A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis

A new drug called tibulizumab is being tested in people with systemic sclerosis to see if it can slow or reverse the thickening of their skin and protect their lungs from damage. Systemic sclerosis is a chronic autoimmune disease that causes the body to produce too much collagen, leading to hard, tight skin and, in many cases, progressive scarring of the lungs. This lung damage is the leading cause of death in the condition. Current treatments are limited and often fail to stop the disease from worsening. This trial directly addresses that gap by testing whether tibulizumab—a dual-action antibody that blocks two inflammatory pathways—can improve both skin and lung outcomes in a controlled, rigorous way. If the drug proves effective, it could offer the first treatment option that simultaneously tackles the skin thickening and the life-threatening lung fibrosis that define the most severe forms of the disease. The study also tracks quality of life and side effects, so any future use would be grounded in real-world safety data. For patients with systemic sclerosis, who currently face a progressive decline with few effective therapies, even a modest slowing of lung damage would represent a meaningful change in their prognosis.