Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Male or female >18 years of age at screening visits

Participants with diagnosis of pSS according to the 2016 ACR/EULAR criteria

Participants have an ESSDAI score ≥ 5

Participants must be on a stable dose of prednisone (≤10mg/day), antimalarials or equivalent, and cholinergic stimulants prior to Baseline.

Disqualifiers

Pregnant or breastfeeding female.

Diagnosis of other autoimmune disease, or other sicca syndrome.

Trial design

Treatments tested in this trial

  • Upadacitinib (ABT-494)
  • Hydroxychloroquine (HCQ)

Treatment groups

30 Participants
are divided into 2 treatment groups