Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Apremilast: Participants will receive apremilast orally.
Placebo: Participants will receive the matching placebo orally.
Study 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
Primary outcome measure(s)
- Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12) — Week 0 to Week 12
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospices Civils de Lyon Hopital Femme Mere Enfant | Bron | France | Recruiting |
| Hopital Necker Enfants Malades | Paris | France | Terminated |
| Hopital Robert Debre | Paris | France | Recruiting |
| Agia Sofia Children Hospital | Athens | Greece | Recruiting |
| Attikon University General Hospital | Athens | Greece | Recruiting |
| General Hospital of Thessaloniki Ippokrateio | Thessaloniki | Greece | Recruiting |
| Meir Medical Center | Kfar Saba | Israel | Recruiting |
| Ospedale Santissima Annunziata | Chieti | Italy | Terminated |
| IRCCS Istituto Giannina Gaslini | Genova | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini | Milan | Italy | Terminated |
| IRCCS Ospedale Pediatrico Bambino Gesu | Roma | Italy | Recruiting |
| Hospital Universitario Virgen del Rocio | Seville | Andalusia | Recruiting |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | Recruiting |
| Hospital Sant Joan de Deu | Esplugues de Llobregat | Catalonia | Recruiting |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Terminated |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | Terminated |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi | Istanbul | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul | Turkey (Türkiye) | Recruiting |
| Umraniye Egitim ve Arastirma Hastanesi | Istanbul | Turkey (Türkiye) | Recruiting |
| Dokuz Eylul Universitesi Tip Fakultesi Hastanesi | Izmir | Turkey (Türkiye) | Terminated |
| Erciyes Universitesi Tip Fakultesi Hastanesi | Kayseri | Turkey (Türkiye) | Recruiting |
| Birmingham Childrens Hospital | Birmingham | United Kingdom | Terminated |
| Alder Hey Childrens Hospital | Liverpool | United Kingdom | Recruiting |
| John Radcliffe Hospital | Oxford | United Kingdom | Recruiting |
On this site
📄 Otezla (apremilast) drug profile →More Amgen trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04528082 on ClinicalTrials.gov ↗ ← All trials in Spain