drugset / Trial / NCT04605978

Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

NCT04605978 ↗

Phase 2 Completed 48 enrolled Servier ADIR, a Servier Group company · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-08-03
Primary completion
2023-01-16
Completion
2023-05-09

Outcome

Missed primary endpoint

registry analysis (superiority test); S95011 Concentrate for Solution for Infusion; Mean Difference (Net) 2.44 (95% CI -0.61 to 5.49) NCT04605978 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject S95011 Unknown — Intravenous

Indications