NCT02149420

PD of VAY736 in Patients With Primary Sjögren's Syndrome

A Single Dose, Double-blind, Placebo-controlled, Parallel Study to Assess the Pharmacodynamics, Pharmacokinetics and Safety and Tolerability of VAY736 in Patients With Primary Sjögren's Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	VAY736
DRUG	Placebo

Timeline

• Start date: 2014-05-23
• Primary completion: 2018-02-07
• Completion: 2018-02-07
• First posted: 2014-05-29
• Last updated: 2021-10-04
• Results posted: 2019-02-12

Locations

1 site across 1 country: Germany