A Study of Parsaclisib in Primary Sjögren's Syndrome



Status:Recruiting
Conditions:Rheumatology
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:September 24, 2018
End Date:September 2019
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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An Open-Label Phase 2 Study of Parsaclisib 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.
We found this trial at
3
sites
Memphis, Tennessee 38119
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Memphis, TN
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Lawrenceville, Georgia 30046
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Lawrenceville, GA
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Miami, Florida 33175
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Miami, FL
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