Nemolizumab Treatment Study for Adults with Systemic Sclerosis A 52-Week Randomized, Placebo-Controlled, Dose-Finding Phase 2 Trial

What this Trial Is About

Researchers are evaluating the effects of Nemolizumab on skin thickness and safety in adults with systemic sclerosis over a 52-week treatment period. The study aims to find the best dose for this group of patients. It is a randomized, double-blind, placebo-controlled Phase 2 trial sponsored by Galderma R&D, focusing on systemic sclerosis, a condition affecting skin and internal organs. Participants will receive subcutaneous injections of either one of two doses of Nemolizumab or a placebo. The trial includes a 52-week treatment period during which patients are monitored closely for changes in skin thickness and lung function. The study also tracks safety and tolerability through various assessments throughout and up to 12 weeks after the last dose. During the study, participants will undergo regular evaluations including skin scoring with the Modified Rodnan Skin Score, lung function tests like forced vital capacity, and questionnaires assessing disability and global health. Safety monitoring includes checking for adverse events, vital signs, laboratory tests, ECGs, and weight changes. The total participation time covers the 52-week treatment and the follow-up period, allowing thorough observation of treatment effects and safety.

A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis