A Study of INCB050465 in Primary Sjögren's Syndrome

• Status: Completed
• Trial end date: 2020-01-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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.