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)
- Conditions
- Behçets syndromeSilk Road Disease1000381610047066
- Registration Number
- NL-OMON54968
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 4
Main inclusion criteria:
- Male or Female participants 2 to < 18 years of age at randomization
- Subject must have a weight of * 12 kg at randomization
- Diagnosed with Behçet's disease meeting the International Study Group for
Behçet*s 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
- Subject must have * 2 oral ulcers at both the screening visit and on day 1
- Subject has had prior treatment with * 1 non-biologic Behçet`s disease
therapy, such as, but not limited to, topical corticosteroids or systemic
treatment
- Subject is a candidate for systemic therapy for the treatment of oral
ulcers. A candidate for systemic therapy is a subject judged by the study
Investigator as
someone whose oral ulcers are considered inappropriate for topical therapy
based on the severity of disease and extent of the affected area, or whose oral
ulcers cannot be adequately controlled by topical therapy as judged by the
Investigator.
Inclusion criteria are described in more detail in section 5.1 of the protocol.
Main 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), and central nervous system (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
* Subjects with mild BD-related ocular lesions not requiring systemic
immunosuppressive therapy are allowed
* Subjects 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)
- Receipt of concomitant immune modulating therapy (except oral or topical
corticosteroids, which must have been tapered during screening as appropriate
and discontinued prior to randomization) within specified time based on type of
drug.
- History or evidence of any other clinically significant disorder, condition
or disease that could pose a risk to subject safety or interfere with the study
evaluation, procedures or completion.
- Female subject who is (or plans to become) pregnant or breastfeeding.
- Female subject of child bearing potential unwilling to use 1 highly effective
method of contraception.
Exclusion criteria are described in more detail in section 5.2 of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of the study is to assess the area under the curve for the<br /><br>number of oral ulcers from Week 0 through Week 12 (AUC W0-W12).</p><br>
- Secondary Outcome Measures
Name Time Method