Systemic sclerosis (systemic scleroderma) is a rare autoimmune disease that causes progressive fibrosis of the skin and internal organs — especially the lungs, heart, kidneys, and digestive tract — along with widespread small blood vessel damage. Outcomes vary widely and the most severe pulmonary and cardiac involvement carries a poor prognosis.
What's actually going on in research
Nintedanib, an antifibrotic drug used in pulmonary fibrosis, is now standard for scleroderma-associated interstitial lung disease after showing it slows lung function decline. Autologous stem cell transplant has shown durable benefit in carefully selected patients with early diffuse scleroderma. Tocilizumab (an IL-6 inhibitor) has shown benefit for the lung disease and is in ongoing trials. Newer anti-fibrotic approaches targeting TGF-beta, B-cell depletion, and the type I interferon pathway are in trials.
Nintedanib for lung disease
This antifibrotic drug slows the progression of interstitial lung disease in systemic sclerosis and is being combined with other immunosuppressives in trials to achieve additive benefit.
Autologous stem cell transplant
For young patients with rapidly progressive diffuse disease, high-dose immunosuppression followed by stem cell rescue offers durable disease control in carefully selected patients.
Anti-IL-6 therapy
Tocilizumab reduces progression of scleroderma lung disease and skin thickening in trials, and further studies are defining who benefits most and combining it with antifibrotic drugs.
What to know before you search
Eligibility depends on disease subtype (limited vs. diffuse), skin score, lung function, pulmonary hypertension status, specific autoantibodies (anti-Scl70, anti-centromere), and disease duration.
What types of trials are currently open
- Anti-fibrotic drug trials — Testing drugs targeting fibrosis pathways including TGF-beta, nintedanib, and novel agents.
- Immunosuppression trials — Evaluating mycophenolate, rituximab, and tocilizumab for skin and lung disease.
- Stem cell transplant trials — Comparing stem cell transplant criteria, conditioning, and long-term outcomes in diffuse systemic sclerosis.
- Pulmonary hypertension trials — Testing PAH treatments in scleroderma-associated pulmonary arterial hypertension.
- Raynaud's and vascular trials — Evaluating drugs and devices for Raynaud's phenomenon and digital ulcers.
Recently added Systemic Sclerosis trials
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial.
MTS109 in Patients With Refractory Autoimmune Diseases
This is the first-in-human trial of MTS109 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS109 in moderate to severe autoimmune diseases.
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