NCT07080346

Upadacitinib for Refractory Behcet's Syndrome

Upadacitinib for Refractory Behcet's Syndrome: a Prospective Pilot Open-label Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Liu Tian · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This multicenter, single-arm study investigates the efficacy and safety of upadacitinib (15 mg once daily) in refractory Behçet's syndrome (BS) patients. Adult patients had active BS with inadequate response to glucocorticoids and at least two conventional immunosuppressants or biologics over six months. Prior biologics were discontinued, and upadacitinib was added to ongoing glucocorticoids and immunosuppressants for 48 weeks. Clinical symptoms (oral/genital ulcers, skin lesions, uveitis), inflammatory markers (CRP, ESR), and medication usage were monitored. Adverse events were recorded to assess safety.

Conditions

• Behcet Syndrome

Interventions

Type	Name	Description
DRUG	Upadacitinib 15 MG	All the BS patients discontinued other biologic agents and received oral upadacitinib treatment at a dose of 15mg per day with background glucocorticoids and immunosuppressants for 48 weeks. All the patients will be followed up prospectively for 48 weeks.

Timeline

• Start date: 2024-01-25
• Primary completion: 2024-12-20
• Completion: 2025-07-08
• First posted: 2025-07-23
• Last updated: 2025-12-02

Locations

1 site across 1 country: China