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Apremilast study in children with active oral ulcers associated with Behçet's Disease
EU CTIS ID: 2023-503436-40-00
What this study is testing
To estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric subjects from 2 to less than 18 years of age with oral ulcers associated with Behçet's Disease (BD) through week 12.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or Female subjects 2 to less than 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 more or equal to 3 times within the 12-month period prior to the screening visit.
- Subject must have more or equal to 2 oral ulcers at both the screening visit and on day 1.
- Subject has had prior treatment with more or equal to 1 non-biologic BD 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.
You likely can't join if
- 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, eningoencephalitis) 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; -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).
- History or evidence of any other clinically significant disorder, condition or disease that would 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 childbearing potential unwilling to use 1 highly effective method of contraception.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Israel
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Israel; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.