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:

• People who are between 18 and 74 years old at the time of signing the consent form
• People who are willing and able to sign a written consent form before any study procedures begin
• People who have been formally diagnosed with systemic sclerosis (a connective tissue disease also called scleroderma) according to recognised international criteria, with active disease (either the limited or diffuse form) that was diagnosed no more than 72 months (6 years) ago
• People who have lung involvement (interstitial lung disease) confirmed by a detailed CT scan, with at least 10% of the lungs affected
• People whose skin thickening, measured using a standard scoring tool called the modified Rodnan skin score, falls between 10 and 45 units
• People already taking certain standard medications (mycophenolate mofetil or methotrexate) who have been on a stable dose for at least 8 weeks before the first study visit
• People on other standard treatments, as long as no new treatment has been started or stopped within 8 weeks before the first study visit
• People taking oral steroid tablets (such as prednisone) who have been on a stable dose of no more than 10 mg per day for at least 8 weeks before the baseline visit
• People who are able to become pregnant and who agree to either abstain from sexual activity or use a highly effective form of contraception throughout the study and for at least 3 months after the last dose of study medication

Who may not be able to join:

• People who are not fully able to give informed consent on their own
• People who are pregnant or currently breastfeeding
• People who had major surgery within 8 weeks before the screening visit
• People who have another rheumatic disease such as lupus, rheumatoid arthritis, or mixed connective tissue disease (a diagnosis of secondary Sjögren's syndrome alongside systemic sclerosis is acceptable)
• People with active diverticulitis (inflammation of pouches in the bowel) or severe bowel inflammation
• People with untreated high cholesterol or lipid disorders (re-screening may be possible after at least 8 weeks of treatment for the lipid disorder)
• People who received a live or weakened (attenuated) vaccine within 4 weeks before the planned start of treatment
• People with a known allergy or sensitivity to certain types of antibody-based medicines, or to peanuts or soy products
• People whose liver enzyme levels (AST and ALT) are more than 1.5 times the upper limit of the normal range (re-screening may be possible if levels return to normal)
• People whose bilirubin (a liver-related blood marker) is more than 1.5 times the upper limit of normal
• People whose kidneys are not filtering blood well enough (creatinine clearance below 30 ml/min)
• People with significant high blood pressure in the lungs (pulmonary hypertension)
• People with airway obstruction or other significant lung function problems, as measured by specific breathing tests
• People with serious heart failure classified as NYHA Class III or IV (confirm with trial site)
• People with more than 4 active finger ulcers, or a history of severe finger tissue damage requiring hospitalisation
• People with a significant risk of bleeding, certain blood clotting abnormalities, or a history of a blood clot or stroke-related bleeding within the past year (confirm with trial site for full details)
• People who have had a stroke or heart attack within 6 months before screening
• People who were previously treated with pirfenidone or nintedanib unless at least 6 months have passed since stopping those treatments before joining this study
• People who have had certain procedures or treatments recently, including plasma exchange, immunoglobulin infusions, or specific medicines targeting the immune system such as tocilizumab, B-cell depleting therapies, biologics, tyrosine kinase inhibitors, alkylating agents, thalidomide, antithymocyte globulin, or bone marrow transplant (confirm with trial site for full list and timeframes)
• People who have taken certain other medications recently, including prednisone above 10 mg/day, azathioprine, hydroxychloroquine, colchicine, D-penicillamine, sulfasalazine within 8 weeks before the first visit; cyclophosphamide within 8 weeks; or rituximab within 6 months of the randomisation visit
• People whose background treatment with mycophenolate mofetil or methotrexate has been changing or unstable in the last 8 weeks
• People with chronic liver disease of any severity
• People with a current serious infection, those who needed intravenous antibiotics in the past 4 weeks or oral antibiotics in the past 2 weeks, or those with active or untreated tuberculosis, active hepatitis B or C, active herpes zoster infection in the past 12 months, or HIV infection
• People who test positive for COVID-19 (SARS-CoV-2) by PCR test at the screening visit (a past COVID-19 infection more than 4 weeks before screening, confirmed by a negative PCR test, is not an exclusion)
• People with a current or past cancer diagnosis, except for certain skin cancers (basal cell or squamous cell carcinoma) that have been fully removed or cured, or cervical carcinoma in situ that has been treated
• People with a current or past history of drug or alcohol misuse
• People who are unable to understand or follow the requirements of the study protocol

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