At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
S95011 concentrate for solution for infusion +1 moredrug
Likely dose
Not stated in 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.
A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study
Institut de Recherches Internationales Servier·interventional·Posted Oct 28, 2020·Updated Apr 23, 2024
In Brief
A Phase 2 clinical trial evaluating S95011 concentrate for solution for infusion and Placebo concentrate for solution for infusion for Primary Sjögren's Syndrome. Completed, enrolled 48 participants across 19 sites in 7 countries.
Detailed Summary
The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sjögren's Syndrome
CountriesAustralia, France, Germany, Hungary, Spain, United Kingdom, United States
CollaboratorsADIR, a Servier Group company
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartAug 2021
Primary CompletionJan 2023
Study CompletionMay 2023
TodayJul 2026
First PostedOct 28, 2020
Enrollment StartAug 3, 2021
Primary CompletionJan 16, 2023
Study CompletionMay 9, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.7 years ago
Interventions
S95011 concentrate for solution for infusiondrug
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Placebo concentrate for solution for infusiondrug
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.