Phase 2 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older at the time of signing the consent form
• People who have been diagnosed with systemic sclerosis (SSc) according to the 2013 international classification guidelines, including those with diffuse, limited, or minimal skin involvement
• People whose SSc symptoms (not counting Raynaud's phenomenon) first appeared within the last 7 years before the screening visit
• People with a skin involvement score (Modified Rodnan Skin Score) below 40 (confirm with trial site)
• People who have interstitial lung disease (ILD) with signs of scarring on a high-resolution CT scan taken within 3 months before joining the trial
• People whose lungs are working at 45% or more of the expected normal breathing capacity (FVC)
• People whose lungs are able to transfer oxygen at 30% or more of the expected normal level (DLCO), adjusted for blood count

Who may not be able to join:

• People whose lung scans show significant abnormalities that are unrelated to SSc-ILD, such as TB scarring, sarcoidosis, or a lung mass
• People who have infected skin ulcers or active gangrene at the time of the screening visit
• People who have had a serious kidney crisis related to their scleroderma within the 6 months before screening
• People whose airflow test result (FEV1/FVC ratio) is below 0.65 before using a breathing inhaler
• People who have previously had a stem cell transplant, bone marrow transplant, CAR-T cell therapy, or an organ transplant
• People who have been treated with the medication rituximab within the 6 months before screening
• People who have previously been treated with certain other immune cell-depleting therapies (confirm with trial site for the full list)
• People who have taken certain medications — including tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, IVIG, cyclophosphamide, or any biologic therapy — within the 3 months before screening
• People who have taken part in another clinical trial or used an investigational drug or device within 30 days, or within 5 half-lives of that drug (whichever is longer), before screening
• People with certain abnormal blood or lab results at screening, including reduced kidney function, elevated liver enzymes, low platelet count, low white blood cell or neutrophil count, or abnormal blood clotting results (confirm with trial site for specific thresholds)
• People with another significant medical condition that the trial doctor believes could make participation unsafe, affect cooperation, or interfere with the trial results
• People with a life-threatening illness where life expectancy is less than 12 months, as assessed by the trial doctor
• People with active tuberculosis (TB) or who are considered at high risk of developing TB

Important: Always verify eligibility with the trial site directly before applying.