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

NCT04605978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-04-23

Study results available
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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

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.

Sponsors & Collaborators

  • ADIR, a Servier Group company

    collaborator INDUSTRY

  • Institut de Recherches Internationales Servier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2023-01-16
Completion
2023-05-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Hungary
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04605978 on ClinicalTrials.gov