Phase 4 Lupus 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 have been diagnosed with systemic lupus erythematosus (a type of autoimmune disease) according to recognised 2019 international classification standards
• Men or women who are not pregnant, aged 18 or older
• People who have been diagnosed with interstitial lung disease (scarring or inflammation in the lungs) confirmed by a specialised type of lung CT scan
• People whose lung function test results meet certain minimum thresholds for airflow and the lungs' ability to transfer oxygen into the blood (confirm with trial site for specific values)
• People who are willing to take part, are able to attend follow-up appointments, and are able to understand and sign a consent form before the study begins

Who may not be able to join:

• People whose liver enzyme levels (ALT and/or AST) are more than 5 times the upper limit of the normal range
• People with severe chronic kidney disease (stage IV) or who need dialysis, or whose kidney filtration rate is below a certain level
• People with a very low red blood cell count (haemoglobin below 80 g/L)
• People with a very low white blood cell count
• People with a very low platelet count (platelets help blood to clot)
• People who are pregnant or breastfeeding
• People who are likely to be transferred to a hospital outside the study network within 4 weeks, making follow-up difficult
• People whose life expectancy is estimated at less than 24 weeks
• People with a history of severe allergic reactions
• People with other serious lung diseases or other significant lung abnormalities
• People currently using anti-cancer drugs, other immune-suppressing medications, or immune-modifying therapies
• People with significant high blood pressure in the blood vessels of the lungs (pulmonary hypertension)
• People with a history of significant right-side heart failure, confirmed by clinical assessment or heart scan, including specific measurements from a heart catheter procedure, or people who need a particular medication (epoprostenol/traprostacyclin) to treat pulmonary hypertension
• People who have had a heart attack or unstable chest pain within the past 6 months
• People at risk of bleeding, including those with a known inherited tendency to bleed, or those who require full-dose blood-thinning therapy or high-dose antiplatelet (anti-clotting) medication (note: low-dose preventive use of certain medications may be permitted — confirm with trial site)
• People who have had a bleeding event in the brain within the past 12 months
• People who have had coughing up blood, blood in the urine, active gastrointestinal bleeding, or stomach ulcers within the past 3 months
• People who have previously had a stem cell transplant, or who plan to have one in the coming year, or who plan to have major surgery
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• Women of childbearing age who are unwilling or unable to use highly effective contraception from 28 days before starting the study medication until 3 months after finishing it
• People the investigator considers to have problems with alcohol or drug misuse
• People with difficulty swallowing or a gastrointestinal condition that could affect how medication is absorbed
• People for whom the study drug (telitacicept) is medically unsuitable
• People the investigator considers unsuitable for the study for any other reason

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