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
• You have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) for at least 12 weeks before the screening visit
• Your lupus is considered moderately to severely active, based on a standard scoring system used by doctors
• A blood test within the last 12 months or at screening shows certain markers linked to lupus (specific antibodies or immune proteins)
• You are currently taking at least one standard lupus treatment (such as steroids, antimalarial drugs, or immune-suppressing medication) at a steady, unchanged dose for at least 4 weeks
• You agree to use reliable contraception with your partner from signing the consent form until 6 months after your last dose of the study drug (applies to all men and women who could become pregnant)
• You understand what the study involves and are willing to sign a consent form voluntarily

Who may not be able to join:

• You have severe or unstable lupus affecting the brain or mental health
• You have another autoimmune disease that could affect how the trial results are measured
• You have a serious condition called catastrophic antiphospholipid syndrome (a rare blood-clotting disorder) (confirm with trial site)
• You have received a live or weakened (attenuated) vaccine within 28 days before the study begins
• You have a significant risk of bleeding
• Your liver function blood tests are too abnormal (levels of certain liver enzymes or bilirubin are too high)
• Your blood cell counts are too low — including white blood cells, platelets, or red blood cells
• Your kidneys are not functioning well enough (based on a measure called eGFR being below 30) (confirm with trial site)
• A pregnancy test comes back positive
• You have taken part in another clinical trial or received an experimental treatment recently (within 30 days or longer, depending on the drug)
• You have a recurring, long-term, or currently active infection
• You have a severe or poorly controlled medical condition that would make it unsafe to participate
• You have tested positive for HIV, hepatitis C (HCV), or hepatitis B (HBV)
• You have active tuberculosis (TB) or a hidden (latent) TB infection
• You have any active infection (other than a fungal nail infection)
• You have a history of a rare brain infection called progressive multifocal leukoencephalopathy (PML)
• You have poorly controlled type 1 or type 2 diabetes
• Your blood pressure is too high and not well controlled (above 140/90 mmHg)
• You have been diagnosed with any type of cancer in the last 5 years
• You have had problems with alcohol or drug misuse in the past 12 months
• You have had a severe allergic reaction to a type of medicine called monoclonal antibodies, or to any ingredient in the study drug
• You have had or are expected to need major surgery around the time of the study
• You have a mental health condition or are unlikely to follow the study requirements
• You have severe lupus that has seriously affected your kidneys
• You have had an organ transplant or bone marrow/stem cell transplant, or are expected to have one during the study
• You are currently pregnant or breastfeeding
• The trial doctor feels there is any other reason you should not take part

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