A Study of INCB050465 in Primary Sjögren's Syndrome
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|ClinicalTrials.gov Identifier: NCT03627065|
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Sjögren's Syndrome||Drug: Parsaclisib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Parsaclisib administered orally once daily at the protocol-defined dose.
Other Name: INCB050465
- 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.
- Change from baseline in salivary CXCL13 levels [ Time Frame: Baseline, Week 4 and Week 12 ]To assess the impact of parsaclisib 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03627065
|Contact: Incyte Corporation Call Center (US)||firstname.lastname@example.org|
|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|
|Study Director:||Kathleen Butler, MD||Incyte Corporation|