Phase 4 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 who have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) according to standard medical criteria.
• People whose SLE diagnosis was made within the last 2 years before the screening visit.
• People whose blood tests show a positive ANA result at a level of 80 or higher.
• People whose blood tests show a positive anti-double-stranded DNA antibody result.
• People with mild to moderate lupus disease activity, based on a standard scoring tool called the SLEDAI-2K (score of 4 or above).
• People who have been on a stable dose of corticosteroids (steroid medication) of no more than 30mg per day for at least 4 weeks before screening.
• People taking methotrexate, provided the dose has been stable for at least 4 weeks.
• People who are also being treated with hydroxychloroquine, unless there is a documented medical reason they cannot tolerate it.
• People who are able and willing to sign a consent form and follow the study requirements.
• Women who could become pregnant must have a negative blood pregnancy test at screening.
• Men and women of reproductive age who agree to use an acceptable form of contraception during the treatment period and for 16 weeks after treatment ends.

Who may not be able to join:

• People who have previously used certain immune-modifying medications such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine.
• People who have previously been treated with biologic therapies such as rituximab, belimumab, or similar medicines studied for lupus.
• People with active kidney disease or nervous system involvement from lupus, or whose lupus activity meets a high-severity threshold on a standard medical scale called BILAG A.
• People who have used high-dose steroids (above a certain daily weight-based dose) within the 4 weeks before screening.
• People where the treating doctor expects that additional immune-modifying medication will be needed within the first 52 weeks of the study.
• People with a haemoglobin (red blood cell level) below 8.0 g/dL on blood tests.
• People with a platelet count (cells that help blood clot) below 50,000/mm³ on blood tests.
• People with a low neutrophil count (a type of white blood cell) below a specified level on blood tests.
• People with significantly elevated liver enzyme levels (AST or ALT more than 2.5 times the upper limit of normal), unless this is caused by lupus itself.
• People with significantly reduced kidney function based on a calculated kidney filtration rate (confirm with trial site).
• People who test positive for Hepatitis B or Hepatitis C on blood tests.
• People with a known history of HIV, or who test positive for HIV during screening.
• People who have taken part in another clinical trial or used an experimental medicine within 4 weeks of screening, or within 5 half-lives of that experimental drug, whichever is longer.
• People who have received a live vaccine within 30 days before the start of the study, or at the same time as the study drug belimumab.
• People with a history of a severe allergic reaction to contrast dyes, human or animal-derived proteins, or monoclonal antibody treatments.
• People currently taking long-term medication to suppress or manage a chronic infection such as tuberculosis, CMV, herpes, or related conditions.
• People who were hospitalised for an infection within 60 days before the study start date.
• People who received intravenous or injected antibiotic, antiviral, antifungal, or antiparasitic treatment within 60 days before the study start date.
• People with a history of serious, recurring, or long-term infections.
• People without adequate vein access for intravenous treatment.
• People with a history of drug, alcohol, or chemical misuse within the 12 months before the study start date.
• Women who are pregnant (ongoing pregnancy testing is required throughout the study).
• Women who are currently breastfeeding.
• People with a history of a psychiatric condition that would prevent them from fully participating in the study.
• People with significant heart or lung disease, including chronic obstructive pulmonary disease.
• People with any other medical condition, test finding, or health concern that, in the treating doctor's judgement, would make participation unsafe or affect the study results.
• People who have had a cancer diagnosis within the last 5 years, with the exception of certain treated skin cancers or early-stage cervical changes.
• People with evidence of serious suicide risk, including suicidal behaviour in the last 6 months, suicidal thoughts in the last 2 months, or where the treating doctor considers the risk to be significant.
• People with a history of a primary immune deficiency condition.
• People with a significantly low IgG antibody level (below 400 mg/dL) on blood tests.
• People with a significantly low IgA antibody level (below 10 mg/dL) on blood tests.
• People with any other abnormal blood test result considered clinically significant by the treating doctor.
• People who require ongoing corticosteroid treatment for other conditions, including those who have needed two or more courses of systemic steroids for any reason in the past 12 months.
• People who would be unable to comply with the study visits and follow-up requirements.

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