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NCT05113004Possibly a fitRecruiting

Testing new outcomes in primary Sjögren’s syndrome

Primary Sjögren's Syndrome (pSS)

Treatments studied

Part of Eyes & vision, Mouth & dental clinical trials.

This Phase 2 study tests how to measure changes in primary Sjögren’s syndrome symptoms and body activity. It may help researchers confirm which outcomes best reflect improvement and how different patient types respond to treatment.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
300 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be 18 years or older and able to sign written consent.
  • You must have primary Sjögren’s syndrome diagnosed by accepted criteria (ACR/EULAR 2016 or AECG 2002).
  • Your symptom level must be high (ESSPRI 5 or more) and your overall body inflammation level must be either lower (ESSDAI < 5) or moderate/high (ESSDAI 5 or more), depending on which group you fit.
  • If you can become pregnant, you must have a negative pregnancy test and use highly effective birth control during the study and for 2 years after stopping.
  • You must not be in another medicine trial at the same time.
  • You must not have certain eye, liver/kidney, infection, blood count, heart rhythm, or cancer conditions that could make the study unsafe.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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