Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
NCT ID: NCT04528082
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2021-09-09
2030-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Participants who complete the 52 weeks of treatment may have the opportunity to continue receiving apremilast through an open-label extension study (NCT05767047) . The participants who choose not to participate in the optional open-label, long-term study will complete the 30 days safety follow-up period after the last dose of apremilast in the active treatment phase.
TREATMENT
QUADRUPLE
Study Groups
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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.
Apremilast
Participants will receive apremilast orally.
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.
Apremilast
Participants will receive apremilast orally.
Placebo
Participants will receive the matching placebo orally.
Interventions
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Apremilast
Participants will receive apremilast orally.
Placebo
Participants will receive the matching placebo orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
2 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, , France
Hopital Necker Enfants Malades
Paris, , France
Hopital Robert Debre
Paris, , France
Agia Sofia Children Hospital
Athens, , Greece
Attikon University General Hospital
Athens, , Greece
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, , Greece
Meir Medical Center
Kfar Saba, , Israel
Ospedale Santissima Annunziata
Chieti, , Italy
IRCCS Istituto Giannina Gaslini
Genova, , Italy
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
Milan, , Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, , Italy
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
Izmir, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, , Turkey (Türkiye)
Birmingham Childrens Hospital
Birmingham, , United Kingdom
Alder Hey Childrens Hospital
Liverpool, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-503436-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
20190530
Identifier Type: -
Identifier Source: org_study_id
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