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Looking for participantsPhase3

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Sponsor: Amgen

NCT ID: NCT04804553

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Apremilast (drug), Placebo (drug)
How long the study runs
Study runs about 81 months (dates as stated)
About the drug or intervention
Apremilast — drug: Participants will receive apremilast orally. · Placebo — drug: Participants will receive the matching placebo orally.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
5 Years to 17 Years
Who
All
Number of participants
60
Started
2022-03-17
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for active juvenile psoriatic arthritis
  • • Phase3 - 60 participants
  • • 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

Who can take part?

  • • Ages 5 Years to 17 Years
  • • Diagnosed with active juvenile psoriatic arthritis

Where?

  • • Birmingham - Birmingham Childrens Hospital
  • • Liverpool - Alder Hey Childrens Hospital
  • • Nottingham - Nottingham Childrens Hospital
  • • Oxford - John Radcliffe Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Active Juvenile Psoriatic Arthritis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 5 Years - 17 Years
  • Who can join: All genders

Biomarkers mentioned

PsA

What the study is looking for

  • ✓Male or Female participants 5 to \< 18 years of age at the time of randomization.
  • ✓Arthritis and psoriasis, OR
  • ✓Arthritis with at least 2 of the following:
  • ✓Dactylitis
  • ✓Nail pitting or onycholysis

Who cannot take part

  • ✗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...
  • ✗History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
  • ✗Presence of systemic juvenile idiopathic arthritis (JIA).
See the full 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 Is This Study? (4 UK sites)

Birmingham Childrens Hospital

Birmingham B4 6NH, United Kingdom

TERMINATED
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Alder Hey Childrens Hospital

Liverpool L12 2AP, United Kingdom

TERMINATED
Hospital R&D contact (matched)

Kelly Davies

research@alderhey.nhs.uk0151 2525570

Nottingham Childrens Hospital

Nottingham NG7 2UH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

John Radcliffe Hospital

Oxford OX3 7LD, United Kingdom

Recruiting

How to Get in Touch

Amgen Call Center

Sponsor contact

CONTACT

866-572-6436 medinfo@amgen.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09