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This pilot study will make a preliminary determination of the safety of ustekinumab in patients with Primary Sjogren's Syndrome (PSS) and assess the response of systemic measures of inflammation (biomarkers).
This is a single-center, open label, pilot trial of ustekinumab in patients with Primary Sjögren's Syndrome (PSS). Up to 15 subjects will receive an infusion loading dose of 6 mg/kg of ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and week 20. Subjects will be followed for 24 weeks.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
University of Rochester
Rochester, New York, United States
Start Date
January 15, 2020
Primary Completion Date
May 11, 2022
Completion Date
May 11, 2022
Last Updated
June 25, 2024
12
ACTUAL participants
Ustekinumab
DRUG
Lead Sponsor
University of Rochester
Collaborators
NCT06440525
NCT06528197
NCT06049368
Data Source & Attribution
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