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:

• People aged 18 to 65 years old at the time of screening (both men and women)
• People with a body mass index (BMI) of 18 or higher at the time of screening (BMI is a measure based on height and weight)
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) for at least 6 months before screening
• People whose blood tests show certain markers of lupus activity (such as ANA at 1:80 or higher, or elevated anti-dsDNA or anti-Sm antibodies) as measured by a central laboratory at screening
• People whose lupus is considered highly active both at the screening visit and at the start of the trial
• People who are already taking at least one standard lupus treatment at a stable dose — this includes steroid tablets, antimalarial drugs (such as hydroxychloroquine), or other immune-suppressing medicines
• People who fully understand the trial process, including possible side effects, and are willing to sign a consent form
• People who are able to use reliable contraception from the time of signing the consent form until 12 weeks after the last dose of study medication, and who agree not to donate eggs or sperm during this period (this applies to women who could become pregnant, and to men whose partners could become pregnant)

Who may not be able to join:

• People with severe lupus-related kidney disease or significant kidney damage
• People who had active neurological or psychiatric symptoms caused by lupus in the 6 months before screening
• People who have another autoimmune, inflammatory, or joint condition alongside lupus (such as rheumatoid arthritis, psoriasis, inflammatory bowel disease, or certain forms of vasculitis) that could affect how trial results are interpreted
• People who had a severe or life-threatening antiphospholipid syndrome (a clotting disorder linked to lupus) within the 12 months before screening
• People with a history of a brain condition called progressive multifocal leukoencephalopathy (PML) (confirm with trial site)
• People who have had an organ transplant at any point
• People who have previously received gene therapies such as CAR-T cell therapy or similar treatments
• People who received a type of treatment called anti-CD20 medication (such as rituximab) within 6 months before the start of the trial, or other B-cell or plasma cell depleting treatments within 6 to 12 months before the start of the trial
• People who received certain targeted biological therapies (those targeting BAFF, APRIL, or interferon receptors) within 12 weeks before the start of the trial
• People who received alkylating agents (a type of strong immune-suppressing drug) within 12 weeks before the start of the trial
• People who received any other biological therapy for lupus within 12 weeks before the start of the trial
• People who received certain targeted medicines known as JAK, BTK, or TYK2 inhibitors within 12 weeks before the start of the trial
• People who received corticosteroids by injection (into a joint, muscle, or vein) for lupus within 4 weeks before the start of the trial
• People who received a live or live-attenuated vaccine within 4 weeks before the start of the trial, or who plan to receive one during the trial
• People with a current or past history of cancer (malignant tumour)
• People with other serious or poorly controlled long-term health conditions, including (but not limited to) heart disease, severe kidney disease, severe breathing problems, serious liver or digestive conditions, neurological or mental health conditions, or certain blood or lymphatic system diseases
• People with a history of widespread or severe shingles (herpes zoster), shingles affecting the brain or eyes, shingles that has occurred twice or more within two years, or shingles that had not fully cleared up within 12 weeks before screening
• People with active tuberculosis (TB) or a hidden (latent) TB infection
• People with a history of a primary immune deficiency, removal of the spleen, or other conditions that make them particularly prone to infections
• People with a history of repeated infections that required hospital admission and intravenous antibiotics
• People who needed hospital care or intravenous infection treatment within 8 weeks before the start of the trial, or who needed oral antibiotics or antiviral medicines for an infection within 2 weeks before the start of the trial
• People who test positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV; people who test positive for a hepatitis B DNA marker (HBV-DNA) may also be excluded — the trial site will assess this based on specific blood test results
• Women who are pregnant or breastfeeding
• People with a history of alcohol abuse or illegal drug use within the year before screening
• People known to be allergic or intolerant to any ingredient in the study drug
• People who had major surgery in the 3 months before screening, or who plan to have major surgery during the trial
• People where the trial investigators determine there are other reasons that make participation unsuitable or that could affect the safety or results of the trial

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