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:

• You are between 18 and 75 years old (inclusive)
• You have been diagnosed with systemic lupus erythematosus (lupus) based on recognised medical guidelines
• You have an active form of lupus that affects the kidneys (called lupus nephritis), confirmed by a kidney biopsy taken within the past year or during the screening period
• Your blood tests show certain markers of lupus activity (specific antibodies called ANA and/or anti-dsDNA)
• Your kidney disease is currently active and requires strong treatment with high-dose steroids combined with a medicine called mycophenolate
• This steroid and mycophenolate treatment must have been started within 60 days before or on the first day of the trial
• You are able to understand what the study involves and are willing to sign a consent form

Who may not be able to join:

• You have a known allergy or medical reason why you cannot take the planned study medicines (such as mycophenolate or steroids)
• You have a history of allergic reactions to contrast dyes, or to medicines made from human or animal proteins (including certain antibody-based treatments)
• You have previously received a B-cell targeted therapy (such as rituximab), unless your B-cell levels have returned to normal
• You have received certain immune-suppressing or biologic medicines (including Belimumab) within the past 12 weeks (or longer, depending on the specific medicine)
• You have taken an experimental drug within the past 12 weeks (or longer, depending on the specific drug)
• You have undergone plasma separation or plasma exchange treatment within the past 6 weeks
• You needed dialysis at any point in the year before screening
• You have received a live vaccine within the past 4 weeks, or are expected to receive one during the study
• You received a BCG vaccine within the past year
• You have had a severe lupus-related brain or nervous system problem (such as seizures, stroke, or psychosis) requiring treatment within 60 days before starting the trial
• You have had a major organ transplant (such as heart, lung, kidney, or liver) or a stem cell/bone marrow transplant, or are due to have one
• You have a significant, unstable, or uncontrolled serious illness unrelated to lupus (such as heart, lung, liver, or kidney disease, cancer, or serious infection) that the doctor feels could affect the study or put you at risk
• You are planning surgery, or have a medical condition or abnormal test result that the doctor feels makes you unsuitable for the study
• You have had a problem with drug or alcohol misuse or dependence in the past year
• You are pregnant, breastfeeding, or you or your partner are planning to become pregnant during the study
• You have had a cancer diagnosis in the last 5 years (except for certain treated skin cancers or early-stage cervical changes)
• You currently have an infection (acute or ongoing) that requires treatment
• You are HIV positive
• You have active hepatitis B (confirm with trial site for specific details about borderline hepatitis B results)
• You have tested positive for hepatitis C antibodies
• You have had COVID-19 within the past 4 weeks, or were hospitalised with severe COVID-19 within the past 12 months
• Your kidney function is significantly reduced, measured by a specific blood test (eGFR below 30 mL/min/1.73m²)
• Your kidney biopsy showed that 50% or more of the kidney filtering units are permanently scarred
• You have significantly abnormal blood or lab test results at a level considered serious (Grade 3 or higher)
• The study doctor feels for any other reason that you are not suitable to take part

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