Systemic sclerosis is a rare condition that causes hardening of the skin and can affect internal organs such as the lungs, heart, and kidneys. The study evaluates an oral medication called nerandomilast, which is designed to reduce disease activity, and compares it with a matching placebo pill that contains no active drug.
The purpose of the study is to determine whether nerandomilast can more effectively delay death or disease worsening compared with the placebo.
Participants will be randomly assigned to receive either the active medication or the placebo for about one year. During this time, they will attend regular clinic visits where doctors will check skin thickness, lung function (including a test called FVC that measures how much air can be forced out of the lungs), physical ability, and overall health. The study will track any serious health events, changes in symptoms, and overall survival throughout the treatment period.



Belgium
Bulgaria
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Lithuania
Norway
Portugal
Sweden
The Netherlands