Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Sponsor
Peking University People's Hospital
Study ID
NCT06862284
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Primary Sjögren's Syndrome (pSS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib (ABT-494) — DRUG
    Upadacitinib 15mg Qd for 52 weeks
  • Hydroxychloroquine (HCQ) — DRUG
    Hydroxychloroquine 200mg Bid for 52 weeks

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Dec 2024
Primary completion
Dec 30, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: upadacitinib group
    Participants will receive upadacitinib 15 milligrams (mg) orally once daily for 52 weeks.
  • Active Comparator: hydroxychloroquinone group
    Participants will receive hydroxychloroquine 200 milligrams (mg) orally twice daily for 52 weeks.

Primary Outcome Measure

Treatent response assessed by the Sjögren's Tool for Assessing Response (STAR) [ Time Frame: week 24 ]

Central Contacts