CompletedPhase 2

Upadacitinib for Refractory Behcet's Syndrome

China27 participantsStarted 2024-01-25

Plain-language summary

Behçet's syndrome (BS) is a systemic autoimmune vasculitis that can affect multiple organs, including the skin, eyes, and vascular system. Refractory BS poses significant treatment challenges, necessitating novel therapeutic approaches. Upadacitinib, a selective JAK1 inhibitor within the JAK-STAT pathway, has shown promise in modulating immune responses. This study aims to evaluate the efficacy and safety of upadacitinib in patients with refractory BS.

Who can participate

Age range

18 Years – 80 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 aged 18-70 years at time of screening. * Diagnosis of Behcet's syndrome (according to the International Criteria for Behçet's Disease) for ≥3 months before screening. * Active Behcet's syndrome at time of screening (BDCAF≥2). * Resistant to glucocorticoids, at least two traditional immunosuppressants (one of which must have been cyclophosphamide or mycophenolate mofetil) or biological agents (one of which must have been a TNF-α inhibitor or a JAK inhibitor) for at least 6 months. * 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: * 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). 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 Baricitinib or its 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 antib…

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 is a Phase 2 trial for upadacitinib in Behcet's syndrome, what does that phase tell us about how much is known so far about its safety and effectiveness for this condition?
2The trial has already been completed — has my doctor seen or can they access any published results showing how many patients actually experienced meaningful improvement?
3Behcet's syndrome can affect different organs in different people — would my specific symptoms or disease involvement have matched the type of patients enrolled in this study?
4Are there standard treatments I should try first before considering a drug like upadacitinib, or does my situation suggest I might already be a candidate for something in this category?
5Upadacitinib works by suppressing part of the immune system — given my overall health, are there particular risks my doctor would want me to weigh carefully before discussing this option?

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

Patients getting improved condition

Timeframe: Week 24

Trial details

NCT IDNCT07080346

SponsorLiu Tian

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-20

View on ClinicalTrials.gov More Behcet Syndrome trials