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Research and Clinical Trials

Title  
16M-MC-SSAD
Brief Description  
This study is a multicenter, parallel-group, randomized, double-blind, placebo-controlled, multiple ascending dose study in subjects with Sjögren's Syndrome. All eligible subjects will receive multiple doses of study drug or placebo over a period of 16 weeks and be followed up for an additional 12 weeks after the last dose. Up to 4 dose levels are planned for subcutaneous administration in a dose-escalation design.
Who may be Eligible  
Male and female adults aged 18 to 65; confirmed diagnosis of Sjögren's Syndrome by the American-European Consensus Group criteria with active disease (at any level), as per judgment of investigator (subjects with another concurrent, stable connective tissue disease may be eligible for inclusion, with written approval from the sponsor); Seropositive for Sjögren's syndrome antigen A or anti-SSB (Sjögren's syndrome antigen B) antibodies at screening, or documented within 6 months prior to screening.
Start Date  
12/16/2015
IRB Number  
12-15-04B
Principal Investigator  
Lam, Gordon
Contact Name  
Gordon

For More Information, Contact  Gordon  , Lam, MD
Phone:  (704) 403-1308  Fax:  (704) 403-1194  
Email:  Gordon.Lam@carolinashealthcare.org
Address:200 Medical Park Drive Concord, NC 28025
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