NCT04605978

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	S95011 concentrate for solution for infusion	IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
DRUG	Placebo concentrate for solution for infusion	IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Timeline

• Start date: 2021-08-03
• Primary completion: 2023-01-16
• Completion: 2023-05-09
• First posted: 2020-10-28
• Last updated: 2024-04-23
• Results posted: 2024-04-23

Locations

19 sites across 7 countries: United States, Australia, France, Germany, Hungary, Spain, United Kingdom

Regulatory

• FDA-regulated drug study