Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients Wit… (NCT02648581) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease
France16 participantsStarted 2017-06-14
Plain-language summary
The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients with active posterior uveitis or panuveitis (STELABEC-2)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Are at least 18 years of age.
. Have a diagnosis of BD according to the International Classification Criteria (criteria from the International Study Group and/or the 2013 International Criteria for BD).
. Have an active disease at screening, defined by the presence of :
. Have previously received at least 1 non-biologic therapy :
. Are without treatment regimen (due to ineffectiveness / intolerance) or on a stable BC treatment regimen consisting of any of the following medications (alone or in combination) : Corticosteroids for a period of at least 2 weeks prior to Day 0 Colchicine for a period of at least 30 days prior to Day 0 Immunosuppressive or immunomodulatory agents for a period of at least 30 days prior to Day 0 Thalidomide for a period of at least 60 days prior to Day 0
. A female subject is eligible to enter the study if she is :
. Have the ability to understand the requirements of the study provide written informed consent (including consent for the use and disclosure of research-related health information) and comply with the study protocol procedures (including required study visits).
. Affiliation with a mode of social security (profit or being entitled)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested ustekinumab specifically for Behçet disease symptoms like oral ulcers and uveitis — since it's a Phase 2 study that's now completed, what does my doctor think the results suggest about whether this drug actually worked for those problems, and is the evidence strong enough yet to consider it as a real treatment option for me?
2The trial measured outcomes at week 24, which means patients were on this treatment for at least several months — given that ustekinumab blocks IL-12 and IL-23, which affect the immune system, what safety concerns did my doctor notice in this study that I should weigh against any potential benefit?
3Since this trial focused on two very specific Behçet disease complications — oral ulcers and uveitis or retinal vasculitis — would it matter which of those problems is most affecting me when deciding whether this approach might be worth discussing further?
4Because this was a Phase 2 trial, it was designed mainly to get early signals on whether this drug works and is safe, rather than to give definitive proof — are there larger or more advanced trials my doctor is aware of, or is there an already-approved treatment I should try first before considering something still in earlier-stage research?
5Ustekinumab is given as an injection and requires ongoing monitoring — if my doctor thinks this is worth exploring, what would the practical demands actually look like in terms of how often I'd need to come in, and how does that compare to other Behçet disease treatments I might already be eligible for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of oral ulcers at week 24 compared to baseline