Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

Inclusion Criteria:

• Male or Female participants 5 to < 18 years of age at the time of randomization.

• Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:

  • Arthritis and psoriasis, OR
  • Arthritis with at least 2 of the following:
  • Dactylitis
  • Nail pitting or onycholysis
  • Psoriasis in a first-degree relative

• Active disease: at least 3 active joints.

• Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents).

Exclusion Criteria:

• Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:

  • Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
  • Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
  • History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
  • Presence of systemic juvenile idiopathic arthritis (JIA).

• Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.

• Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).