CVAY736S12201: Phase II study of ianalumab (VAY736) in dcSSc
Research type
Research Study
Full title
A randomized, double-blind, parallel group, placebo-controlled multicenter study to evaluate efficacy, safety and tolerability of ianalumab in participants with diffuse cutaneous systemic sclerosis
IRAS ID
1009382
Contact name
Theresa Vavvas
Contact email
Sponsor organisation
Novartis Pharma AG
ISRCTN Number
-
Clinicaltrials.gov Identifier
Research summary
The goal of this study is to find out if a new medicine called VAY736 (ianalumab) is safe and works well for adults with a condition called diffuse cutaneous systemic sclerosis (dcSSc). dcSSc is a disease in which the immune system mistakenly attacks different parts of a person’s
own body causing swelling and harm to important organs including kidneys, digestive system, lungs, and heart. This disease gets worse over time and causes the skin to become thicker. Ianalumab is a monoclonal antibody. This medicine sticks to a protein found on our B cells
which is involved in the development and progression of dcSSc. By attaching to these B cells, ianalumab might be able to make the dcSSc condition better by reducing their activity and number.REC name
Wales REC 5
REC reference
25/WA/0020
Date of REC Opinion
13 Feb 2025
REC opinion
Further Information Favourable Opinion