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To demonstrate that tibulizumab (LY3090106) treatment improves the mean unstimulated salivary flow rate or the salivary gland total ultrasound score (TUS) in primary Sjogren's syndrome patients at week 12 compared to the baseline visit.
Full description
This will be a single-site, open-label study in patients with primary Sjogren's syndrome. All patients will receive tibulizumab (LY3090106) 300mg subcutaneously every 2 weeks for a total of 12 weeks.
Primary Sjogren's syndrome was selected as a relevant patient population based on the mechanism of action of the molecule and the current understanding of the pathogenesis of the disease. An open-label design was chosen based on practical considerations regarding the number of patients that could be recruited. Although open-label studies are subject to bias, objective primary endpoints were intentionally chosen to minimize this concern.
The goal of this study is to demonstrate that tibulizumab (LY3090106) treatment improves the mean unstimulated salivary flow rate or the salivary gland total ultrasound score (TUS) in primary Sjogren's syndrome patients at week 12 compared to the baseline visit.
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Inclusion criteria
Exclusion criteria
Currently enrolled in a clinical trial involving an investigational product or off-label use of a drug
Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have received any nonbiologic investigational product within 30 days or 5 half-lives (whichever is longer) of their baseline (Day 1) visit
Have received any biologic investigational product within 3 months or 5 half-lives (whichever is longer) of their baseline visit, or any leukocyte depleting agent within 12 months of baseline
Have disease-modifying antirheumatic drug (DMARD) or immunosuppressive use as follows:
Are persons who have previously completed or withdrawn from this study
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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