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 fully understood the study and voluntarily signed a consent form agreeing to take part.
• You are aged 18 to 75 years old (male or female).
• You were diagnosed with Systemic Lupus Erythematosus (SLE/Lupus) at least 6 months before signing the consent form, and your diagnosis meets at least 4 out of 11 specific medical criteria for lupus.
• Your lupus disease activity score (called SLEDAI-2K) is 8 or higher at the screening visit, meaning your lupus is currently moderately to highly active.
• You have been taking stable lupus treatment — such as steroids, anti-malarial drugs, or immune-suppressing medicines — for at least 30 days before your first study dose.
• A blood test shows that certain lupus-related antibodies (anti-dsDNA, ANA, or anti-Smith) are present in your blood at the screening visit.
• If you are a woman who could become pregnant, you must use two forms of contraception (one being a barrier method) during the trial and for 90 days after your last dose.

Who may not be able to join:

• Women who are pregnant or breastfeeding, or anyone (male or female) who plans to have a child within the next 12 months.
• You have experienced lupus affecting your brain or nervous system (such as seizures, psychosis, stroke, or related conditions) within the 6 months before your first dose.
• You have severe lupus affecting your kidneys, or have needed dialysis or high-dose steroids within the 90 days before your first dose.
• You have been diagnosed with another autoimmune disease in addition to lupus (except for a condition called secondary Sjögren's syndrome, which is allowed).
• You have taken steroid tablets or injections for a non-lupus condition for more than 2 weeks in total during the past 24 weeks before signing the consent form.
• You have a history of, or currently have, a disease affecting the brain or central nervous system (unrelated to lupus).
• You have a heart or cardiovascular condition that is unstable or not well controlled by treatment.
• You have a significant ongoing lung disease, such as scarring of the lungs or chronic obstructive lung disease.
• You have severe disease affecting your liver or bile ducts.
• You have a history of cancer.
• You have had a major organ transplant or a bone marrow/stem cell transplant in the past.
• You have a known allergy to any ingredient in the study drug.
• You have received certain B-cell depleting treatments (such as rituximab or epratuzumab) within the 12 months before joining the study.
• You have received certain chemotherapy drugs (cyclophosphamide or chlorambucil) within the 6 months before joining the study.
• You have received certain biological medicines — including belimumab, TNF blockers, or interleukin blockers — within 3 months before joining the study (or longer, depending on the specific medicine).
• You have tested positive for HIV.
• You have tested positive for Hepatitis B surface antigen, Hepatitis C antibodies, or certain Hepatitis B virus markers in your blood.
• Your blood test results at screening show abnormal levels of certain blood cells or poor kidney function that fall outside the levels required for the study (confirm with trial site).
• The study doctor believes there is any other reason that participating in this trial would not be suitable for you.

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