Systemic Sclerosis Clinical Trials and Treatments

Systemic sclerosis combines three problems in one disease: an overactive immune system, damage to small blood vessels, and runaway production of collagen that scars (fibroses) skin and internal organs. Nearly every patient has Raynaud phenomenon, often years before anything else, and most develop skin thickening that typically begins in the fingers. Doctors divide the disease into two main forms.

The most common symptoms of Systemic Sclerosis include Fingers that turn white or blue in cold or stress (Raynaud phenomenon), Thickening and tightening of the skin, usually starting in the fingers, Heartburn, reflux, or difficulty swallowing, Shortness of breath or a dry cough from lung scarring, Painful sores or ulcers on the fingertips, among others. About 276 per million U.S. adults in a large Detroit-area study; about 19 new cases per million adults each year. Symptoms can range from mild to severe and may vary between individuals.

Trial Friend lists all active clinical trials for Systemic Sclerosis from ClinicalTrials.gov, with eligibility criteria translated into plain English. Patients can filter by trial phase and recruitment status, search by location, and use the Match Me tool to score trials against their profile. Two drugs are FDA approved for the lung complication of systemic sclerosis: nintedanib (Ofev, approved 2019) and tocilizumab (Actemra, approved 2021), both shown to slow the decline of lung function in scleroderma-related interstitial lung disease. No drug is yet approved for the underlying disease itself, so rheumatologists rely on off-label immunosuppressants such as mycophenolate, and stem cell transplant has shown durable benefit in carefully selected patients with severe, rapidly progressive disease.

Yes. As of October 21, 2026, 2 FDA-approved medicines have a current label that names Systemic Sclerosis: Actemra (tocilizumab), first approved in 2010; and Ofev (nintedanib), first approved in 2014. Corticosteroids and immune globulins count once each.

The exact cause of Systemic Sclerosis is not fully understood. It is not caused by a single gene; inherited variants raise risk, and immune, environmental or other triggers are thought to set it off. HLA, IRF5 and STAT4 variants shift risk; most cases are sporadic and no diagnostic gene test exists. About 276 per million U.S. adults in a large Detroit-area study; about 19 new cases per million adults each year. Research is ongoing to better understand the disease mechanism.

No single gene test diagnoses Systemic Sclerosis. The diagnosis rests on clinical findings and laboratory or imaging results; genetic variants shift risk rather than cause the disease. HLA, IRF5 and STAT4 variants shift risk; most cases are sporadic and no diagnostic gene test exists.

Some trials collect genetic samples for research or check specific risk markers. The Genetic Testing section of this page shows any tests listed in the NIH Genetic Testing Registry, which for this condition are usually research or risk-marker tests rather than diagnostic ones.

Eligibility for Systemic Sclerosis clinical trials depends on factors like age, diagnosis, treatment history, and overall health. Each trial sets its own inclusion and exclusion criteria. Trial Friend translates these requirements from medical language into plain English so patients can review them more easily. The Match Me tool can score your profile against active trials to help identify studies that may be a fit.

Participating in a Systemic Sclerosis clinical trial typically involves scheduled visits, medical tests, and close monitoring by a research team. Depending on the study phase, you may receive an investigational treatment, a placebo, or the current standard of care. Trials may last from a few weeks to several years. Study participation is voluntary, and you can withdraw at any time.