Phase 2 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:

• Adults aged 18 to under 75 years (the minimum age may vary slightly depending on local rules about what counts as adulthood)
• People who have been formally diagnosed with Systemic Lupus Erythematosus (SLE — a chronic immune system disease) at least 24 weeks before the screening visit, based on recognised international classification standards
• People whose blood tests at screening show at least one of the following: a positive ANA result at a level of 1:80 or higher, or a positive anti-dsDNA antibody, or a positive anti-Smith antibody
• People whose SLE disease activity scores at screening meet specific thresholds on two medical rating scales (SLEDAI-2K total score of 6 or more, and clinical score of 4 or more)
• People whose disease activity at screening reaches at least a certain level on another rating scale (BILAG), as confirmed by both the investigator and an independent reviewer
• People who have been on a stable SLE treatment plan for a set period before screening — this may include up to one immunosuppressant medication and/or one antimalarial medication, and/or a low-to-moderate dose of oral corticosteroids (steroid tablets at no more than 30 mg per day of prednisone or equivalent)
• Additional inclusion criteria apply (confirm with trial site)

Who may not be able to join:

• People whose lupus was caused by a medication (known as drug-induced lupus)
• People who have scleroderma (a connective tissue condition) or other connective tissue diseases that, in the investigator's view, would affect how SLE is assessed or how test results are interpreted — a limited form of scleroderma that does not interfere with assessments may be considered separately (confirm with trial site)
• People with active or unstable lupus affecting the nervous system or mental health, including conditions that reach a certain severity level on the BILAG neuropsychiatric scale — some specific nerve conditions may be exceptions (confirm with trial site)
• People with lupus nephritis (lupus affecting the kidneys) that may need a change in immune-modifying treatment, or where certain kidney function or urine protein measurements are unstable or above specified limits
• People taking oral corticosteroid tablets (such as prednisone) at a dose above 30 mg per day at the time of screening
• Additional exclusion criteria apply (confirm with trial site)

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