Recruiting
Sponsor ID
20190530
Apremilast Pediatric Study in Children with Active Oral Ulcers Associated with Behçet’s DiseaseBEAN
Study Details
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.
Protocol Summary
Primary Outcome Measures
Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12)
Timeframe: Week 0 to Week 12
Secondary Outcome Measures
Number of Oral Ulcers from Week 0 to Week 12
Timeframe: Week 0 to Week 12
Change from Week 0 to Week 12 in the Pain of Oral Ulcers in Participants 5 Years of Age and Older
Timeframe: Week 0 to Week 12
Complete Response Rate for Oral Ulcers
Timeframe: Week 12
Proportion of Participants at Week 12 Whose Number of Oral Ulcers is Reduced by Greater Than or Equal to 50% from Week 0
Timeframe: Week 0 to Week 12
Complete Response Rate for Genital Ulcers
Timeframe: Week 12
Change from Week 0 to Week 12 in Disease Activity
Timeframe: Week 0 to Week 12
Proportion of Participants at Week 12 Who Have New-onset or Recurrence of Behçet’s-related Manifestations (Other than Oral and Genital Ulcers)
Timeframe: Week 12
Change from Week 0 to Week 12 on the Short Form Survey (SF-10)
Timeframe: Week 0 to Week 12
Number of Participants with a Treatment-emergent Adverse Event
Timeframe: Up to Week 56
Occurrence, Severity, and Frequency of Suicide/Suicide-related Ideations and Behaviors as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Timeframe: Up to Week 56
Change from Week 0 to Week 52 in Tanner Staging
Timeframe: Week 0 to Week 52
Change in Body Weight Measurements
Timeframe: Week 0 to Week 56
Change in Height Measurements
Timeframe: Week 0 to Week 56
Change in Body Mass Index (BMI)
Timeframe: Week 0 to Week 56
Plasma Concentrations of Apremilast
Timeframe: Up to Week 52
Taste and Acceptability of Apremilast
Timeframe: Week 0 and Week 2
Proportion of Participants Who Require Protocol-prohibited Medications due to Worsening of Behçet’s Disease
Timeframe: Week 0 to Week 12
Locations
Location
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain, 28034
Status
Recruiting
Location
Hospital Sant Joan de Deu
Esplugues de Llobregat, Cataluña, Spain, 08950
Status
Recruiting
Location
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16147
Status
Recruiting
Location
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Status
Terminated
Location
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Status
Terminated
Location
Hospital Universitario Virgen del Rocio
Sevilla, Andalucía, Spain, 41013
Status
Recruiting
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