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Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Sponsor: Amgen
Summary
The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to \< 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.
Official title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2021-09-09
Completion Date
2030-12-17
Last Updated
2025-12-01
Healthy Volunteers
No
Conditions
Interventions
Apremilast
Participants will receive apremilast orally.
Placebo
Participants will receive the matching placebo orally.
Locations (27)
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, France
Hopital Necker Enfants Malades
Paris, France
Hopital Robert Debre
Paris, France
Agia Sofia Children Hospital
Athens, Greece
Attikon University General Hospital
Athens, Greece
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, Greece
Meir Medical Center
Kfar Saba, Israel
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
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 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
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
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)
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, Turkey (Türkiye)
Birmingham Childrens Hospital
Birmingham, United Kingdom
Alder Hey Childrens Hospital
Liverpool, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom