NCT02038049

A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis

A Randomized, Partially Blind, Placebo-controlled, Proof-of-concept Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity as Measured by Brain MRI Scans in Patients With Relapsing-remitting Multiple Sclerosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).

Detailed description

The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.

Conditions

• Relapse Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	VAY736	Single intravenous infusion of VAY736 (10 mg/kg)
DRUG	Placebo	Placebo to VAY736

Timeline

• Start date: 2013-12-20
• Primary completion: 2015-05-05
• Completion: 2018-09-13
• First posted: 2014-01-16
• Last updated: 2021-01-05
• Results posted: 2019-10-30

Locations

5 sites across 3 countries: United States, Czechia, Ukraine

Regulatory

• FDA-regulated drug study