Ustekinumab for Intestinal Behçet's Syndrome With Myelodysplastic Syndrome (NCT07582991) | Clinical Trial Compass
CompletedPhase 2
Ustekinumab for Intestinal Behçet's Syndrome With Myelodysplastic Syndrome
China8 participantsStarted 2024-03-24
Plain-language summary
Behçet's syndrome is a systemic vasculitis. Gastrointestinal involvement in Behçet's syndrome complicated by myelodysplastic syndrome represents a rare and severe subtype for which no standardized treatment guidelines currently exist, posing significant challenges in clinical practice. Ustekinumab, a biologic agent targeting IL-12/IL-23, has demonstrated favorable efficacy in both gastrointestinal Behçet's syndrome and inflammatory bowel disease. This study aims to evaluate the efficacy and safety of ustekinumab in patients with intestinal Behçet's syndrome and coexisting myelodysplastic syndrome.
Who can participate
Age range
18 Years – 70 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:
Meet the 2014 International Criteria for Behçet's Disease (ICBD) for the diagnosis of Behçet's syndrome; Have a confirmed diagnosis of myelodysplastic syndrome (MDS) by bone marrow aspiration and/or biopsy; Have confirmed intestinal ulcers on colonoscopy; Aged between 18 and 70 years; Have active disease at enrollment, defined as a Behçet's Disease Current Activity Form (BDCAF) score ≥ 1; Provide signed informed consent.
Exclusion Criteria:
Presence of one or more other autoimmune diseases; Involvement of other vital organs (e.g., cardiovascular, neurological) requiring treatment with other biologic agents or high-dose corticosteroids; Receipt of surgical treatment; Severe trilineage cytopenia attributed to myelodysplastic syndrome; Presence of acute or chronic active infection (e.g., bacterial, or viral infections such as EBV, CMV, HIV, or active hepatitis virus) within 4 weeks prior to enrollment; Current or prior history of any malignancy; Pregnancy or within 6 months postpartum; Presence of severe liver failure (Child-Pugh Class C) or end-stage renal disease requiring dialysis.
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.
1Since this trial is already completed, has the results data been published yet, and would you be able to walk me through what the findings showed about complete remission, marked improvement, and improvement rates for patients with both intestinal Behçet's syndrome and myelodysplastic syndrome?
2Because this trial specifically enrolled patients with both intestinal Behçet's syndrome AND myelodysplastic syndrome together, does my particular combination and severity of both conditions match the kind of patients who were studied here?
3Ustekinumab targets the immune system — given that myelodysplastic syndrome already affects the bone marrow and blood cells, what does my care team think about the safety profile of using an immune-modulating drug like ustekinumab in someone with my situation?
4Are there currently approved or standard treatments for intestinal Behçet's syndrome with MDS that I should consider first, or does the evidence from this Phase 2 trial suggest ustekinumab might be worth pursuing as a real option for me?
5Since this was a Phase 2 trial, what does that mean about how much we still don't know regarding long-term safety and effectiveness of ustekinumab for this condition, and are there any follow-up or Phase 3 studies I should ask about?
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
Patients achieving complete remission, marked improvement, and improvement