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Clinical Trials in the UK / NCT04528082
Recruiting Phase 3

Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease

NCT04528082 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2021-09-09
Last updated
2026-07-24

Condition(s) studied

Behçet Disease

Investigational drug(s) / intervention(s)

ApremilastPlacebo

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

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Key Inclusion Criteria * 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. Key Exclusion Criteria * Behçet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), or CNS (eg, meningoencephalitis) manifestations, or ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however: * Previous major organ involvement is allowed if it occurred ≥1 year prior to the screening visit and is not active at time of enrollment * Participants with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed * Participants with BD-related arthritis and BD-skin manifestations are also allowed. * Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of BD).

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
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 the UK

Official registry record

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 the UK