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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04115839
Ethics application status
Date submitted
2/10/2019
Date registered
4/10/2019
Date last updated
20/04/2021

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] 0 0
2019-002021-29
Secondary ID [2] 0 0
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 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
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 2 years.

Experimental: Filgotinib 100 mg (LTE) - Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 2 years.


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] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 - ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire - disability index (HAQ-DI), and an acute-phase reactant high sensitivity C-reactive protein (hsCRP).
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) - PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS covers the physician's global assessment of disease activity and participant's global assessment of disease activity, the Short-Form Health Survey (SF-36) Physical Component Score (PCS), swollen and tender joint counts, enthesitis and dactylitis, as well as hsCRP. A lower score indicates better function.
Timepoint [1] 0 0
Baseline; Weeks 4, 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) Response - Minimal disease activity will be determined by tender and swollen joint counts, PASI or BSA, participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Timepoint [2] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [3] 0 0
Percentage of Participants who Achieved Very Low Disease Activity (VLDA) Response - VLDA will be determined by tender and swollen joint counts, PASI or BSA, participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Timepoint [3] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [4] 0 0
Change from Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) - DAPSA is a psoriatic arthritis disease activity measure, calculated by summing swollen and tender joint counts, participant's assessment of pain, participant's global assessment of disease activity, and hsCRP.
Timepoint [4] 0 0
Baseline; Weeks 2, 4, 8, 12, 16
Secondary outcome [5] 0 0
Change from Baseline in Physician's Global Assessment of Psoriasis (PhGAP) in participants with psoriasis covering = 3% of the BSA at Baseline - The physician's global assessment of psoriasis is used to determine the participants's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician, using a 6-point scale, which ranges from 0 (cleared) to 5 (severe).
Timepoint [5] 0 0
Baseline; Weeks 2, 4, 8, 12, 16
Secondary outcome [6] 0 0
Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) in Participants with Psoriatic Nail Involvement at Baseline - Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Timepoint [6] 0 0
Baseline; Weeks 4, 8, 12, 16
Secondary outcome [7] 0 0
Change from Baseline in Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline - Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Timepoint [7] 0 0
Baseline; Weeks 4, 8, 12, 16
Secondary outcome [8] 0 0
Change from Baseline in 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) - The PsAID questionnaire assesses the impact of PsA on people's lives. It is a 12-item questionnaire, where each item will be scored between 0 and 10. All items are prioritized according to importance of the health domain it represents. A higher score on the PsAID indicates more impact of the disease.
Timepoint [8] 0 0
Baseline, Weeks 4, 16
Secondary outcome [9] 0 0
Percentage of Participants with PASDAS Low Disease Activity (LDA) - PASDAS LDA is defined as PASDAS = 3.2.
Timepoint [9] 0 0
Baseline; Weeks 4, 16
Secondary outcome [10] 0 0
Percentage of Participants who Achieve PASDAS Remission - PASDAS remission is defined as PASDAS = 1.9.
Timepoint [10] 0 0
Baseline; Weeks 4, 16
Secondary outcome [11] 0 0
Percentage of Participants who Achieve an American College of Rheumatology 20% Improvement Response at Week 12 - ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, patient assessment of pain, HAQ-DI and an acute-phase reactant high sensitivity C-reactive protein (hsCRP).
Timepoint [11] 0 0
Week 2, 4, 8, 16
Secondary outcome [12] 0 0
Percentage of Participants who Achieve an American College of Rheumatology 50% Improvement Response - ACR50 is calculated as an at least 50% improvement from baseline in both tender and swollen joint counts and an at least 50% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and an acute-phase reactant high sensitivity C-reactive protein (hsCRP).
Timepoint [12] 0 0
Weeks 2, 4, 8, 12, 16
Secondary outcome [13] 0 0
Percentage of Participants who Achieve an American College of Rheumatology 70% Improvement Response at Week 12 - ACR70 is calculated as a 70% improvement from baseline in both tender and swollen joint counts and a 70% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, patient assessment of pain, HAQ-DI and an acute-phase reactant high sensitivity C-reactive protein (hsCRP).
Timepoint [13] 0 0
Weeks 2, 4, 8, 12, 16
Secondary outcome [14] 0 0
Change from Baseline in Individual Components of the American College of Rheumatology Response Criteria - Components of ACR include tender and swollen joint counts, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and hsCRP.
Timepoint [14] 0 0
Baseline, Weeks 2, 4, 8, 12, 16
Secondary outcome [15] 0 0
Change from Baseline in Participants who Achieve Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) - DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity and hsCRP. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Timepoint [15] 0 0
Baseline, Weeks 2, 4, 8, 12, 16
Secondary outcome [16] 0 0
Percentage of Participants who Achieve DAS28(CRP) LDA - DAS28(CRP) LDA is defined as DAS28(CRP) = 3.2.
Timepoint [16] 0 0
Baseline, Weeks 2, 4, 8, 12, 16
Secondary outcome [17] 0 0
Percentage of Participants who Achieve Remission by DAS28(CRP) - DAS28(CRP) remission is defined as DAS28(CRP) < 2.6.
Timepoint [17] 0 0
Baseline, Weeks 2, 4, 8, 12, 16
Secondary outcome [18] 0 0
Time to Achieve DAS28(CRP) LDA - Time to achieve DAS28(CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28(CRP) LDA, or censored if a participant does not achieve DAS28(CRP) LDA or missing.
Timepoint [18] 0 0
First dose date up to 16 weeks
Secondary outcome [19] 0 0
Percentage of Participants who Achieve DAPSA LDA - DAPSA LDA is defined as DAPSA = 14.
Timepoint [19] 0 0
Baseline; Weeks 2, 4, 8, 12, 16
Secondary outcome [20] 0 0
Percentage of Participants who Achieve DAPSA Remission - DAPSA remission is defined as DAPSA = 4.
Timepoint [20] 0 0
Baseline; Weeks 2, 4, 8, 12, 16
Secondary outcome [21] 0 0
Time to Achieve DAPSA LDA - Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA, or censored if a participant does not achieve DAS28(CRP) LDA or missing.
Timepoint [21] 0 0
First dose date up to 16 weeks
Secondary outcome [22] 0 0
Percentage of Participants who Achieve Psoriatic Arthritis Response Criteria (PsARC) Response - PsARC consists of four components: assessment of joint tenderness and swelling utilizing 68/66 joint counts respectively, participant's global assessment of disease activity, and physician's global assessment of disease activity.
Timepoint [22] 0 0
Baseline; Weeks 2, 4, 8, 12, 16
Secondary outcome [23] 0 0
Change from Baseline in Psoriasis Area and Severity Index (PASI) in Participants with Psoriasis Covering = 3% of the BSA at Baseline - The PASI will be assessed in participants with psoriasis covering = 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Timepoint [23] 0 0
Baseline; Weeks 4, 8, 12, 16
Secondary outcome [24] 0 0
Percentage of Participants who Achieve Psoriasis Area and Severity Index 50% Improvement (PASI50) Response - The PASI50 will be assessed in participants with psoriasis covering = 3% of the BSA at Baseline. A PASI 50 response represents at least a 50% improvement from baseline in the PASI score.
Timepoint [24] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [25] 0 0
Percentage of Participants who Achieve Psoriasis Area and Severity Index 75% Improvement (PASI75) Response in Participants with Psoriasis Covering = 3% of the Body Surface Area (BSA) at Baseline - The PASI75 will be assessed in participants with Psoriasis covering = 3% of the BSA at Baseline. A PASI75 response represents at least a 75% improvement from baseline in the PASI score.
Timepoint [25] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [26] 0 0
Percentage of Participants who Achieve Psoriasis Area and Severity Index 90% Improvement (PASI90) Response - The PASI90 will be assessed in participants with psoriasis covering = 3% of the BSA at Baseline. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score.
Timepoint [26] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [27] 0 0
Percentage of Participants who Achieve Psoriasis Area and Severity Index 100% Improvement (PASI100) Response - The PASI100 will be assessed in participants with psoriasis covering = 3% of the BSA at Baseline. A PASI 100 response represents at least a 100% improvement from baseline in the PASI score.
Timepoint [27] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [28] 0 0
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at baseline - The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. Tenderness is quantified as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.
Timepoint [28] 0 0
Baseline; Weeks 4, 8, 12, 16
Secondary outcome [29] 0 0
Change from Baseline in Leeds Dactylitis Index (LDI) in Participants with Dactylitis at Baseline - The LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [no tenderness] to 3 [tender and withdrawn]. A higher LDI indicates worse dactylitis.
Timepoint [29] 0 0
Baseline; Weeks 4, 8, 12, 16
Secondary outcome [30] 0 0
Change from Baseline in Tender Dactylitis Count (TDC) - TDC will be assessed in participants with dactylitis at Baseline. TDC is a simple count based on the presence or absence of tender joints.
Timepoint [30] 0 0
Baseline; Weeks 4, 8, 12, 16
Secondary outcome [31] 0 0
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) - HAQ-DI is used to monitor the participant's self-assessed physical function or disability. This 20 -question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 function areas (getting dressed, arising, eating, walking, hygiene, reaching, gripping, and activities). HAQ-DI total score ranges from 0 to 3, with higher scores indicating greater dysfunction.
Timepoint [31] 0 0
Baseline; Weeks 2, 4, 8, 12, 16
Secondary outcome [32] 0 0
Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) - FACIT-Fatigue is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-Fatigue total score ranges 0 to 52. Higher scores represent better fatigue status.
Timepoint [32] 0 0
Baseline; Weeks 4, 16
Secondary outcome [33] 0 0
Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes SF-36 Version 2 - Composite endpoint of change from baseline in MCS and PCS scores in SF-36 Version 2. The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain will be scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Timepoint [33] 0 0
Baseline; Weeks 4, 16

Eligibility
Key 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 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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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 subject at
increased risk during study participation or circumstances which may make a subject
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 subject 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [3] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
West Virginia
Country [16] 0 0
Belgium
State/province [16] 0 0
Yvoir
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Czechia
State/province [18] 0 0
Pardubice
Country [19] 0 0
Czechia
State/province [19] 0 0
Uherske Hradiste
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Hungary
State/province [21] 0 0
Gyula
Country [22] 0 0
Hungary
State/province [22] 0 0
Szentes
Country [23] 0 0
Japan
State/province [23] 0 0
Hachioji-shi
Country [24] 0 0
Japan
State/province [24] 0 0
Kawachinagano
Country [25] 0 0
Japan
State/province [25] 0 0
Nagoya-City
Country [26] 0 0
Japan
State/province [26] 0 0
Nagoya
Country [27] 0 0
Japan
State/province [27] 0 0
Tokyo
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Incheon
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Poland
State/province [30] 0 0
Bialystok, Podlaskie
Country [31] 0 0
Poland
State/province [31] 0 0
Dabrówka
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Katowice
Country [34] 0 0
Poland
State/province [34] 0 0
Warsaw
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa, Mazowieckie
Country [36] 0 0
Poland
State/province [36] 0 0
Warszawa
Country [37] 0 0
Poland
State/province [37] 0 0
Wroclaw
Country [38] 0 0
Spain
State/province [38] 0 0
Fuenlabrada
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Sabadell
Country [41] 0 0
Spain
State/province [41] 0 0
Santander
Country [42] 0 0
Spain
State/province [42] 0 0
Sevilla
Country [43] 0 0
Spain
State/province [43] 0 0
Valencia
Country [44] 0 0
Taiwan
State/province [44] 0 0
Dailin Township
Country [45] 0 0
Taiwan
State/province [45] 0 0
Tainan
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Galapagos NV
Address [1] 0 0
Country [1] 0 0

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/show/NCT04115839
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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