The study aims to explore the clinical and immunological efficacy of low-dose IL-2 on Behcet's Disease.
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
. Male or female 18-70 years of age at time of screening.
. Diagnosis of Behçet's Disease (according to the 1989 ICBD) for ≥3 months before screening.
. Active oral ulcer at time of screening.
. Patients on corticosteroids (≤1 mg/kg/d prednisone or equivalent), DMARDs (e.g. methotrexate, hydroxychloroquine, azathioprine, MMF, leflunomide, ciclosporin etc.), must have been on a stable dose for 4 weeks prior to receiving the first infusion of study medication and expected to remain on this dose throughout the study. If the registered doctor plans to quit using current DMARDs or glucocorticoids, the washout period needs to be followed before patients join the groups. Each drug needs to meet the following washout period
. Given their written informed consent to participate in the trial and expected to be able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
. BD-related active major organ involvement requiring immunosuppressive therapy, e.g., pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis, recurrent malignant aneurysms), gastrointestinal (e.g., gastrointestinal ulcers), and central nervous system (e.g., meningoencephalitis).
. High-dose glucocorticoid (\>1mg/kg/d) usage within 1 month.
. Severe comorbidities: including Heart failure (≥ grade III NYHA); Renal insufficiency (creatinine clearance ≤30 ml/min); Hepatic insufficiency (serum ALT or AST \>3 times the ULN, or total bilirubin \>ULN for the central laboratory conducting the test).
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 was a Phase 2 trial specifically looking at how low-dose IL-2 affected the number of oral ulcers at 12 weeks — does the data that's come out of this completed trial suggest it actually reduced oral ulcers in Behcet's patients, and is that relevant to my situation?
2Since this trial is now completed, has the results data been published anywhere, and would you be able to walk me through what it found before we consider whether IL-2 therapy might be worth pursuing for me?
3Low-dose IL-2 works by trying to rebalance the immune system — how does that approach compare to the standard treatments I might already be a candidate for, like colchicine or immunosuppressants, in terms of what's known about safety and effectiveness in Behcet's?
4Because this was only Phase 2, what do we still not know about the long-term safety of low-dose IL-2 in Behcet's disease that a larger Phase 3 trial would normally establish?
5If low-dose IL-2 showed promising results in this trial for oral ulcers specifically, does that mean it might help with my other Behcet's symptoms, or was its benefit likely limited to that one outcome they were measuring?
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.
. Other severe, progressive or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
. Known allergies, hypersensitivity, or intolerance to IL-2 or its excipients.
. History of severe allergic reaction to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients.
. Had a severe infection (including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis); had been hospitalized for an infection; or had been treated with IV antibiotics for an infection, within 2 months prior to the first administration of study agent.
. Chest radiograph within 3 months prior to the first administration of study agent that showed an abnormality suggestive of a malignancy or current active infection, including TB.