Clinical trial: BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome (NCT04684654)

Eligibility criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  BMI: 18.0 to 30.0 kg/m2, weight: ≥ 50 kg at screening

          -  Must agree to follow specific methods of contraception, if applicable

        Healthy Participants (Part A and Part B)

          -  Healthy male and female participants as determined by no clinically significant
             deviation from normal in medical history, physical examination (PE),
             electrocardiograms (ECGs), and clinical laboratory determinations

          -  Males and Females, ages 18, or local age of majority, to 50 years, inclusive at
             screening

        Participants with Sjögren's Syndrome (Part C)

          -  Sjögren's syndrome in the absence of another immune-mediated disease or rheumatologic
             condition based on the 2016 American College of Rheumatology-European League Against
             Rheumatism (EULAR) Classification Criteria for primary Sjögren's syndrome (pSS)

          -  Seropositive for anti-Sjögren's syndrome antigen A antibody

          -  Males and females, ages 18, or local age of majority, to 65 years, inclusive at
             screening

        Exclusion Criteria:

          -  Woman who are pregnant or breastfeeding

          -  Inability to tolerate venipuncture and/or inadequate venous access

        Healthy Participants (Part A and Part B)

          -  Any significant acute or chronic medical illness

          -  Any other significant medical, psychiatric, and/or social reason as determined by the
             investigator

        Participants with Sjögren's Syndrome (Part C)

          -  Systemic immune-mediated disease other than pSS, such as rheumatoid arthritis (RA),
             systemic lupus erythematosus (SLE), mixed connective tissue disease, or systemic
             sclerosis, that can better explain the majority of the symptoms (i.e., secondary
             Sjögren's syndrome)

          -  Another immune-mediated disease or inflammatory condition that could interfere with
             assessment of response of pSS to therapy (e.g., immunoglobulin G4 (IgG4)-related
             disease, systemic sclerosis, inflammatory bowel disease, gout)

          -  Any other medical condition associated with sicca syndrome (e.g., history of head and
             neck radiation treatment, diabetes mellitus, sarcoidosis, chronic graft-versus host
             disease), participants with sicca symptoms secondary to ongoing medication use based
             on the investigator's assessment

        Other protocol-defined inclusion/exclusion criteria apply
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment