Phase 3 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:

• You are 18 years old or older at the time of signing the consent form.
• You have been officially diagnosed with systemic sclerosis (SSc) based on recognized medical classification guidelines.
• Your SSc has caused skin thickening in areas above the elbows and/or knees, as well as in the hands or feet, as assessed on the first day of the study.
• Your skin thickening score (a standard measurement called mRSS) is 15 or higher on the first day of the study.
• A lung scan (HRCT) shows signs of lung scarring (interstitial lung disease).
• A blood test at screening shows you do not have a specific antibody called "anticentromere antibody."
• Your disease shows signs of being active or getting worse.
• You have an area of skin on your belly or front of your thigh that is unaffected or only mildly affected, allowing for under-the-skin injections.
• You are able and willing to give yourself the study medication by injection, or you have a caregiver who can do this for you throughout the study.
• If you are a woman, you are not pregnant or breastfeeding, and either cannot become pregnant or are using a highly effective form of contraception.
• You are able to understand and sign the consent form agreeing to take part.

Who may not be able to join:

• You have a condition that looks like systemic sclerosis but is a different diagnosis, such as localized scleroderma, eosinophilic fasciitis, or a scleroderma-like condition caused by certain chemicals or drugs (confirm with trial site).
• Your main diagnosis is another autoimmune or rheumatic disease, such as rheumatoid arthritis, lupus, or Sjögren's syndrome, rather than diffuse systemic sclerosis.
• Your lung function tests show your lungs are severely affected (below certain thresholds), or you already need extra oxygen.
• You have been diagnosed with a type of high blood pressure affecting the lungs (pulmonary arterial hypertension).
• You had a serious kidney complication related to SSc (SSc renal crisis) within the last 6 months.
• You have a significant heart, liver, kidney, or other organ condition that could affect how the study drug works in your body or make it unsafe.
• Your breathing tests show a type of airway blockage called obstructive pulmonary disease.
• Your lung scan shows significant emphysema that is more widespread than the lung scarring.
• You have had, or are planning to have, a major organ transplant (such as heart, lung, kidney, or liver) or a bone marrow/stem cell transplant.
• You have been treated with certain biologic medications (such as monoclonal antibodies or intravenous immunoglobulin) within the past 3 months or longer, depending on the specific drug.
• You have been treated with rituximab (a specific biologic drug) within the past 6 months.
• You have taken certain non-biologic immune-suppressing medications (other than mycophenolate, methotrexate, or azathioprine) within the past 3 months (confirm with trial site for full list).
• You have taken cyclophosphamide (a strong immune-suppressing drug) within the past 6 months.
• You have used certain anti-fibrotic (anti-scarring) medications, such as pirfenidone or nintedanib, within the past 4 weeks.
• You have taken certain strong chemotherapy-type drugs within the past 6 months (confirm with trial site).
• You have received corticosteroid injections into a muscle or vein within the past month.

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