Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-26 @ 3:47 PM
Study NCT ID:
NCT04563195
Status:
WITHDRAWN
Last Update Posted:
2022-01-27
First Post:
2020-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome
Sponsor:
Matthew C. Baker
Organization:
Study Overview
Official Title:
BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAFF/IL-17
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: