, Mazowieckie

Country [36]

Poland

State/province [36]

Warszawa

Country [37]

Poland

State/province [37]

Wroclaw

Country [38]

Spain

State/province [38]

Fuenlabrada

Country [39]

Spain

State/province [39]

Madrid

Country [40]

Spain

State/province [40]

Sabadell

Country [41]

Spain

State/province [41]

Santander

Country [42]

Spain

State/province [42]

Sevilla

Country [43]

Spain

State/province [43]

Valencia

Country [44]

Taiwan

State/province [44]

Dailin Township

Country [45]

Taiwan

State/province [45]

Tainan

Country [46]

Taiwan

State/province [46]

Taipei

Funding & Sponsors

Primary sponsor type

Commercial sector/Industry

Name

Gilead Sciences

Address

Country

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Galapagos NV

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/ct2/show/NCT04115839

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Gilead Study Director

Address

Gilead Sciences

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04115839

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04115839