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
Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
Description
The study consists of the following periods: * Screening Period, with a duration of up to 6 weeks; * Treatment Period 1, with a duration of 52 weeks; * Treatment Period 2 (Open-label treatment), with a duration of 52 weeks; * Post-treatment Follow-up Period, with a duration of at least 20 weeks post last dose and up to 2 years.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers