Actively Recruiting
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children 5 to Less Than 18 Years with Active Juvenile Psoriatic Arthritis
Led by Amgen · Updated on 2026-04-20
60
Participants Needed
45
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of apremilast compared with a placebo in treating juvenile psoriatic arthritis JPsA in children aged 5 to less than 18 years. This phase 3 study aims to understand how well apremilast works in this pediatric population with active disease who have not responded adequately to other treatments. Participants will be randomly assigned to receive either apremilast or a matching placebo orally during a 16-week double-blind treatment phase. After this, all participants will continue on apremilast for an additional 36 weeks in an active treatment phase. The study is designed to compare responses between the apremilast and placebo groups during the initial phase and then monitor all participants while on apremilast. Throughout the study, participants will be assessed for improvements in arthritis symptoms using criteria such as the American College of Rheumatology Pediatric ACR Pedi response at week 16. Researchers will also monitor pain levels, joint function, inflammation markers, and overall well-being. Safety will be evaluated by tracking adverse events and changes in growth and development parameters over the 56-week period.
CONDITIONS
Brief Title
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 5 to less than 18 years at the time of randomization
- Confirmed diagnosis of juvenile psoriatic arthritis (JPsA) of at least 6 months duration according to ILAR Edmonton Revision criteria
- Arthritis with psoriasis, or arthritis plus at least two of the following: dactylitis, nail pitting or onycholysis, psoriasis in a first-degree relative
- Active disease with at least 3 active joints
- Inadequate response or intolerance to at least one disease-modifying anti-rheumatic drug (DMARD) for at least 2 months
You will not qualify if you...
- Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
- History or presence of ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or similar disorders in a first-degree relative
- History of IgM rheumatoid factor positivity on at least 2 occasions at least 3 months apart
- Presence of systemic juvenile idiopathic arthritis (JIA)
- Rheumatic autoimmune diseases other than psoriatic arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia
- Prior or current inflammatory joint diseases other than psoriatic arthritis, such as gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, or Lyme disease
Research Team
A
Amgen Call Center
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