A Study of INCB050465 in Primary Sjögren's Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2020-01-02

Brief Summary

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

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Detailed Description

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Conditions

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Primary Sjögren's Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parsaclisib

Group Type EXPERIMENTAL

Parsaclisib

Intervention Type DRUG

Parsaclisib administered orally once daily at the protocol-defined dose.

Interventions

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Parsaclisib

Parsaclisib administered orally once daily at the protocol-defined dose.

Intervention Type DRUG

Other Intervention Names

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INCB050465

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No