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Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy (PENGUIN 1)

Primary Purpose

Psoriatic Arthritis

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Filgotinib

Adalimumab

Placebo to match filgotinib

Placebo to match adalimumab

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medvin Clinical Research
Bay Area Arthritis and Osteoporosis
Omega Research Debary, LLC
San Marcus Research Clinic, Inc.
Hmd Research Llc
Arthritis Center, Inc.
ForCare Clinical Research
BayCare Medical Group, Inc.
North Georgia Rheumatology Group
Klein & Associates, M.D., P.A.
Clinical Research Institute of Michigan, LLC
St. Paul Rheumatology, P.A.
Arthritis Consultants, Inc.
Physician Research Collaaboration, LLCs
Atlantic Coast Research
Joint and Muscle Research Institute
Paramount Medical Research & Consulting, LLC
Clinical Research Source Inc
Altoona Center for Clinical Research
Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA
ACME Research, LLC
Arthritis & Osteoporosis Clinic of Brazos Valley (Drug Shipment Address)
Southwest Rheumatology Research, LLC
West Virginia Research Institute PLLC
Genesis Research Services
Rheumatology Research Unit
Emeritus Research
University Multiprofile Hospital for Active Treatment - Plovdiv AD, Department Of Rheumatology
Multiprofile Hospital for Active Treatment "Lyulin" EAD, Department of Rheumatology
Diagnostic consultative center 17 Sofia EOOD
"Medical center Synexus Sofia" EOOD
"Medical center SYNEXUS SOFIA" EOOD, branch Stara Zagora
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
CCR Ostrava, s.r.o.
Synexus (DRS) - Synexus Magyarorszag Kft. Budapest
Synexus (DRS) - Synexus Magyarorszag Kft. Gyula
National Hospital Organization Osaka Minami Medical Center
Nagoya City University Hospital
Daido Clinic
Keio University Hospital
CHA Bundang Medical Center, CHA University
Seoul National University Hospital
SMG - SNU Boramae Medical Center
Waikato Hospital
Optimal Clinical Trials
Capital & Coast District Health Board
Clinical Trials Unit, Timaru Hospital
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Szpital Uniwersytecki nr 2 im. dr Jana Biziela
NSZOZ Unica CR
Centrum Medyczne Pratia Gdynia
Malopolskie Badania Kliniczne SP Z O O Sp. k.
NZOZ Lecznica MAK-MED s.c.
ETYKA Osrodek Badan Klinicznych
Pheuma Medicus Zaklad Opieki Zdrowotnej
ARS RHEUMATICA Sp. Z.o.o., "REUMATIKA-Centrum Reumatologii", NZOZ
Medycyna Kliniczna Marzena Waszczak-Jeka
Centrum Medyczne AMED Warszawa
REUMATOLOG WARSZAWA Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler
Centrum Medyczne Oporow
Ulitsa Delegatskaya, 20, Building 1, Ulitsa Kasatkina, 7 Moscow, Russia, 127473/129301
LLC "Biomed"
Center for medical advice and research - PRACTICE LTD
Hospital Universitario 12 de Octubre, Avenida de Cordoba s/n, Rheumatology Service, Madrid, Spain, 28041
Corporacio Sanitaria Parc Tauli
Hospital Universitario Marques de Valdecilla, Rheumatology Service, Avda. Valdecilla s/n, Santander, Cantabria, 39008
Hospital Universitario Virgen Macarena
Buddhist Dalin Tzu Chi Hospital
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital
Far Eastern Memorial Hospital
National Cheng Kung University Hospital
Chi Mei Medical Center
Taipei Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Arm Label

Filgotinib 200 mg (Main Study)

Filgotinib 100 mg (Main Study)

Adalimumab (Main Study)

Placebo (Main Study)

Filgotinib 200 mg (Long Term Extension [LTE])

Filgotinib 100 mg (LTE)

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA [using VAS on a scale of 0=very well to 100=very poor]; PhGADA [using VAS on a scale of 0=no disease activity to 100=maximum disease activity];36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status];TJC68;SJC66; leeds enthesitis index(LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis];Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis];C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. A negative change from baseline indicates improvement.

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

MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC68 ≤1; SJC66 ≤1; Psoriatic arthritis disease activity score (PASI) ≤1 for participants with psoriasis covering BSA <3% [PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)]; patient's global assessment of PsA pain intensity (PGAPI) ≤15 [using VAS on a scale of 0 (no pain) to 100 (serious pain)]; PGADA ≤20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score ≤0.5; LEI score ≤1 for participants with enthesitis at baseline.

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

VLDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the VLDA if the participant fulfills all the seven criteria: TJC68 ≤1; SJC66 ≤1; PASI score ≤1 for participants with psoriasis covering BSA <3% [PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)]; PGAPI ≤15 [using VAS on a scale of 0 (no pain) to (serious pain)]; PGADA ≤20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score ≤0.5; LEI score ≤1 with participants with enthesitis at baseline.

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

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

The PhGAP is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity is assessed by a physician according to the grades of induration, erythema, and scaling on a scale of 0 to 5. The sum of the three grades is used to obtain the total average score. PhGAP is based on the total average score on a scale of 0-5 where, 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. A negative change from baseline indicates improvement.

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

mNAPSI is used to assess each nail abnormality for each of the participant's nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail are graded on a scale from 0 (no onycholysis together with oil-drop dyschromia, no pitting, no crumbling) to 3 (>30 onycholysis together with oil-drop dyschromia, >50 pitting, >50% crumbling). Four features (leukonychia, splinter, hemorrhages, hyperkeratosis, and red spots in the lunula) are graded with the score of 1 = present or 0 = absent for each fingernail. Each finger has a score between 0 and 13. The total mNAPSI score is the sum of all abnormalities individual score across all fingers, and the total mNAPSI score ranges from 0 to 130. Lower numbers indicate fewer nail abnormalities. A negative change from baseline indicates improvement.

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

Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. A negative change from baseline indicates improvement.

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

The PsAID questionnaire assesses the impact of PsA on people's lives. The PsAID is calculated based on 12 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10. Total score is calculated as the sum of the individual scores, (some of which were multiplied by a weighting factor) divided by 20 for a total possible score of 0 to 10, where higher score indicates worse impact of disease. A negative change from baseline indicates improvement.

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

PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA [using VAS on a scale of 0=very well to 100=very poor]; PhGADA [using VAS on a scale of 0=no disease activity to 100=maximum disease activity]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; leeds enthesitis index(LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2.

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

PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA [using VAS on a scale of 0=very well to 100=very poor]; PhGADA [using VAS on a scale of 0=no disease activity to 100=maximum disease activity]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status];TJC68;SJC66; leeds enthesitis index(LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9.

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

ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); 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 hsCRP. Participants with missing outcomes were set as non-responders.

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

ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); 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 hsCRP. Participants with missing outcomes were set as non-responders.

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

ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); 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 hsCRP. Participants with missing outcomes were set as non-responders.

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

TJC68 is an assessment of 68 joints. Each joint is evaluated as 'normal', 'tender', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all tender joints. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement.

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

SJC66 is an assessment of 66 joints. Each joint was evaluated as 'normal', 'swollen', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all swollen joints. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement.

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

PGADA is assessed by the participants using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement.

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

PhGADA is assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.

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

HAQ-DI's pain assessment is done using VAS on a scale of 0 (no pain) to 100 (serious pain). A negative change from baseline indicates improvement.

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

The hsCRP is the ACR core set measure of acute phase reactant. It was measured at the central laboratory to help assess the effect of filgotinib on the participant's psoriatic arthritis. A negative change from baseline indicates improvement.

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

The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA [using a VAS on a scale of 0 (very well) to 100 (very poor)] and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.

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

The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28(CRP) ≤ 3.2.

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

Time to Achieve DAS28 (CRP) LDA

The DAS28 (CRP) is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28 (CRP) ≤ 3.2. 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.

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

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

Time to Achieve DAPSA LDA

DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA [using VAS on a scale of 0 (very well) to 100 very poor)]; PGAPI [using a VAS on a scale of 0 (no pain) to 100 (serious pain)] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and >28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. 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. If the DAPSA LDA is not achieved during main study phase, the time to achieve DAPSA LDA will be censored at the last non-missing DAPSA LDA assessment date during main study phase. If the component scores of DAPSA LDA are at different dates for a visit, the latest date will be used for the derivation of time to achieve DAPSA LDA.

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

The PsARC response is defined as improvement in at least 2 of the following 4 criteria; ≥ 30% decrease in SJC66, ≥ 30% decrease in TJC68, ≥ 20% decrease in PGADA (VAS; 0 = very well to 100 = very poor), ≥ 20% decrease in PhGADA (VAS; 0 = no disease activity to 100 = maximum disease activity), and with at least one of the 2 joint criteria, with no deterioration in any other criteria.

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

PASI is 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 and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, where 0 = none, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A higher score indicates more severe disease. A negative change from baseline indicates improvement.

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

PASI is 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 and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI50, the improvement threshold from baseline in PASI score is 50%. A higher score indicates more severe disease.

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

PASI is 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 and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease.

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

PASI is 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 and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI90, the improvement threshold from baseline in PASI score is 90%. A higher score indicates more severe disease.

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

PASI is 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 and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI100, the improvement threshold from baseline in PASI score is 100%. A higher score indicates more severe disease.

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

The enthesitis examination is based on the 16 anatomical sites: the medial epicondyle (left and right), the lateral epicondyle (left and right), the supraspinatus insertion (left and right), the bilateral greater trochanter (left and right), the quadriceps tendon insertion into superior border of patella (left and right), the patellar ligament insertion into inferior pole of patella or tibial tuberosity (left and right), the achilles tendon insertion (left and right), and the plantar fascia insertion (left and right). Enthesitis at each site is scored as either 0 (enthesitis absent) and 1 (enthesitis present). SPARCC enthesitis index has an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. A negative change from baseline indicates improvement.

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

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 (digit on opposite hand or foot), or if contralateral digit is also affected, values from a standard reference table. Total score= {{[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1}x 100} x Tenderness score. Tenderness score (0 = no tenderness, and 1 = tender). The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index. Lower Leeds Dactylitis Index score represent better outcome. A negative change from baseline indicates improvement.

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

Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of LDI total score. Tender dactylitis count (TDC) equals the number of tender fingers and toes (tendor score >0). For participants with dactylitis status absent for all the fingers and toes, the TDC is set as 0. The total score range of TDC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement.

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

The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. A negative change from baseline indicates improvement (less disability).

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

FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Higher scores indicate less fatigue. Positive change in value indicates improvement (no or less severity of fatigue).

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

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. Each domain is 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. A positive change from baseline indicated improvement (better health status).

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

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). PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is 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. A positive change from baseline indicates improvement (better health status).

Full Information

NCT ID

NCT04115748

First Posted

October 2, 2019

Last Updated

April 21, 2022

Sponsor

Gilead Sciences

Collaborators

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT04115748

Brief Title

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

Acronym

PENGUIN 1

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

Development program terminated

Study Start Date

December 3, 2019 (Actual)

Primary Completion Date

January 19, 2021 (Actual)

Study Completion Date

May 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

Collaborators

Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Filgotinib 200 mg (Main Study)

Arm Type

Experimental

Arm Description

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

Arm Title

Filgotinib 100 mg (Main Study)

Arm Type

Experimental

Arm Description

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

Arm Title

Adalimumab (Main Study)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo (Main Study)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Filgotinib 200 mg (Long Term Extension [LTE])

Arm Type

Experimental

Arm Description

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

Arm Title

Filgotinib 100 mg (LTE)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Filgotinib

Other Intervention Name(s)

GS-6034, GLPG0634

Intervention Description

Tablets administered orally once daily with or without food

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Intervention Description

Injection administered subcutaneously once every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo to match filgotinib

Intervention Description

Tablets administered orally once daily with or without food

Intervention Type

Drug

Intervention Name(s)

Placebo to match adalimumab

Intervention Description

Injection administered subcutaneously once every 2 weeks

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, 4, and 16 weeks

Title

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

Description

Time Frame

Weeks 4, 8, 12, and 16

Title

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

Description

Time Frame

Weeks 4, 8, 12, and 16

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Baseline, 4, 8, 12, and 16 weeks

Title

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

Description

Time Frame

Baseline, 4, 8, 12, and 16 weeks

Title

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

Description

Time Frame

Baseline, 4, and 16 weeks

Title

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

Description

PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA [using VAS on a scale of 0=very well to 100=very poor]; PhGADA [using VAS on a scale of 0=no disease activity to 100=maximum disease activity]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; leeds enthesitis index(LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2.

Time Frame

Weeks 4, and 16

Title

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

Description

PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA [using VAS on a scale of 0=very well to 100=very poor]; PhGADA [using VAS on a scale of 0=no disease activity to 100=maximum disease activity]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status];TJC68;SJC66; leeds enthesitis index(LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9.

Time Frame

Weeks 4, and 16

Title

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

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

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

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

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

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

PGADA is assessed by the participants using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement.

Time Frame

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

Title

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

Description

PhGADA is assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.

Time Frame

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

Title

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

Description

HAQ-DI's pain assessment is done using VAS on a scale of 0 (no pain) to 100 (serious pain). A negative change from baseline indicates improvement.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

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

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Time to Achieve DAS28 (CRP) LDA

Description

Time Frame

Up to 19 weeks

Title

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

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

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

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

Time to Achieve DAPSA LDA

Description

Time Frame

Up to 19 weeks

Title

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

Description

Time Frame

Weeks 2, 4, 8, 12, and 16

Title

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

Description

Time Frame

Baseline, 4, 8, 12, and 16 weeks

Title

Description

PASI is 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 and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI50, the improvement threshold from baseline in PASI score is 50%. A higher score indicates more severe disease.

Time Frame

Weeks 4, 8, 12, and 16

Title

Description

PASI is 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 and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease.

Time Frame

Weeks 4, 8, 12, and 16

Title

Description

PASI is 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 and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI90, the improvement threshold from baseline in PASI score is 90%. A higher score indicates more severe disease.

Time Frame

Weeks 4, 8, 12, and 16

Title

Description

PASI is 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 and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI100, the improvement threshold from baseline in PASI score is 100%. A higher score indicates more severe disease.

Time Frame

Weeks 4, 8, 12, and 16

Title

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

Description

Time Frame

Baseline, 4, 8, 12, and 16 weeks

Title

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

Description

Time Frame

Baseline, 4, 8, 12, and 16 weeks

Title

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

Description

Time Frame

Baseline, 4, 8, 12, and 16 weeks

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Baseline, 4, and 16 weeks

Title

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

Description

Time Frame

Baseline, 4, and 16 weeks

Title

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

Description

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). PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is 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. A positive change from baseline indicates improvement (better health status).

Time Frame

Baseline, 4, and 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Medvin Clinical Research

City

Covina

State/Province

California

ZIP/Postal Code

91723

Country

United States

Facility Name

Bay Area Arthritis and Osteoporosis

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Omega Research Debary, LLC

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Facility Name

San Marcus Research Clinic, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Hmd Research Llc

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Arthritis Center, Inc.

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

85234

Country

United States

Facility Name

ForCare Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

BayCare Medical Group, Inc.

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

North Georgia Rheumatology Group

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Klein & Associates, M.D., P.A.

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Clinical Research Institute of Michigan, LLC

City

Saint Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

St. Paul Rheumatology, P.A.

City

Eagan

State/Province

Minnesota

ZIP/Postal Code

55121

Country

United States

Facility Name

Arthritis Consultants, Inc.

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Physician Research Collaaboration, LLCs

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Atlantic Coast Research

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Joint and Muscle Research Institute

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Paramount Medical Research & Consulting, LLC

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Clinical Research Source Inc

City

Perrysburg

State/Province

Ohio

ZIP/Postal Code

43551

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

ACME Research, LLC

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Arthritis & Osteoporosis Clinic of Brazos Valley (Drug Shipment Address)

City

College Station

State/Province

Texas

ZIP/Postal Code

77845

Country

United States

Facility Name

Southwest Rheumatology Research, LLC

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

West Virginia Research Institute PLLC

City

South Charleston

State/Province

West Virginia

ZIP/Postal Code

25309

Country

United States

Facility Name

Genesis Research Services

City

Broadmeadow

State/Province

New South Wales

ZIP/Postal Code

2292

Country

Australia

Facility Name

Rheumatology Research Unit

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Emeritus Research

City

Camberwell

State/Province

Victoria

ZIP/Postal Code

3124

Country

Australia

Facility Name

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

City

Plovdiv

ZIP/Postal Code

4003

Country

Bulgaria

Facility Name

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

City

Sofia

ZIP/Postal Code

1336

Country

Bulgaria

Facility Name

Diagnostic consultative center 17 Sofia EOOD

City

Sofia

ZIP/Postal Code

1505

Country

Bulgaria

Facility Name

"Medical center Synexus Sofia" EOOD

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

"Medical center SYNEXUS SOFIA" EOOD, branch Stara Zagora

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

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

City

Quebec

ZIP/Postal Code

G1V3M7

Country

Canada

Facility Name

CCR Ostrava, s.r.o.

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Synexus (DRS) - Synexus Magyarorszag Kft. Budapest

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Synexus (DRS) - Synexus Magyarorszag Kft. Gyula

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

National Hospital Organization Osaka Minami Medical Center

City

Kawachinagano

ZIP/Postal Code

586-8521

Country

Japan

Facility Name

Nagoya City University Hospital

City

Nagoya-City

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Daido Clinic

City

Nagoya

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

Keio University Hospital

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

CHA Bundang Medical Center, CHA University

City

Seongnam

ZIP/Postal Code

13496

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

SMG - SNU Boramae Medical Center

City

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

Facility Name

Waikato Hospital

City

Hamilton

State/Province

WKO

ZIP/Postal Code

3240

Country

New Zealand

Facility Name

Optimal Clinical Trials

City

Auckland

ZIP/Postal Code

1010

Country

New Zealand

Facility Name

Capital & Coast District Health Board

City

Newtown

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

Clinical Trials Unit, Timaru Hospital

City

Timaru

ZIP/Postal Code

7910

Country

New Zealand

Facility Name

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

City

Bialystok, Podlaskie

ZIP/Postal Code

15-099

Country

Poland

Facility Name

Szpital Uniwersytecki nr 2 im. dr Jana Biziela

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

NSZOZ Unica CR

City

Dabrówka

ZIP/Postal Code

62096

Country

Poland

Facility Name

Centrum Medyczne Pratia Gdynia

City

Gdynia

ZIP/Postal Code

81-338

Country

Poland

Facility Name

Malopolskie Badania Kliniczne SP Z O O Sp. k.

City

Krakow

ZIP/Postal Code

30-349

Country

Poland

Facility Name

NZOZ Lecznica MAK-MED s.c.

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

ETYKA Osrodek Badan Klinicznych

City

Olsztyn

ZIP/Postal Code

10-117

Country

Poland

Facility Name

Pheuma Medicus Zaklad Opieki Zdrowotnej

City

Warsaw

ZIP/Postal Code

02-118

Country

Poland

Facility Name

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

City

Warszawa, Mazowieckie

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Medycyna Kliniczna Marzena Waszczak-Jeka

City

Warszawa

ZIP/Postal Code

00-874

Country

Poland

Facility Name

Centrum Medyczne AMED Warszawa

City

Warszawa

ZIP/Postal Code

03-921

Country

Poland

Facility Name

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

City

Warszawa

ZIP/Postal Code

04-305

Country

Poland

Facility Name

Centrum Medyczne Oporow

City

Wroclaw

ZIP/Postal Code

52-416

Country

Poland

Facility Name

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

City

Moskva

ZIP/Postal Code

127473

Country

Russian Federation

Facility Name

LLC "Biomed"

City

Vladimir

ZIP/Postal Code

600005

Country

Russian Federation

Facility Name

Center for medical advice and research - PRACTICE LTD

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

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

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Corporacio Sanitaria Parc Tauli

City

Sabadell

ZIP/Postal Code

8208

Country

Spain

Facility Name

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

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41007

Country

Spain

Facility Name

Buddhist Dalin Tzu Chi Hospital

City

Dailin Township

ZIP/Postal Code

622

Country

Taiwan

Facility Name

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital

City

Keelung

ZIP/Postal Code

204

Country

Taiwan

Facility Name

Far Eastern Memorial Hospital

City

New Taipei City

ZIP/Postal Code

220

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Chi Mei Medical Center

City

Tainan

ZIP/Postal Code

71004

Country

Taiwan

Facility Name

Taipei Medical University Hospital

City

Taipei

ZIP/Postal Code

11031

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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