Not Yet RecruitingPhase 2

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

China30 participantsStarted 2025-03-10

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Participants previously on other immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, iguratimod) should have withdrawn drug for at least 8 weeks (56 days) at the time of screening
✓. If the subject has evidence of new latent tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive the study drug.
✓. If female, the subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
✓. The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.

Exclusion criteria

✕. Pregnant or breastfeeding female.
✕. Diagnosis of other autoimmune disease, or other sicca syndrome.
✕. Laboratory value abnormality:

What they're measuring

Treatent response assessed by the Sjögren's Tool for Assessing Response (STAR)

Timeframe: week 24

Trial details

NCT IDNCT06862284

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Shiyu He

+86 19947570486 heshiyu@stu.pku.edu.cn

View on ClinicalTrials.gov More Primary Sjögren's Syndrome (pSS) trials