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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 January 2021
Main ID:  NCT04528082
Date of registration: 24/08/2020
Prospective Registration: Yes
Primary sponsor: Amgen
Public title: Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease BEAN
Scientific title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)
Date of first enrolment: July 15, 2021
Target sample size: 60
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04528082
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Contacts
Name:     Amgen Call Center
Address: 
Telephone: 866-572-6436
Email: medinfo@amgen.com
Affiliation: 
Name:     MD
Address: 
Telephone:
Email:
Affiliation:  Amgen
Key inclusion & exclusion 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.

- 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).



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All
Health Condition(s) or Problem(s) studied
Behçet Disease
Intervention(s)
Drug: Apremilast
Drug: Placebo
Primary Outcome(s)
Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12) [Time Frame: Week 0 to Week 12]
Secondary Outcome(s)
Change from Week 0 to Week 12 in Disease Activity [Time Frame: Week 0 to Week 12]
Change from Week 0 to Week 12 in the Pain of Oral Ulcers [Time Frame: Week 0 to Week 12]
Change from Week 0 to Week 12 of the 10-item Short Form Survey (SF-10) [Time Frame: Week 0 to Week 12]
Change from Week 0 to Week 52 in Body Mass Index (BMI) [Time Frame: Week 0 to Week 52]
Change from Week 0 to Week 52 in Body Weight [Time Frame: Week 0 to Week 52]
Change from Week 0 to Week 52 in Height [Time Frame: Week 0 to Week 52]
Change from Week 0 to Week 52 in Tanner Staging [Time Frame: Week 0 to Week 52]
Complete Response Rate for Genital Ulcers [Time Frame: Week 12]
Complete Response Rate for Oral Ulcers [Time Frame: Week 12]
Number of Oral Ulcers from Week 0 to Week 12 [Time Frame: Week 0 to Week 12]
Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) = Grade 3 Adverse Events [Time Frame: Up to Week 56]
Number of Participants Reporting One or More Treatment-related Adverse Events [Time Frame: Up to Week 56]
Number of Participants who Experience a Clinically Significant Change from Week 0 in Clinical Laboratory Tests [Time Frame: Week 0 to Week 56]
Number of Participants who Experience a Clinically Significant Change from Week 0 in Physical Examinations [Time Frame: Week 0 to Week 56]
Number of Participants who Experience a Clinically Significant Change from Week 0 in Vital Signs [Time Frame: Week 0 to Week 56]
Number of Participants who Experience One or More Serious Adverse Events (SAEs) [Time Frame: Up to Week 56]
Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to Week 56]
Number of Participants Who Have New-onset or Recurrence of Behçet's-related Manifestations (Other than Oral and Genital Ulcers) [Time Frame: Week 12]
Number of Participants who Require Protocol-prohibited Medications due to Worsening of Behçet's Disease [Time Frame: Week 0 to Week 12]
Number of Participants whose Number of Oral Ulcers is Reduced by = 50% from Week 0 [Time Frame: Week 0 to Week 12]
Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS) [Time Frame: Up to Week 56]
Plasma Concentrations of Apremilast [Time Frame: Up to Week 52]
Taste and Acceptability [Time Frame: Week 0 and Week 2]
Secondary ID(s)
2019-002787-27
20190530
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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