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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 (PENGUIN 2)

Primary Purpose

Psoriatic Arthritis

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Filgotinib

Placebo to match filgotinib

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:

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 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.

Sites / Locations

Medvin Clinical Research
Omega Research Debary, LLC
San Marcus Research Clinic, Inc.
Arthritis Center, Inc.
Jefrey D. Lieberman, ND, P.C.
Bluegrass Community Research, Inc.
Klein & Associates, M.D., P.A.
Clinical Research Institute of Michigan, LLC
St. Paul Rheumatology, P.A.
Arthritis Consultants, Inc.
Atlantic Coast Research
Joint and Muscle Research Institute
Paramount Medical Research & Consulting, LLC
Clinical Research Source Inc
Altoona Center for Clinical Research
Arthritis Group, PC
PA Regional Center for Arthritis and Osteoporosis 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
CHU UCL Namur - Site Godinne
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
CCR Czech a.s.
Reumatologie a Osteologie MEDICAL PLUS s.r.o., Rezidence Hradebni, Obchodni 1507, Uherske Hradiste, 68601
Obudai Egeszsegugyi Centrum Kft.
Bekes Megeyi Kozponti Korhaz, Reumatologiai Osztaly
Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly
Tokyo Medical University Hachioji Medical Center
National Hospital Organization Osaka Minami Medical Center
Nagoya City University Hospital
Daido Clinic
Keio University Hospital
Inha University Hospital
Seoul National University Hospital
SMG - SNU Boramae Medical Center
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
NSZOZ Unica CR
Centrum Badan Klinicznych PI-House sp. z o.o
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Rheuma Medicus Zaklad Opieki Zdrowotnej
ARS RHEUMATICA Sp. Z.o.o.
Centrum Medyczne AMED Warszawa Targowek
Centrum Medyczne Oporow
Hospital Universitario de Fuenlabrada - Rheumatology Department, Camino Del Molino no 2, Fuenlabrada, Madrid, 28942
Hospital Universitario 12 de Octubre, Avenida de Cordoba, s/n, Madrid, Spain, 28041
Hospital Universitario La Paz. Paseo de la Castellana 261, Madrid, 28046
Corporacio Sanitaria Parc Tauli, Parc Tauli 1, Rheumatology Service, Sabadell, Barcelona, 08208
Hospital Universitario Marques de Valdecilla, Rheumatology Service, Avda. Valdecilla s/n, 39008
Hospital Universitario Virgen Macarena
Hospital Clinico Universitario de Valencia, Avenida Blasco Ibáñez, 17 Rheumatology Service, Valencia, Spain,
Buddhist Dalin Tzu Chi Hospital
Chi Mei Medical Center
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taipei Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Filgotinib 200 mg (Main Study)

Filgotinib 100 mg (Main Study)

Placebo (Main Study)

Filgotinib 200 mg (LTE)

Filgotinib 100 mg (LTE)

Arm Description

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

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

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

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

Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 44 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. The PASDAS includes the following components: 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)]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains used 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). The score of PASDAS ranges from 0-10, lower scores indicates better function. A negative change from baseline indicates improvement.

Change From Baseline in PASDAS at Week 48

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)]; 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 MDA Response at Weeks 20, 24, 28, 36, and 48

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

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.

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

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

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

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 PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline

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

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

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. The 12 NRS is focused on pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, anxiety, embarrassment, social life, and depression. 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.

Change From Baseline in PsAID-12 Score at Week 48

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

PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: 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)]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; LEI [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; TDC [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2.

Percentage of Participants With PASDAS LDA at Week 48

PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: 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)]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; LEI [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; TDC [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; CRP. The score of PASDAS ranges from 0-10, lower score 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. The PASDAS includes the following components: 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)]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; LEI [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; TDC [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9.

Percentage of Participants Who Achieved PASDAS Remission at Week 48

PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: 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)]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; LEI [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; TDC [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; CRP. The score of PASDAS ranges from 0-10, lower score 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 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60

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

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

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.

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

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

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

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 ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60

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

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: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60

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: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60

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: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60

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

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.

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

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) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60

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

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

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

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

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

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. DAPSA LDA is defined as DAPSA ≤ 14. 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 was 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.

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

Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline

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.

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

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% 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 PASI50 Response at Weeks 20, 24, 28, 36, and 48 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 PASI75 Response at Weeks 20, 24, 28, 36, and 48 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 PASI90 Response at Weeks 20, 24, 28, 36, and 48 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.

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

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

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. 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. LDI measures the ratio of the circumference of affected digit to circumference of digit on contralateral hand or foot using a Leeds Dactylometer. LDI score is calculated based on circumference of the dactylitic finger/toe (mm), circumference of the contralateral digit (mm), tenderness score (0 = no tenderness, 1 = tender). Tenderness of affected digits is assessed on a scale from 0 (no tenderness) to 3 (tender and withdrawn). A higher LDI indicates worse dactylitis. Negative change from baseline indicates improvement.

Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 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. 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. LDI measures the ratio of the circumference of affected digit to circumference of digit on contralateral hand or foot using a Leeds Dactylometer. LDI score is calculated based on the circumference of the dactylitic finger/toe (mm), circumference of contralateral digit (mm), tenderness score (0 = no tenderness, 1 = tender). Tenderness of affected digits is assessed on a scale from 0 (no tenderness) to 3 (tender and withdrawn). A higher LDI indicates worse dactylitis. 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 TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline

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 HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60

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 FACIT-Fatigue Scale Score at Week 48

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 better quality of life. 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 MCS of the SF-36v2 at Week 48

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).

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

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

NCT04115839

First Posted

October 2, 2019

Last Updated

February 18, 2022

Sponsor

Gilead Sciences

Collaborators

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT04115839

Brief 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

Acronym

PENGUIN 2

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

Development program terminated

Study Start Date

November 13, 2019 (Actual)

Primary Completion Date

January 4, 2021 (Actual)

Study Completion Date

March 18, 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 have an inadequate response or are intolerant to biologic disease-modifying anti-rheumatic drugs (DMARD) therapy.

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

106 (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 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 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 for up to 16 weeks.

Arm Title

Filgotinib 200 mg (LTE)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Filgotinib

Other Intervention Name(s)

GS-6034, GLPG0634

Intervention Description

Tablets will be administered orally once daily with or without food.

Intervention Type

Drug

Intervention Name(s)

Placebo to match filgotinib

Intervention Description

Tablets administered orally once daily with or without food.

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

Change From Baseline in PASDAS at Week 48

Description

Time Frame

Baseline, Week 48

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 MDA Response at Weeks 20, 24, 28, 36, and 48

Description

Time Frame

Weeks 20, 24, 28, 36, and 48

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

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

Description

Time Frame

Weeks 20, 24, 28, 36, and 48

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

Description

Time Frame

Baseline, 18, 20, 24, 28, 36, 48, and 60 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 PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline

Description

Time Frame

Baseline, 18, 20, 24, 28, 36, and 48 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 mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline

Description

Time Frame

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

Description

Time Frame

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

Change From Baseline in PsAID-12 Score at Week 48

Description

Time Frame

Baseline, Week 48

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. The PASDAS includes the following components: 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)]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; LEI [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; TDC [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2.

Time Frame

Weeks 4 and 16

Title

Percentage of Participants With PASDAS LDA at Week 48

Description

PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: 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)]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; LEI [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; TDC [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2.

Time Frame

Week 48

Title

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

Description

PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: 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)]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; LEI [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; TDC [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9.

Time Frame

Weeks 4 and 16

Title

Percentage of Participants Who Achieved PASDAS Remission at Week 48

Description

PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS includes the following components: 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)]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains used to determine a PCS with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; LEI [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; TDC [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; CRP. The score of PASDAS ranges from 0-10, lower score indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9.

Time Frame

Week 48

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 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Percentage of Participants Who Achieve 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

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

Description

Time Frame

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

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

Description

Time Frame

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

Description

Time Frame

Baseline, 18, 20, 24, 28, 36, 48, and 60 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: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60

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, 18, 20, 24, 28, 36, 48, and 60 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: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60

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, 18, 20, 24, 28, 36, 48, and 60 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: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60

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

Description

Time Frame

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

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

Description

Time Frame

Baseline, 18, 20, 24, 28, 36, 48 and 60 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) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60

Description

Time Frame

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

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

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

Description

Time Frame

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

Title

Time to Achieve DAS28(CRP) LDA

Description

Time Frame

Approximately 16 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 LDA at Weeks 18, 20, 24, 28, 36, 48, and 60

Description

Time Frame

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

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

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

Description

Time Frame

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

Title

Time to Achieve DAPSA LDA

Description

Time Frame

Approximately 16 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

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

Description

Time Frame

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

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

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

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, 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% 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.

Time Frame

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

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

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 20, 24, 28, 36, and 48

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

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

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 20, 24, 28, 36, and 48

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

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

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 20, 24, 28, 36, and 48

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

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

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 20, 24, 28, 36, and 48

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

Description

Time Frame

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

Description

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. LDI measures the ratio of the circumference of affected digit to circumference of digit on contralateral hand or foot using a Leeds Dactylometer. LDI score is calculated based on the circumference of the dactylitic finger/toe (mm), circumference of contralateral digit (mm), tenderness score (0 = no tenderness, 1 = tender). Tenderness of affected digits is assessed on a scale from 0 (no tenderness) to 3 (tender and withdrawn). A higher LDI indicates worse dactylitis. Negative change from baseline indicates improvement.

Time Frame

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

Description

Time Frame

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

Description

Time Frame

Baseline, 18, 20, 24, 28, 36, 48, and 60 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 FACIT-Fatigue Scale Score at Week 48

Description

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 better quality of life. Positive change in value indicates improvement (no or less severity of fatigue).

Time Frame

Baseline, Week 48

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 MCS of the SF-36v2 at Week 48

Description

Time Frame

Baseline, Week 48

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

Title

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

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, Week 48

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: 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 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.

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

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

Arthritis Center, Inc.

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

85234

Country

United States

Facility Name

Jefrey D. Lieberman, ND, P.C.

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Bluegrass Community Research, Inc.

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

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

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

Arthritis Group, PC

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19152

Country

United States

Facility Name

PA Regional Center for Arthritis and Osteoporosis Research

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

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

CHU UCL Namur - Site Godinne

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

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

City

Quebec

ZIP/Postal Code

G1V3M7

Country

Canada

Facility Name

CCR Czech a.s.

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Reumatologie a Osteologie MEDICAL PLUS s.r.o., Rezidence Hradebni, Obchodni 1507, Uherske Hradiste, 68601

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

Obudai Egeszsegugyi Centrum Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Bekes Megeyi Kozponti Korhaz, Reumatologiai Osztaly

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly

City

Szentes

ZIP/Postal Code

6600

Country

Hungary

Facility Name

Tokyo Medical University Hachioji Medical Center

City

Hachioji-shi

ZIP/Postal Code

193-0998

Country

Japan

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

Inha University Hospital

City

Incheon

ZIP/Postal Code

22332

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

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

City

Bialystok, Podlaskie

ZIP/Postal Code

15-099

Country

Poland

Facility Name

NSZOZ Unica CR

City

Dabrówka

ZIP/Postal Code

62096

Country

Poland

Facility Name

Centrum Badan Klinicznych PI-House sp. z o.o

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddzial w Katowicach

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Rheuma Medicus Zaklad Opieki Zdrowotnej

City

Warsaw

ZIP/Postal Code

02-118

Country

Poland

Facility Name

ARS RHEUMATICA Sp. Z.o.o.

City

Warszawa, Mazowieckie

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Centrum Medyczne AMED Warszawa Targowek

City

Warszawa

ZIP/Postal Code

03-921

Country

Poland

Facility Name

Centrum Medyczne Oporow

City

Wroclaw

ZIP/Postal Code

52-416

Country

Poland

Facility Name

Hospital Universitario de Fuenlabrada - Rheumatology Department, Camino Del Molino no 2, Fuenlabrada, Madrid, 28942

City

Fuenlabrada

ZIP/Postal Code

28942

Country

Spain

Facility Name

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

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario La Paz. Paseo de la Castellana 261, Madrid, 28046

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Corporacio Sanitaria Parc Tauli, Parc Tauli 1, Rheumatology Service, Sabadell, Barcelona, 08208

City

Sabadell

ZIP/Postal Code

8208

Country

Spain

Facility Name

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

Hospital Clinico Universitario de Valencia, Avenida Blasco Ibáñez, 17 Rheumatology Service, Valencia, Spain,

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Buddhist Dalin Tzu Chi Hospital

City

Dailin Township

ZIP/Postal Code

622

Country

Taiwan

Facility Name

Chi Mei Medical Center

City

Tainan

ZIP/Postal Code

71004

Country

Taiwan

Facility Name

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

City

Taipei

ZIP/Postal Code

10507

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 Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy

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