A Study of INCB050465 in Primary Sjögren's Syndrome

An Open-Label Phase 2 Study of INCB050465 in Participants With Primary Sjögren's Syndrome

The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).

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.