NCT06862284

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Efficacy, Safety and Immunological Effect of Upadacitinib in the Treatment of Primary Sjögren's Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to explore the efficacy and safety of upadacitinib and clarify the influence on immune function in the treatment of primary Sjögren's Syndrome.

Detailed description

This is an open-label, single-center, randomized controlled trial of upadacitinib in the treatment of active primary Sjögren's Syndrome. The enrollment was based on the American College of Rheumatology(ACR) and European League Against Rheumatism (EULAR)(2016) diagnostic criteria. The efficacy and safety were evaluated in participants given upadacitinib 15mg/day and a proper, stable dose of hydroxychloroquine 400mg/day. Changes in clinical manifestation, laboratory indexes, and immunological indicators were explored in the process.

Conditions

• Primary Sjögren's Syndrome (pSS)

Interventions

Type	Name	Description
DRUG	Upadacitinib (ABT-494)	Upadacitinib 15mg Qd for 52 weeks
DRUG	Hydroxychloroquine (HCQ)	Hydroxychloroquine 200mg Bid for 52 weeks

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-12-30
• Completion: 2027-08-31
• First posted: 2025-03-06
• Last updated: 2025-03-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study