At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Ustekinumabdrug
Likely dose
Ustekinumab 6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome
In Brief
A Phase 1 clinical trial evaluating Ustekinumab for Primary Sjögren Syndrome. Completed, enrolled 12 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sjögren Syndrome
CountriesUnited States
CollaboratorsJanssen, LP
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartJan 2020
Primary CompletionMay 2022
TodayJul 2026
First PostedSep 18, 2019
Enrollment StartJan 15, 2020
Primary CompletionMay 11, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.8 years ago
Interventions
Ustekinumabdrug
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.