Clinical trial: A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (NCT04700280)

Eligibility criteria:
Key Inclusion Criteria:

          1. Documented diagnosis of primary Sjögren's Syndrome (pSS) for <10 years prior to
             screening AND defined by the classification criteria >=4 described by the American
             College of Rheumatology - European League Against Rheumatism (ACR-EULAR).

          2. Participant has an ESSDAI score >=5 assessed on 7 domains: constitutional,
             lymphadenopathy, glandular, articular, cutaneous, hematological, and biological.

          3. Participant has an ESSPRI score >=5.

          4. Participant has stimulated whole salivary flow rate of >=0.1 mL/min.

          5. Participant has positive serum titers of anti-Sjögren's-syndrome-related antigen A
             (anti-SS-A)/Ro and/or anti-SS-B/La antibodies.

          6. Participants already on treatment should be on stable standard of care (SoC) for at
             least 4 weeks prior to first investigational product (IP) dosing.

             The following SoC medications are permitted:

               -  Corticosteroids <=7.5 mg/day (prednisone or equivalent); AND/OR

               -  Non-steroidal anti-inflammatory drugs (NSAIDs); AND/OR

               -  One single antimalarial at a stable dose (hydroxychloroquine <=400 mg/day;
                  quinacrine 100 mg/kg/day, or chloroquine <=250 mg/day); AND/OR

               -  One single immunosuppressant at a stable dose (methotrexate [MTX] <=10 mg/week or
                  azathioprine [AZA] <=2 mg/kg/day); AND/OR

               -  One single cholinergic stimulant at a stable dose (e.g., pilocarpine,
                  cevimeline).

          7. Female participant of childbearing potential must have a negative highly sensitive
             (serum beta human chorionic gonadotropin or urine dipstick) pregnancy test.

          8. Female participant of childbearing potential or male participant must agree to use
             highly effective contraception/preventive exposure measures.

        Key Exclusion Criteria:

          1. Secondary Sjögren's syndrome according to the ACR-EULAR (2016) classification.

          2. History or presence of unstable condition not related to Sjögren's Syndrome that, in
             the opinion of the investigator, could constitute an unacceptable risk when taking the
             IP or interfere with the interpretation of data.

          3. Participant has any active systemic infection within 2 weeks prior to first IP dosing,
             or poorly controlled chronic cardiac, pulmonary, or renal disease.

          4. Participant has a known or suspected history of or a current immunosuppressive
             condition, or a history of opportunistic infections (e.g., human immunodeficiency
             virus [HIV] infection, histoplasmosis, listeriosis, coccidioidomycosis,
             pneumocystosis, aspergillosis).

          5. Participant has a chronic hepatitis B virus (HBV) infection, as defined by persistent
             HBV surface antigen (HBsAg) positivity. Participant has hepatitis C virus (HCV)
             infection, as defined by positive HCV antibody at screening and detectable HCV
             viremia. Participants with positive HCV antibody must undergo reflex HCV ribonucleic
             acid (RNA) testing, and participants with HCV RNA positivity will be excluded.
             Participants with positive HCV antibody and negative HCV RNA are eligible.

          6. Participant testing positive for severe acute respiratory syndrome coronavirus 2
             (SARS-CoV-2) infection as detected at screening based on real time polymerase chain
             reaction (RT-PCR) or at baseline based on immunoglobulin M (IgM) immunoassay, or
             participants who have been in contact with SARS-CoV-2 infected individuals in the 2
             weeks prior to first dosing of IP. Participants presenting any signs or symptoms of
             SARS-CoV-2 infection, as detected at screening or baseline following careful physical
             examination (e.g., cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia,
             dysgeusia, anorexia, sore throat, etc). In addition, any other locally applicable
             standard diagnostic criteria may also apply to rule out SARS-CoV-2 infection.

          7. Participant has taken any disallowed therapies before the planned first dose of IP:

               -  Mycophenolate mofetil (MMF) within a week prior to screening.

               -  Cyclosporine/Tacrolimus within a week prior to screening.

               -  Cyclophosphamide within 6 months prior to screening.

               -  Ocular medicines (e.g., topical cyclosporine, topical NSAIDs/ corticosteroids)
                  for at least 4 weeks prior to screening, except for a sporadic use.

               -  Biologics such as, but not limited to, rituximab, abatacept, and any other
                  unapproved biologic within 6 months prior to screening.

               -  Plasmapheresis within 12 weeks prior to screening.

               -  Plasma exchange within 12 weeks prior to screening.

               -  Intravenous immunoglobulin (IVIG) therapy within 24 weeks prior to screening.

          8. Concurrent use of anticholinergic agents that, in the opinion of the investigator, are
             a contributing factor to the participant's dryness.

          9. Participant has a history of tuberculosis (TB) diagnosis or evidence of active or
             latent infection with Mycobacterium tuberculosis.

         10. Participant has a history of lymphoma or any malignancy within the past 5 years prior
             to screening with the exception of excised and curatively treated non-metastatic basal
             cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of cervix
             which is considered cured with minimal risk of recurrence.

        Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 74 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? 1