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
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Filgotinib; Placebo to match filgotinib
Intervention description: Tablets will be administered orally once daily with or without food.; Tablets administered orally once daily with or without food.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

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.