- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07634848
Ivarmacitinib for Refractory Behcet's Syndrome
Efficacy and Safety of the Novel, Highly Selective JAK Inhibitor Ivarmacitinib in the Treatment of Behçet's Disease: A Multicenter Prospective Study
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.
Studieöversikt
Studietyp
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina
- Department of Rheumatology and Immunology, Peking University People's Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Ivarmacitinib for the Treatment of Refractory Behçet's Disease
|
The specific regimen was 4 mg of Ivarmacitinib administered daily for 24 weeks.
All patients will undergo 24 weeks of prospective follow-up.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patienter som uppnår fullständig remission och partiell remission
Tidsram: Vecka 24
|
Det primära effektmåttet definierades som andelen (procent) patienter i hela kohorten som uppnådde fullständig remission och partiell remission senast vecka 24.
|
Vecka 24
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes of C-reactive protein
Tidsram: Week 24
|
Blood samples were collected from all patients and the concentration of C-reactive protein (mg/L) were recorded.
|
Week 24
|
|
Changes of erythrocyte sedimentation rate
Tidsram: week24
|
Blood samples were collected from all patients and the erythrocyte sedimentation rates (mm/h) were recorded.
|
week24
|
|
Changes of dosage of glucocorticoids from baseline.
Tidsram: week 24
|
The dosage of glucocorticoids (mg/day) of all patients were recorded during the follow-up.
|
week 24
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Munsjukdomar
- Stomatogena sjukdomar
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Genetiska sjukdomar, medfödda
- Ögonsjukdomar
- Hudsjukdomar
- Hudsjukdomar, vaskulära
- Hudsjukdomar, genetiska
- Uveal sjukdomar
- Vaskulit
- Panuveit
- Uveit, främre
- Uveit
- Ärftliga autoinflammatoriska sjukdomar
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Hud- och bindvävssjukdomar
- Behcets syndrom
- ivarmacitinib
Andra studie-ID-nummer
- PKU People's Hospital SHR0302
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .