PD of VAY736 in Patients With Primary Sjögren's Syndrome — CVAY736X2201  

Primary Sjögren's Syndrome Clinical Trial

Official title: 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

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. ;

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

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