Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

• Status: Not yet recruiting
• Trial end date: 2025-12-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Apremilast

Criteria

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 (including distal interphalangeal 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, enthesitis-related arthritis, 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).