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:

• People who are willing to give written consent and are able to follow the trial plan from start to finish
• People aged 18 to 75 years old (inclusive), of any gender
• People diagnosed with rheumatoid arthritis (RA) based on 2010 ACR/EULAR criteria, or systemic sclerosis (SSc) based on 2013 ACR/EULAR criteria
• People whose interstitial lung disease (ILD) was confirmed by a specific type of chest scan (HRCT) within the 12 months before the screening visit
• People whose lung capacity (FVC) measures at least 40% of the expected value at screening
• People whose lung gas-transfer ability (DLCO, adjusted for haemoglobin) measures at least 40% of the expected value at screening
• People who may be taking one immunosuppressant medicine, as long as the dose has been stable for at least 3 months before the first dose and the person agrees to keep it stable for at least 6 months after the first dose
• People of childbearing potential who do not plan to become pregnant or donate sperm or eggs, and who agree to use reliable contraception throughout the trial and for 6 months after the last dose

Who may not be able to join:

• People with a known allergy to the study drug or to biological medicines, or who have had other serious allergic reactions in the past
• People with airway obstruction (a specific breathing test result below 0.7 before using a bronchodilator), other significant lung abnormalities as judged by the investigator, or a history of asthma
• People who have recently received certain medicines, including: high-dose steroid medicines (prednisone above 15 mg/day or equivalent) within 2 weeks before joining; azathioprine, colchicine, D-penicillamine, or sulfasalazine within 8 weeks before joining; rituximab, tocilizumab, nintedanib, pirfenidone, or similar treatments within 6 months before joining; certain biological medicines (such as TNF inhibitors) within 3 months before joining; or certain other medicines including tofacitinib, tacrolimus, cyclosporine A, or potassium para-aminobenzoate within 30 days or 5 half-lives before screening (whichever is longer)
• People who also have another rheumatic disease such as inflammatory muscle disease, lupus, Sjögren's syndrome, mixed connective tissue disease, or systemic vasculitis
• People with significant pulmonary hypertension (high blood pressure in the lungs), including those with evidence of serious right heart failure, a low heart output measured by a specific heart test, or who require certain intravenous medicines for pulmonary hypertension
• People with active internal bleeding, a serious tendency to bleed (such as haemophilia), or who are currently on blood-thinning (anticoagulant) medicines
• People who have had an infection requiring systemic medicines within 7 days before screening, or who have been diagnosed with active tuberculosis
• People who have received a live or weakened (attenuated) vaccine within 3 months before screening, who plan to receive one during the trial, or who received a COVID-19 vaccine within 2 weeks before screening
• People who have previously had stem cell therapy, bone marrow transplant, or a solid organ transplant, or who have been on long-term systemic steroids for other conditions
• People with a history of serious immune deficiency or other inherited or acquired immune system disorders
• People with a history of a cancerous (malignant) tumour within the 5 years before screening
• People currently receiving kidney dialysis
• People with certain significant heart conditions, including: severe heart failure (NYHA Class IV) or a heart pumping function below 30% on scan; a heart attack, acute coronary event, viral heart inflammation, or blood clot in the lungs within the past 3 months; heart artery procedure within the past 6 months; serious irregular heart rhythms requiring certain medicines or specific electrical conduction problems without a pacemaker; or an abnormal heart electrical reading (QTcF of 480 ms or more) or a history of prolonged QTc interval
• People with certain abnormal blood test results at screening, including: low white blood cell or neutrophil counts; low platelet count; raised liver test results above certain thresholds; or reduced kidney function (eGFR below 60 ml/min/1.73m²)
• People with a current or past positive result for hepatitis B surface antigen, hepatitis B core antibody with detectable virus levels, hepatitis C antibody, HIV antibody, or syphilis antibody requiring treatment
• People who have taken part in another clinical trial involving an experimental drug or medical device within the 3 months before screening
• People who test positive for pregnancy at screening, or who are currently breastfeeding
• People whom the investigator considers unsuitable for any other reason

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