A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of Ianalumab in Adults With Diffuse Cutaneous Systemic Sclerosis

What this Trial Is About

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a serious autoimmune condition. This Phase 2 study compares ianalumab against a placebo to better understand its effects on this disease. The study is sponsored by Novartis Pharmaceuticals and aims to assess how ianalumab impacts disease activity and progression. The study includes multiple periods a screening period lasting up to 6 weeks a first treatment period of 52 weeks where participants receive either ianalumab or placebo injections followed by a second open-label treatment period of an additional 52 weeks where all participants receive ianalumab. After treatment, there is a post-treatment follow-up period lasting at least 20 weeks and up to 2 years to monitor long-term effects. Participants will undergo regular assessments including measuring their response using the 35 rCRISS25 scale at Week 52, lung function changes, skin thickness scores, and physical disability indexes. Blood samples will be collected throughout the study to monitor drug levels and antibodies. Safety is closely monitored by recording any adverse events during the entire study duration, which can last up to 208 weeks. The study involves detailed clinical evaluations and laboratory tests to fully assess the impact of ianalumab on this condition.

A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis