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New treatment option for Behçet Disease
Official title Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
ClinicalTrials.gov ID: NCT04528082
What this study is testing
What is Apremilast?
Apremilast is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for behçet disease.
Also referred to as Otezla®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Key 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
You likely can't join if
- Behçet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis)...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
- Paris, France
- 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
- Lausanne, Switzerland
- Ankara, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)
- Izmir, Turkey (Türkiye)
- Kayseri, Turkey (Türkiye)
- Birmingham, United Kingdom
+ 2 more site(s).
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, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France; Paris, France; Athens, Greece; Thessaloniki, Greece; Kfar Saba, Israel; Chieti, Italy and 16 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.