Scleroderma encompasses both limited and diffuse systemic sclerosis as well as localized scleroderma, all involving abnormal collagen deposition that stiffens and thickens skin and — in systemic forms — internal organs. The most feared complications are pulmonary fibrosis and pulmonary arterial hypertension.
What's actually going on in research
The field is moving toward earlier and more aggressive treatment in patients with diffuse disease identified by high-risk autoantibodies. Trials are testing combination approaches pairing antifibrotic drugs with immunosuppressives rather than single-agent therapy. B-cell depletion with rituximab and newer anti-BAFF drugs are being tested across skin and lung manifestations. Stem cell transplantation for carefully selected severe early-diffuse disease continues to show long-term benefit in follow-up studies.
Early aggressive treatment
High-risk patients with anti-Scl70 antibodies and rapidly progressive skin thickening are being enrolled in trials of early combination immunosuppressive and antifibrotic therapy.
B-cell targeted therapy
Rituximab depletes B-cells driving autoimmunity and fibrosis in scleroderma. Trials are testing it alongside antifibrotic drugs and evaluating belimumab and other anti-BAFF strategies.
Anti-TGF-beta strategies
TGF-beta is the key driver of fibrosis in scleroderma; drugs targeting TGF-beta signaling — including monoclonal antibodies — are in mid-stage trials for skin and lung fibrosis.
What to know before you search
Eligibility requires confirmed systemic sclerosis, subtype classification (limited vs. diffuse), specific autoantibodies, disease duration, and organ involvement assessment.
What types of trials are currently open
- Immunosuppression trials — Testing mycophenolate, cyclophosphamide, rituximab, and tocilizumab for skin and organ fibrosis.
- Anti-fibrotic trials — Evaluating nintedanib, pirfenidone, and novel TGF-beta pathway blockers.
- Combination therapy trials — Testing paired immunosuppressive and antifibrotic approaches for greater disease control.
- Lung transplant trials — Evaluating outcomes and patient selection for lung transplantation in end-stage scleroderma lung disease.
- Vascular trials — Testing treatments for Raynaud's phenomenon, digital ulcers, and pulmonary arterial hypertension.
Recently added Scleroderma 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 .
Find Scleroderma trials matched specifically to you
Answer 3 quick questions and we'll show you trials that fit your situation.