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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
subcutaneous injections of 300mg every 2 weeks over a period of 12 weeks
Stanford University
Palo Alto, California, United States
whole unstimulated sialometry
change in unstimulated salivary flow
Time frame: baseline
whole unstimulated sialometry
change in unstimulated salivary flow
Time frame: week 12
salivary gland ultrasound
change in salivary gland ultrasound score
Time frame: baseline
salivary gland ultrasound
change in salivary gland ultrasound score
Time frame: week 12
ESSDAI
change in the ESSDAI disease activity score The EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity. The ESSDAI score is obtained by addition of the twelve domain scores. Each domain score is obtained by multiplying the activity level with the domain weight. The maximum theoretical ESSDAI score is 123 and the minimum score is 0. A higher score means more disease activity (worse outcome).
Time frame: baseline
ESSDAI
change in the ESSDAI disease activity score The EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity. The ESSDAI score is obtained by addition of the twelve domain scores. Each domain score is obtained by multiplying the activity level with the domain weight. The maximum theoretical ESSDAI score is 123 and the minimum score is 0. A higher score means more disease activity (worse outcome).
Time frame: week 12
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ESSPRI
change in the ESSPRI disease activity score The EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, fatigue, and pain). The ESSPRI score is calculated by averaging the three domains with a maximum severity score of 10 and minimum score of 0. A higher score means more disease activity (worse outcome).
Time frame: baseline
ESSPRI
change in the ESSPRI disease activity score The EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, fatigue, and pain). The ESSPRI score is calculated by averaging the three domains with a maximum severity score of 10 and minimum score of 0. A higher score means more disease activity (worse outcome).
Time frame: week 12
whole stimulated sialometry
change in stimulated salivary flow rate
Time frame: baseline
whole stimulated sialometry
change in stimulated salivary flow rate
Time frame: week 12
Schirmer I test
change in the Schirmer I test
Time frame: baseline
Schirmer I test
change in the Schirmer I test
Time frame: week 12
MRI
change in MRI (parenchymal architecture scored 0 to 4 and sialography scored 0 to 4)
Time frame: baseline
MRI
change in MRI (parenchymal architecture scored 0 to 4 and sialography scored 0 to 4)
Time frame: week 12
PET
change in PET (parotid and submandibular gland SUVmax)
Time frame: baseline
PET
change in PET (parotid and submandibular gland SUVmax)
Time frame: week 12