A Study Comparing an Active Drug to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug

Brief summary

This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of an active drug Dose A once daily (QD) and Dose B QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of an active drug Dose A QD and Dose B QD in subjects with PsA who have completed Period 1.

Interventional study

Active, not recruiting
Psoriatic Arthritis
642 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Eligibility criteria

Participant attributes:
Male and Female


18 Years and older.

Inclusion Criteria:

- Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening
Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria

- Participant has active disease at Baseline defined as >= 3 tender joints (based on 68
joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and
Baseline Visits

- Diagnosis of active plaque psoriasis or documented history of plaque psoriasis

- Participant has had an inadequate response (lack of efficacy after a minimum 12 week
duration of therapy) or intolerance to treatment with at least 1 bDMARD.

Exclusion Criteria:

- Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to
ruxolitinib, tofacitinib, baricitinib, and filgotinib)

- Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than
methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), apremilast,
hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with
LEF at Baseline.

- History of fibromyalgia, any arthritis with onset prior to age 17 years, or current
diagnosis of inflammatory joint disease other than PsA (including, but not limited to
rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma,
polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of
reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and
non-radiographic axial spondyloarthritis is permitted if documentation of change in
diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia
is permitted if documentation of change in diagnosis to PsA or documentation that the
diagnosis of fibromyalgia was made incorrectly.

All the cities where the clinical studies are located

Victoria - V8V 3M9
Barrie - L4M 6L2
Sainte-foy - G1V 3M7
Trois-rivières - G8Z 1Y2
Winnipeg - R3N 0K6

British Columbia



More information about this study