Last updated on January 2019

An Open-Label Phase 2 Study in Participants with Primary Sjogren's Syndrome


Brief description of study

Primary Outcome Measures:

  • 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 INCB050465 on salivary gland echostructure.

Secondary Outcome Measures:

  • Change from baseline in salivary CXCL13 levels [ Time Frame: Baseline, Week 4 and Week 12 ]
  • To assess the impact of INCB050465 on salivary CXCL13.

 

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.

 

 

Clinical Study Identifier: TX217911

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