Actively Recruiting
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Led by Amgen · Updated on 2025-12-01
60
Participants Needed
27
Research Sites
483 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 2 to less than 18 years old at randomization
- Diagnosed with Behet's disease meeting ISGBD criteria before screening
- Oral ulcers occurred 3 or more times in the 12 months before screening
- Participant has 2 or more oral ulcers at screening and on day 1
- Previous treatment with at least one non-biologic Behet's disease therapy (e.g., topical corticosteroids or systemic treatment)
You will not qualify if you...
- Active major organ involvement related to Behet's disease requiring immunosuppressive therapy, including pulmonary, vascular, gastrointestinal, central nervous system, or ocular lesions
- Major organ involvement allowed if it occurred 1 year or more before screening and is inactive
- Mild ocular lesions not requiring systemic immunosuppressive therapy are allowed
- Behet's disease-related arthritis and skin manifestations are allowed
- Previous use of biologic therapies for Behet's disease oral ulcers is not allowed, but biologic use for other conditions is allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, France, 69677
Actively Recruiting
2
Hopital Necker Enfants Malades
Paris, France, 75015
Terminated
3
Hopital Robert Debre
Paris, France, 75019
Actively Recruiting
4
Agia Sofia Children Hospital
Athens, Greece, 11527
Actively Recruiting
5
Attikon University General Hospital
Athens, Greece, 12462
Actively Recruiting
6
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, Greece, 54642
Actively Recruiting
7
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
8
Ospedale Santissima Annunziata
Chieti, Italy, 66100
Actively Recruiting
9
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16147
Actively Recruiting
10
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
Milan, Italy, 20122
Actively Recruiting
11
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy, 00165
Actively Recruiting
12
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain, 41013
Actively Recruiting
13
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
14
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain, 08950
Actively Recruiting
15
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
16
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
17
Hospital Universitario La Paz
Madrid, Spain, 28046
Terminated
18
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Terminated
19
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
20
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
21
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
22
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, Turkey (Türkiye), 34764
Actively Recruiting
23
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey (Türkiye), 35330
Terminated
24
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, Turkey (Türkiye), 38030
Actively Recruiting
25
Birmingham Childrens Hospital
Birmingham, United Kingdom, B4 6NH
Terminated
26
Alder Hey Childrens Hospital
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
27
John Radcliffe Hospital
Oxford, United Kingdom, OX3 7LD
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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