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A Study of INCB050465 in Primary Sjögren's Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of INCB050465 in Primary Sjögren's Syndrome

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

NCT03627065•Incyte Corporation

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (4)

Advanced Pharma CR

Miami, Florida, United States

North Georgia Rheumatology Group

Lawrenceville, Georgia, United States

The Center for Rheumatology and Bone Research

Wheaton, Maryland, United States

Ramesh C. Gupta, MD

Memphis, Tennessee, United States

Key Dates

Start Date

February 28, 2019

Primary Completion Date

December 7, 2019

Completion Date

January 2, 2020

Last Updated

August 13, 2021

Enrollment

ACTUAL participants

Conditions

Primary Sjögren's Syndrome

Interventions

Parsaclisib

DRUG

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

NCT06203457

Primary Sjögren's Syndrome

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COMPLETEDPHASE1

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome

NCT06484855

Primary Sjögren's Syndrome

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COMPLETEDPHASE2

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of INCB050465 in Primary Sjögren's Syndrome

Inclusion Criteria

Exclusion Criteria

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome

Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome