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Treatment of active juvenile psoriatic arthritis in children using apremilast

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)

Phase 3 Interventional Amgen · NCT04804553

This study is testing if a medication called apremilast can help children with active juvenile psoriatic arthritis feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment60 (estimated)
Ages5 Years to 17 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsmethotrexate
Locations45 sites (Bregenz and 44 other locations)
Trial IDNCT04804553 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy of apremilast, a medication used to treat inflammatory disorders, compared to a placebo in children aged 5 to less than 18 years with active juvenile psoriatic arthritis (JPsA). Participants must have a confirmed diagnosis of JPsA and show inadequate response or intolerance to previous treatments. The study will involve randomization to receive either apremilast or a placebo over a specified period to assess improvements in their condition.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 5 to less than 18 years with a confirmed diagnosis of active juvenile psoriatic arthritis.

Not a fit: Patients with arthritis due to HLA-B27 positivity or those with ankylosing spondylitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for children suffering from juvenile psoriatic arthritis, potentially improving their quality of life.

How similar studies have performed: Other studies have shown success with similar approaches in treating juvenile psoriatic arthritis, indicating a potential for positive outcomes.

Eligibility criteria

Show full inclusion / exclusion 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.
* 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).

Where this trial is running

Bregenz and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Active Juvenile Psoriatic ArthritisApremilastOtezla®Juvenile psoriatic arthritisInflammatory disorders
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.