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)
Who is this study for? Children from 5 to less than 18 years of age with active juvenile psoriatic arthritis
What treatments are being studied? Apremilast
Status: Recruiting
Location: See all (42) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Austria
Landeskrankenhaus Bregenz
RECRUITING
Bregenz
Belgium
Universitair Ziekenhuis Gent
TERMINATED
Ghent
Centre Hospitalier Regional de la Citadelle
TERMINATED
Liège
Ziekenhuis Netwerk Antwerpen Jan Palfijn
TERMINATED
Merksem
France
Hospices Civils de Lyon Hopital Femme Mere Enfant
RECRUITING
Bron
Hopital Jeanne de Flandre
RECRUITING
Lille
Germany
Charite - Universitaetsmedizin Berlin, Campus Virchow
RECRUITING
Berlin
Universitaetsklinikum Dresden
RECRUITING
Dresden
An der Schoen Klinik Hamburg Eilbek
RECRUITING
Hamburg
Asklepios Kinderklinik Sankt Augustin GmbH
COMPLETED
Sankt Augustin
Greece
Agia Sofia Children Hospital
RECRUITING
Athens
Attikon University General Hospital
RECRUITING
Athens
General Hospital of Thessaloniki Ippokrateio
RECRUITING
Thessaloniki
Italy
Ospedale Santissima Annunziata
RECRUITING
Chieti
IRCCS Istituto Giannina Gaslini
RECRUITING
Genova
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
RECRUITING
Milan
IRCCS Ospedale Pediatrico Bambino Gesu
RECRUITING
Roma
Lithuania
Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
RECRUITING
Vilnius
Netherlands
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
RECRUITING
Krakow
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
RECRUITING
Lodz
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
RECRUITING
Warsaw
Portugal
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
RECRUITING
Lisbon
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
TERMINATED
Porto
Romania
Spitalul Clinic de Urgenta pentru Copii Cluj
RECRUITING
Cluj-napoca
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
RECRUITING
Timișoara
South Africa
Groote Schuur Hospital
TERMINATED
Cape Town
Panorama Medical Centre
RECRUITING
Panorama
Spain
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Sant Joan de Deu
RECRUITING
Esplugues De Llorbregat
Hospital Universitario La Paz
TERMINATED
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi
RECRUITING
Ankara
Istanbul Universitesi Cerrahpasa Tip Fakultesi
RECRUITING
Istanbul
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
RECRUITING
Istanbul
Umraniye Egitim ve Arastirma Hastanesi
RECRUITING
Istanbul
United Kingdom
Birmingham Childrens Hospital
RECRUITING
Birmingham
Alder Hey Childrens Hospital
TERMINATED
Liverpool
Nottingham Childrens Hospital
RECRUITING
Nottingham
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2022-03-17
Estimated Completion Date: 2028-12-29
Participants
Target number of participants: 60
Treatments
Experimental: Apremilast
Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.
Placebo_comparator: Placebo to Apremilast
Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.
Related Therapeutic Areas
Sponsors
Leads: Amgen