BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome — BAFF/IL-17  

Primary Sjogren's Syndrome Clinical Trial

Official title: BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Primary Sjogren's Syndrome
• Sjogren's Syndrome
• Syndrome

• NCT number: NCT04563195
• Study type: Interventional
• Source: Stanford University
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: February 1, 2022
• Completion date: January 2025