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Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

NCT ID: NCT04804553
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Amgen
Conditions: Active Juvenile Psoriatic Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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)

Enrollment: 60 participants (Estimated).

What is being studied

Intervention: apremilast
Drug: Apremilast
Drug: Placebo

Who may be eligible

Ages: 5 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility 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).

Study locations

44 study locations are listed.

Recruiting site status is explicitly provided for 44 locations; 23 are listed as Recruiting.

Countries: Belgium, France, Germany, Greece, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, South Africa, Spain, Turkey (Türkiye), United Kingdom

Western Cape, South Africa: 1
Canary Islands, Spain: 1
Catalonia, Spain: 2
Valencia, Spain: 1

Sample of listed locations

Hospices Civils de Lyon Hopital Femme Mere Enfant — Bron, 69677, France — Recruiting
Hopital Jeanne de Flandre — Lille, 59037, France — Recruiting
Charite - Universitaetsmedizin Berlin, Campus Virchow — Berlin, 13353, Germany — Recruiting
General Hospital of Thessaloniki Ippokrateio — Thessaloniki, 54642, Greece — Recruiting
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini — Milan, 20122, Italy — Recruiting
Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine — Vilnius, 08406, Lithuania — Recruiting
Universitair Medisch Centrum Utrecht — Utrecht, 3584 EA, Netherlands — Recruiting
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria — Lisbon, 1649-035, Portugal — Recruiting
Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos — Ponte de Lima, 4990-041, Portugal — Recruiting
Unidade Local de Saude de Gaia-Espinho, EPE — Vila Nova de Gaia, 4430-502, Portugal — Recruiting
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara — Timișoara, 300011, Romania — Recruiting
Panorama Medical Centre — Panorama, Western Cape, 7500, South Africa — Recruiting
Hospital Universitario de Canarias — San Cristóbal de La Laguna, Canary Islands, 38320, Spain — Recruiting
Hospital Universitari Vall d Hebron — Barcelona, Catalonia, 08035, Spain — Recruiting
Hospital Sant Joan de Deu — Esplugues de Llobregat, Catalonia, 08950, Spain — Recruiting
Hospital Universitari i Politecnic La Fe — Valencia, Valencia, 46026, Spain — Recruiting
Hospital Universitario Ramon y Cajal — Madrid, 28034, Spain — Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara, 06100, Turkey (Türkiye) — Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi — Istanbul, 34098, Turkey (Türkiye) — Recruiting
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi — Istanbul, 34093, Turkey (Türkiye) — Recruiting
Umraniye Egitim ve Arastirma Hastanesi — Istanbul, 34764, Turkey (Türkiye) — Recruiting
Nottingham Childrens Hospital — Nottingham, NG7 2UH, United Kingdom — Recruiting
John Radcliffe Hospital — Oxford, OX3 7LD, United Kingdom — Recruiting
Universitair Ziekenhuis Gent — Ghent, 9000, Belgium — Terminated
Centre Hospitalier Regional de la Citadelle — Liège, 4000, Belgium — Terminated

Study details

Start date: March 17, 2022
Primary completion date: March 21, 2028
Completion date: December 29, 2028
First posted: March 18, 2021

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT04804553
Registry last updated: October 5, 2026
QualifiedStudies registry data refreshed: October 12, 2026
QualifiedStudies record fetched: October 12, 2026

View NCT04804553 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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