Who Is Eligible for Scleroderma Trials?
SSc trials typically enroll patients with either diffuse cutaneous SSc (dcSSc) or limited cutaneous SSc (lcSSc), stratified by disease duration and organ involvement. Most trials for fibrosis and skin disease require early diffuse SSc (within 3-5 years of first non-Raynaud symptom) because this is the window of greatest skin and organ progression. Trials for SSc-ILD often have separate eligibility based on pulmonary function testing.
- Confirmed SSc per 2013 ACR/EULAR criteria
- Diffuse cutaneous SSc with skin involvement measured by modified Rodnan Skin Score (mRSS)
- Disease duration from first non-Raynaud symptom โ usually within 5 years for skin trials
- SSc-ILD trials: FVC above a minimum threshold (often 40-45%) with ILD on HRCT
- Some trials enroll lcSSc specifically for pulmonary hypertension-focused studies
What Treatments Are Being Tested?
| Drug Class | How It Works | Who It Is For |
|---|---|---|
| Antifibrotic agents | Block TGF-beta and other fibrotic pathways driving skin thickening and organ fibrosis | Diffuse SSc with active skin thickening, early disease |
| CD20 B cell depletors | Deplete autoreactive B cells contributing to fibrosis and autoimmunity โ rituximab biosimilars and next-gen agents | dcSSc, SSc-ILD |
| IL-6 inhibitors | Block IL-6 signaling involved in fibrosis and vascular damage | Active dcSSc, elevated inflammatory markers |
| CAR-T cell therapy | Immune reset โ early results in severe dcSSc showing skin score improvement | Severe refractory dcSSc |
| Nintedanib combinations | Antifibrotic drug approved for SSc-ILD, now being tested in combination regimens | SSc-ILD with progressive fibrosis |
What to Expect as a Trial Participant
SSc trials measure skin involvement using the modified Rodnan Skin Score (mRSS) and lung function using spirometry and HRCT. Visits are typically every 4-12 weeks. ILD trials often require pulmonary function tests at each visit.
- Screening: mRSS skin assessment, pulmonary function tests, HRCT if ILD suspected, labs, echocardiogram
- Baseline: Randomization โ most skin trials are double-blind
- Treatment visits: Every 4-12 weeks depending on drug
- Pulmonary monitoring: FVC and DLCO testing at regular intervals in ILD trials
- Compensation: Most sites pay $75-$250 per visit
Frequently Asked Questions
Other Rheumatology Trials
Trial data sourced live from ClinicalTrials.gov. Content reviewed by Mahiar Rabie, MS, MD. This page is for informational purposes only and does not constitute medical advice. Eligibility for any specific trial must be confirmed with the trial coordinator.