Sjogren's Syndrome

A Study of INCB050465 in Primary Sjögren's Syndrome

Incyte Study ID:
INCB 50465-207
CT.gov ID:
NCT03627065
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

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

Clinical Study Summary

MEDICAL CONDITION(S)
  • Sjogren's Syndrome
    • PRODUCT
  • Drug: Parsaclisib
    • COLLABORATORS
    N/A
    DATE
    Feb 2019 - Dec 2019
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion 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.

    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.

    Clinical Study Locations

    Location
    Status
    Location
    Advanced Pharma CR
    Miami, Florida, US, 33147
    Status
    Active, not recruiting
    Location
    North Georgia Rheumatology Group
    Lawrenceville, Georgia, US, 30046
    Status
    Active, not recruiting
    Location
    The Center for Rheumatology and Bone Research
    Wheaton, Maryland, US, 20902
    Status
    Active, not recruiting
    Location
    Ramesh C. Gupta, MD
    Memphis, Tennessee, US, 38119-5208
    Status
    Active, not recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 50465-207
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    10
    Primary Outcome
    Open

    Proportion of participants with a 1 point or greater change on the salivary gland ultrasound (SGUS) score for parotid and submandibular glands

    Timeframe: Week 4 and Week 12

    Secondary Outcome
    Open

    Change from baseline in salivary CXCL13 levels

    Timeframe: Baseline, Week 4 and Week 12

    Number of treatment-emergent adverse events

    Timeframe: Up to 21 weeks

    Whole Salivary Flow

    Timeframe: Weeks 4, 8, and 12

    EULAR Sjögren's Syndrome Disease Activity Index

    Timeframe: Week 12

    EULAR Sjögren's Syndrome Patient Reported Index

    Timeframe: Weeks 4, 8, and 12

    Symptom Scores for Dryness

    Timeframe: Weeks 4, 8, and 12.

    Patient Global Impression of Change Questionnaire

    Timeframe: Weeks 4, 8, and 12

    PROMIS Fatigue Short Form

    Timeframe: Weeks 4, 8, and 12

    Female Participants only : Female Sexual Function Index

    Timeframe: Weeks 4, 8, and 12

    European Quality of Life 5 Dimensions Questionnaire

    Timeframe: Weeks 4, 8, and 12