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
A Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.
A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).
CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease
This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard "3+3" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .
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