A Study of Parsaclisib in Primary Sjögren's Syndrome

Inclusion Criteria:

- Primary SS diagnosed according to the revised American-European Consensus Group (AECG)
criteria.

- Minimum score of 2 on the SGUS score for parotid and submandibular glands.

- EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 5.

- Positive serum titers of anti-SS-A and/or anti-SS-B antibodies.

- Symptomatic oral dryness score of at least 5 on patient questionnaire.

- Willingness to avoid pregnancy or fathering children based on protocol-defined
criteria.

Exclusion Criteria:

- Diagnosis of secondary SS according to the revised AECG criteria (eg, the presence of
a previously diagnosed or a present diagnosis of rheumatoid arthritis, systemic lupus
erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis,
dermatomyositis, immunoglobulin G4-related disorder, sarcoidosis, or any other defined
autoimmune rheumatologic disorder).

- Concurrent conditions and history of other diseases per protocol-defined criteria.

- Positive test results for tuberculosis (TB) from the QuantiFERON-TB Gold test or
T-spot.TB test.

- Positive serology test results for HIV antibody, hepatitis B surface antigen,
hepatitis B surface antigen antibody, HBV core antibody, or HCV (HCV antibody with
positive HCV-RNA).

- Severely impaired liver function (Child-Pugh Class C).

- Prior or ongoing therapy with protocol-defined drugs.

- Receipt of any live vaccine in the 30 days before screening.

- No major surgery within 30 days before screening. Inadequate recovery from toxicity
and/or complications from a major surgery before starting therapy.

- Current alcohol or drug use that, in the opinion of the investigator, will interfere
with the participant's ability to comply with the dose regimen and study evaluations.

- Laboratory values at screening outside the protocol-defined ranges.