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A Study of INCB050465 in Primary Sjögren's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03627065
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : September 16, 2019
Information provided by (Responsible Party):
Incyte Corporation

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

Condition or disease Intervention/treatment Phase
Primary Sjögren's Syndrome Drug: Parsaclisib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Study of INCB050465 in Participants With Primary Sjögren's Syndrome
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Parsaclisib Drug: Parsaclisib
Parsaclisib administered orally once daily at the protocol-defined dose.
Other Name: INCB050465

Primary Outcome Measures :
  1. Proportion of participants with a 1 point or greater change on the salivary gland ultrasound (SGUS) score for parotid and submandibular glands [ Time Frame: Week 4 and Week 12 ]
    To determine the impact of parsaclisib on salivary gland echostructure.

Secondary Outcome Measures :
  1. Change from baseline in salivary CXCL13 levels [ Time Frame: Baseline, Week 4 and Week 12 ]
    To assess the impact of parsaclisib on salivary CXCL13.

  2. Number of treatment-emergent adverse events [ Time Frame: Up to 21 weeks ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03627065

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Contact: Incyte Corporation Call Center (US) 1.855.463.3463

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United States, Florida
Advanced Pharma CR Recruiting
Miami, Florida, United States, 33147
United States, Georgia
North Georgia Rheumatology Group Recruiting
Lawrenceville, Georgia, United States, 30046
United States, Maryland
The Center for Rheumatology and Bone Research Recruiting
Wheaton, Maryland, United States, 20902
United States, Tennessee
Ramesh C. Gupta, MD Recruiting
Memphis, Tennessee, United States, 38119-5208
Sponsors and Collaborators
Incyte Corporation
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Study Director: Kathleen Butler, MD Incyte Corporation

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Responsible Party: Incyte Corporation Identifier: NCT03627065     History of Changes
Other Study ID Numbers: INCB 50465-207
Parsaclisib ( Other Identifier: Incyte Corporation )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Primary Sjögren's syndrome
PI3Kδ inhibitor
Additional relevant MeSH terms:
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Mouth Diseases
Dry Eye Syndromes
Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases