ONO-4915 in Patients With Primary Sjogren's Disease

Inclusion criteria

• Age (at the time of informed consent): >=18 and <75 years
• Patients who meet the criteria for primary Sjogren's disease defined by the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome
• Patients with positive anti-SS-A/Ro antibody in the screening period
• Patients with ESSPRI score of >=5 and dry symptom score of >=5 in the screening period
• Patients with stimulated salivary secretion rate of >=0.1 mL/min by the Saxon test in the screening period.
• Patients diagnosed with primary Sjogren's disease within 10 years

Exclusion criteria

• Patients with other concurrent autoimmune diseases
• Patients who may overlap with the clinical symptoms of primary Sjogren's disease or interfere with the evaluation of the clinical symptoms
• Patients with any disease that may interfere with the evaluation of dry symptoms of primary Sjogren's disease
• Patients with any disease that may interfere with the evaluation of pain of primary Sjogren's disease
• Patients with severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease unrelated to the primary disease
• Patients with current malignancy or history of malignancy within 5 years before the start of screening
• Patients with active infection