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)
Who is this study for? Patients with Behcet Syndrome
What treatments are being studied? Apremilast
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• Male or Female participants 2 to \< 18 years of age at randomization.
• Diagnosed with BD meeting the ISGBD criteria at any time prior to the screening visit.
• Oral ulcers that occurred ≥ 3 times within the 12-month period prior to the screening visit.
• Participant must have ≥ 2 oral ulcers at both the screening visit and on day 1.
• Participant has had prior treatment with ≥ 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids or systemic treatment.
Locations
Other Locations
France
Hospices Civils de Lyon Hopital Femme Mere Enfant
RECRUITING
Bron
Hopital Necker Enfants Malades
TERMINATED
Paris
Hopital Robert Debre
RECRUITING
Paris
Greece
Agia Sofia Children Hospital
RECRUITING
Athens
Attikon University General Hospital
RECRUITING
Athens
General Hospital of Thessaloniki Ippokrateio
RECRUITING
Thessaloniki
Israel
Meir Medical Center
RECRUITING
Kfar Saba
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
Spain
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Sant Joan de Deu
RECRUITING
Esplugues De Llobregat
Hospital Universitario La Paz
TERMINATED
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Switzerland
Centre Hospitalier Universitaire Vaudois
TERMINATED
Lausanne
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
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
RECRUITING
Izmir
Erciyes Universitesi Tip Fakultesi Hastanesi
RECRUITING
Kayseri
United Kingdom
Birmingham Childrens Hospital
RECRUITING
Birmingham
Alder Hey Childrens Hospital
RECRUITING
Liverpool
John Radcliffe Hospital
RECRUITING
Oxford
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2021-09-09
Estimated Completion Date: 2030-12-17
Participants
Target number of participants: 60
Treatments
Experimental: Apremilast
Participants will receive apremilast orally in the double-blind 12 week treatment phase. Then the participants will continue to receive apremilast in the active 40 weeks treatment phase.
Placebo_comparator: Placebo to Apremilast
Participants will receive the matching placebo orally in the double-blind 12 week treatment phase. Then the participants will receive apremilast in the active 40 weeks treatment phase.
Related Therapeutic Areas
Sponsors
Leads: Amgen