RecruitingPhase 3NCT04804553

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

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)

Sponsor

Amgen

Enrollment

60 participants

Start Date

Mar 17, 2022

Study Type

INTERVENTIONAL

Conditions

Active Juvenile Psoriatic Arthritis

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.

Eligibility

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Apremilast and a drug called Placebo for people with active juvenile psoriatic arthritis. The study is currently recruiting participants at 45 locations. People eligible for this study include aged 5 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApremilast

Participants will receive apremilast orally.

DRUGPlacebo

Participants will receive the matching placebo orally.

Locations(45)

Landeskrankenhaus Bregenz

Bregenz, Austria

Universitair Ziekenhuis Gent

Ghent, Belgium

Centre Hospitalier Regional de la Citadelle

Liège, Belgium

Ziekenhuis Netwerk Antwerpen Jan Palfijn

Merksem, Belgium

Hospices Civils de Lyon Hopital Femme Mere Enfant

Bron, France

Hopital Jeanne de Flandre

Lille, France

Charite - Universitaetsmedizin Berlin, Campus Virchow

Berlin, Germany

Universitaetsklinikum Dresden

Dresden, Germany

An der Schoen Klinik Hamburg Eilbek

Hamburg, Germany

Asklepios Kinderklinik Sankt Augustin GmbH

Sankt Augustin, Germany

Agia Sofia Children Hospital

Athens, Greece

Attikon University General Hospital

Athens, Greece

General Hospital of Thessaloniki Ippokrateio

Thessaloniki, Greece

Ospedale Santissima Annunziata

Chieti, Italy

IRCCS Istituto Giannina Gaslini

Genova, Italy

Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini

Milan, Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, Italy

Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine

Vilnius, Lithuania

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie

Krakow, Poland

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, Poland

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

Warsaw, Poland

Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, Portugal

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, Portugal

Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos

Ponte de Lima, Portugal

Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

Porto, Portugal

Unidade Local de Saude de Gaia-Espinho, EPE

Vila Nova de Gaia, Portugal

Spitalul Clinic de Urgenta pentru Copii Cluj

Cluj-Napoca, Romania

Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

Timișoara, Romania

Panorama Medical Centre

Panorama, Western Cape, South Africa

Groote Schuur Hospital

Cape Town, South Africa

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Canary Islands, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital Sant Joan de Deu

Esplugues de Llobregat, Catalonia, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey (Türkiye)

Umraniye Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Birmingham Childrens Hospital

Birmingham, United Kingdom

Alder Hey Childrens Hospital

Liverpool, United Kingdom

Nottingham Childrens Hospital

Nottingham, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04804553