Upadacitinib for Refractory Behcet's Syndrome (NCT07080346) | Clinical Trial Compass
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 range18 Years – 80 Years
SexALL
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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…