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

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Psoriatic Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04115748

GS-US-431-4566

JapicCTI-205202 (Registry Identifier)

2019-001996-35 (EudraCT Number)

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 are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).

Enrollment: 67 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and have a history consistent with psoriatic arthritis (PsA) ≥ 6 months at Screening

• Have active PsA defined as ≥ 3 swollen joints (from a 66 swollen joint count [SJC]) and ≥ 3 tender joints (from a 68 tender joint count [TJC]) at Screening and Day 1; these may or may not be the same joints at Screening and Day 1

• Must have a documented history or active signs of at least one of the following at Screening:

  • Plaque psoriasis
  • Nail changes attributed to psoriasis

• Have had inadequate response or intolerance to ≥1 conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), apremilast and / or NSAID, administered over the course of ≥ 12 weeks for the treatment of PsA, as per local guidelines / standard of care

Key Exclusion Criteria:

• Prior PsA or psoriasis treatment with a biologic DMARD
• Prior exposure to a janus kinase (JAK) inhibitor > 2 doses
• Any active / recent infection
• Any chronic and / or uncontrolled medical condition that would put the individual at increased risk during study participation or circumstances which may make an individual unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement
• Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of investigator

NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA

• Any history of an inflammatory arthropathy with onset before age 16 years old
• Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the individual by participating in the study (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator
• Pregnancy or nursing females
• Active drug or alcohol abuse, as per judgement of investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 6 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 + PTM adalimumab injection for up to 16 weeks.

Treatment:

Drug: Filgotinib

Drug: Placebo to match adalimumab

Drug: Placebo to match filgotinib

Filgotinib 100 mg (Main Study)

Experimental group

Description:

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

Treatment:

Drug: Filgotinib

Drug: Placebo to match adalimumab

Drug: Placebo to match filgotinib

Adalimumab (Main Study)

Active Comparator group

Description:

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

Treatment:

Drug: Adalimumab

Drug: Placebo to match filgotinib

Placebo (Main Study)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to match adalimumab

Drug: Placebo to match filgotinib

Filgotinib 200 mg (Long Term Extension [LTE])

Experimental group

Description:

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

Treatment:

Drug: Filgotinib

Drug: Placebo to match filgotinib

Filgotinib 100 mg (LTE)

Experimental group

Description:

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

Treatment:

Drug: Filgotinib

Drug: Placebo to match filgotinib