NCT04093531

Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Primary Sjögren Syndrome

Interventions

Type	Name	Description
DRUG	Ustekinumab	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.

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-05-11
• Completion: 2022-05-11
• First posted: 2019-09-18
• Last updated: 2024-06-25
• Results posted: 2024-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study