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)

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Placebo to match filgotinib; Drug: Filgotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04115839

JapicCTI-205201 (Registry Identifier)

2019-002021-29 (EudraCT Number)

GS-US-431-4567

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 5 patient groups, including a placebo group

Filgotinib 200 mg (Main Study)

Experimental group

Description:

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

Treatment:

Drug: Placebo to match filgotinib

Drug: Filgotinib

Filgotinib 100 mg (Main Study)

Experimental group

Description:

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

Treatment:

Drug: Placebo to match filgotinib

Drug: Filgotinib

Placebo (Main Study)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to match filgotinib

Filgotinib 200 mg (LTE)

Experimental group

Description:

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

Treatment:

Drug: Placebo to match filgotinib

Drug: Filgotinib

Filgotinib 100 mg (LTE)

Experimental group

Description:

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

Treatment:

Drug: Placebo to match filgotinib

Drug: Filgotinib