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 18 years of age or older and are willing to sign a consent form to take part.
• You have been diagnosed with systemic lupus erythematosus (SLE), a condition where the immune system attacks the body's own tissues, confirmed by meeting standard medical criteria.
• You have been diagnosed with lupus nephritis (a type of kidney disease caused by lupus), confirmed by a kidney biopsy taken within the last 6 months (or up to 1 year if you are joining due to a flare-up).
• Your lupus kidney disease has not fully responded to standard treatment, or you are experiencing a moderate to severe flare-up.
• Your lupus disease activity score (called SLEDAI-2K) is 10 or higher, meaning your lupus is currently quite active (confirm with trial site).
• If you are a woman who could become pregnant, you must be using an effective form of birth control during the trial.
• You have received vaccines against pneumonia and flu as part of standard vaccination programmes.

Who may not be able to join:

• You have been taking corticosteroids (steroid medicines) or mycophenolate at doses higher than those allowed under specific Spanish medical guidelines (confirm with trial site).
• You have received certain biologic medicines targeting immune cells, such as rituximab, belimumab, or ocrelizumab, in the 6 months before joining.
• You have been treated with cyclophosphamide (a strong immune-suppressing medicine) in the 6 months before joining.
• You have used medicines called TNF inhibitors (a type of immune-suppressing drug) in the 6 months before joining.
• You have received intravenous immunoglobulin therapy in the 6 months before joining.
• Your dose of certain blood pressure medicines (ACE inhibitors or angiotensin receptor blockers) has been changed in the 2 months before joining.
• You have taken part in another clinical trial or taken an experimental medicine within 3 months before joining (or within a specific time based on the medicine used).
• You have another serious uncontrolled health condition that the trial doctors feel makes participation unsafe or could affect the trial results.
• You have had a heart attack, stroke, or serious blood vessel event in the 6 months before joining.
• You have an active heart rhythm problem or a significant abnormality on a heart tracing (ECG) that the doctors consider unsafe.
• You have had a blood clot in the 12 months before joining, or your blood-thinning treatment is not at the right level.
• You have severe or worsening lupus affecting your brain or nervous system, such as recent uncontrolled seizures or significant memory/thinking problems.
• You have a history of, or currently have, a nerve-damaging condition such as multiple sclerosis or optic neuritis.
• You have another condition, such as asthma or inflammatory bowel disease, that requires you to take steroid medicines regularly.
• You have had an organ transplant in the past or have one planned.
• You currently have a significant infection, have recently been hospitalised for an infection, or have a history of getting the same type of infection three or more times in a 12-month period (minor infections such as oral or genital herpes, vaginal thrush, or nail fungus would not necessarily exclude you — confirm with trial site).
• You have tested positive for HIV, hepatitis B, or hepatitis C.
• You have active or latent tuberculosis (TB), unless you have already completed or are well into an adequate course of TB treatment.
• You have severe, uncontrolled heart failure.
• You currently have active cancer.
• You have had major surgery within 6 weeks before joining, or have major surgery planned during the trial period.
• You are pregnant or breastfeeding.
• You have significant abnormal blood or lab test results that are not explained by your lupus.
• A recent chest X-ray shows signs of active tuberculosis.
• You have been legally declared unable to make decisions for yourself.

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