Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease (BEAN)
Behçet Disease
About this trial
This is an interventional treatment trial for Behçet Disease focused on measuring Behçet's Disease, Oral ulcers, Apremilast
Eligibility Criteria
Key Inclusion Criteria
- Male or Female participants 2 to < 18 years of age at randomization.
- Diagnosed with behçet's disease (BD) meeting the International Study Group for Behçet Disease (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
Behcet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), and central nervous system (CNS) (eg, meningoencephalitis) manifestations, and 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).
Sites / Locations
- Hospices Civils de Lyon Hopital Femme Mere EnfantRecruiting
- Hopital Necker Enfants MaladesRecruiting
- Hopital Robert DebreRecruiting
- Agia Sofia Children HospitalRecruiting
- Attikon University General HospitalRecruiting
- General Hospital of Thessaloniki IppokrateioRecruiting
- Meir Medical CenterRecruiting
- Ospedale Santissima AnnunziataRecruiting
- IRCCS Istituto Giannina GasliniRecruiting
- Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano PiniRecruiting
- IRCCS Ospedale Pediatrico Bambino GesuRecruiting
- Hospital Universitario Virgen del RocioRecruiting
- Hospital Universitari Vall d HebronRecruiting
- Hospital Sant Joan de DeuRecruiting
- Hospital Universitari i Politecnic La FeRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Universitario La PazRecruiting
- Centre Hospitalier Universitaire Vaudois
- Hacettepe Universitesi Tip FakultesiRecruiting
- Istanbul Universitesi Istanbul Tip FakultesiRecruiting
- Umraniye Egitim ve Arastirma HastanesiRecruiting
- Dokuz Eylul Tip Fakultesi Arastirma Uygulama HastanesiRecruiting
- Erciyes Universitesi Tip FakultesiRecruiting
- Birmingham Childrens HospitalRecruiting
- Alder Hey Childrens HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Apremilast
Placebo to 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.
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.