NCT04563195

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Matthew C. Baker · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	tibulizumab (LY3090106)	subcutaneous injections of 300mg every 2 weeks over a period of 12 weeks

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-12-01
• Completion: 2025-01-01
• First posted: 2020-09-24
• Last updated: 2022-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study