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

NCT04528082

RecruitingPhase 3

Sponsor: Amgen

Conditions: Behçet Disease

Interventions: Apremilast, Placebo

Countries: France, Greece, Israel, Italy, Spain, Switzerland, Turkey (Türkiye), United Kingdom

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 overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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).
Locations (27)
  • Bron, France
  • Paris, France
  • Paris, France
  • Athens, Greece
  • Athens, Greece
  • Thessaloniki, Greece
  • Kfar Saba, Israel
  • Chieti, Italy
  • Genova, Italy
  • Milan, Italy
  • Roma, Italy
  • Seville, Andalusia, Spain
  • Barcelona, Catalonia, Spain
  • Esplugues de Llobregat, Catalonia, Spain
  • Valencia, Valencia, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Lausanne, Switzerland
  • Ankara, Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)
  • Kayseri, Turkey (Türkiye)
  • Birmingham, United Kingdom
  • Liverpool, United Kingdom
  • Oxford, United Kingdom