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Clinical Trial Summary

This study was designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients


Clinical Trial Description

Patients were enrolled in 2 sequential cohorts: Cohort 1: 6 patients received 3 mg/kg or Placebo (2:1 ratio) Cohort 2: 21 patients received 10 mg/kg, 3 mg/kg or Placebo (6:1:3 ratio) At week 24 the blind was broken to assess continuation in the trial: - If a patient received VAY736 and their B cell recovery was demonstrated at Week 24, then patients completed the trial. - If a patient received VAY736 and their B cell recovery was NOT demonstrated at Week 24, then patients were followed up until B cell recovery was demonstrated - If a patient received placebo, they were offered the option of receiving open-label VAY736 (10 mg/kg) in a separate treatment arm. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02149420
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date May 23, 2014
Completion date February 7, 2018

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