Ivarmacitinib for Refractory Behcet's Syndrome (NCT07634848) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Ivarmacitinib for Refractory Behcet's Syndrome
China30 participantsStarted 2026-06-01
Plain-language summary
Behcet's syndrome (BS) is a multisystem autoimmune vasculitis. Current clinical treatment primarily includes glucocorticoids, immunosuppressants, and molecularly targeted drugs such as TNF-α and IL-6 inhibitors; however, some patients still respond poorly to existing treatment regimens. The JAK-STAT signaling pathway serves as a common downstream signaling pathway for various cytokines involved in the pathogenesis of Behcet's syndrome. Upon binding to their receptors, cytokines activate JAK kinases, which in turn phosphorylate STAT proteins to regulate the expression of inflammation-related genes. Therefore, blocking the JAK-STAT pathway can simultaneously inhibit the signal transduction of multiple pathogenic cytokines, thereby exerting anti-inflammatory effects. Consequently, Ivarmacitinib-a highly selective JAK1 inhibitor-holds promise for improving the prognosis and quality of life of patients with refractory Behçet's syndrome.
This is a multi-center, single-arm trial conducted to evaluate the safety and efficacy of Ivarmacitinib in Behçet's syndrome (BS) . Patients with refractory Behçet's syndrome were enrolled . Patients received Ivarmacitinib for up to 24 weeks, which was added to the glucocorticoid and immunosuppressants. The clinical manifestations, inflammatory indicators, imaging and treatment of patients were recorded by investigators during the follow up.
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:
* ① Meets the 1990 ISG diagnostic criteria for Behçet's syndrome \[9\];
* Aged 18-70 years; ③ Has shown an inadequate response to treatment after at least 6 months of therapy with glucocorticoids, at least two immunosuppressants, and/or biologics (including TNF-α inhibitors and IL-6 inhibitors);
* Agrees to receive treatment with a new targeted therapy
Exclusion Criteria:
* ① Patients with one or more other autoimmune diseases;
* Patients who have undergone major surgery within 4 weeks prior to enrollment, or who are scheduled to undergo elective surgery during the study; ③ Patients with a confirmed acute or chronic active infection (e.g., bacterial, viral \[such as EBV, CMV, HIV, or active hepatitis virus\]) within 4 weeks prior to enrollment; ④ Patients with a current or past history of any malignancy;
* Female patients who are pregnant or within 6 months postpartum;
* Patients with severe liver failure (Child-Pugh Class C) or end-stage renal disease (dialysis-dependent).
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 testing ivarmacitinib for Behcet's Syndrome that hasn't responded to other treatments, would my doctor consider my condition 'refractory' enough to potentially be worth discussing as an option?
2Because this is a Phase 2 trial, the researchers are still building evidence on safety and effectiveness — what do we actually know so far about how ivarmacitinib works in Behcet's Syndrome, and what unknowns should I be aware of?
3The trial is measuring complete and partial remission as its main goals — how would my doctor define what 'remission' would realistically look like for my specific symptoms, and is that a realistic target?
4Since the trial isn't recruiting yet, how long might it be before it opens, and are there standard treatments or other options I should be trying in the meantime rather than waiting?
5Given that this involves a JAK inhibitor class of drug targeting an autoimmune condition, what kinds of side effects or monitoring would typically be involved in a treatment like this, and how might that affect my day-to-day life during the trial?
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 and partial remission