Phase 3 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, also called lupus) based on a specific set of internationally recognised medical guidelines from 2019.
• People who have had a kidney biopsy (a small sample taken from the kidney) within the last 6 months showing a specific type of kidney inflammation linked to lupus (called lupus nephritis Class III, IV, or V), or who are willing to have a biopsy done during the screening period.
• People whose kidneys are currently showing signs of active disease, measured by a specific protein-to-creatinine ratio in urine collected over 24 hours (confirm with trial site for exact values).
• People whose kidneys are still functioning above a certain minimum level, measured by a test called eGFR of at least 15 mL/min/1.73 m² — though people with lower kidney function within this range may need to meet additional biopsy-based requirements (confirm with trial site).
• People who have started, or are starting, a specific combination of background treatments, including a medicine called mycophenolate (taken by mouth daily) and corticosteroids (given either by injection into a vein and/or as daily oral tablets), following the dosing plan set out by the trial.
• People who are already taking certain other lupus medicines (such as antimalarials or belimumab) may also be eligible, provided those medicines were started at least 4 weeks before screening and the dose has remained stable — the trial site can confirm the details.
• People who are capable of becoming pregnant and who agree to use a highly effective form of contraception from the start of screening until at least 24 weeks after the trial treatment ends, and who agree to monthly pregnancy tests during that same period.

Who may not be able to join:

• People who currently have severe, active lupus affecting the brain or central nervous system.
• People who have, or have had, other kidney diseases (apart from lupus nephritis) that could affect kidney assessments, or who currently need dialysis or have had a kidney transplant, or who have end-stage kidney failure.
• People who have a history of, or currently have, certain heart rhythm problems, including specific types of heart block, sick sinus syndrome, an unusually slow heart rate with symptoms, or fainting caused by heart conditions.
• People who, in the 6 months before screening, have experienced a heart attack, unstable chest pain (angina), stroke, mini-stroke (TIA), blood clots in blood vessels, severe heart failure requiring hospitalisation, or significant heart failure affecting daily activities.
• People whose resting heart rate, as measured by a heart tracing (ECG) at screening or before starting the trial, is below 50 beats per minute.
• People who have been diagnosed with active or latent (dormant) tuberculosis at screening or within the 6 months before screening.
• People who test negative for immunity to the chickenpox virus (varicella-zoster).
• People whose blood tests show signs of active or ongoing infection with hepatitis A, B, C, or E.
• People who test positive for HIV, or who have any other condition — present from birth or developed later — that weakens the immune system.
• People who have certain eye conditions found during an eye examination at screening, including fluid build-up in the central part of the eye (macular oedema), degeneration of the central vision area (foveal degeneration), active eye inflammation (uveitis), swelling of the optic nerve (papilledema), or abnormal new blood vessel growth in the eye.
• People whose blood test results at screening show significantly abnormal levels, including very low red blood cell count (haemoglobin below 7 g/dL), very low lymphocyte count, very low white blood cell count, or very low platelet count (confirm exact thresholds with trial site).
• People who have recently taken certain immune-suppressing medicines — including cyclosporine, voclosporin, tacrolimus, sirolimus, or cyclophosphamide — within a specific timeframe before starting the trial (confirm with trial site).
• People who have taken leflunomide, intravenous immunoglobulins, methotrexate, or certain targeted medicines called tyrosine kinase inhibitors within 90 days before starting the trial.
• People who have received a medicine called anifrolumab within 6 months before starting the trial.
• People who have received certain biological immune-suppressing medicines (such as anti-TNF, anti-IL-1, or anti-IL-6 treatments) within 90 days before starting the trial.
• People who have received B cell-depleting medicines (such as rituximab, obinutuzumab, or ocrelizumab) within 12 months before starting the trial.
• People who have ever received alemtuzumab, or medicines in a class called sphingosine-1-phosphate receptor modulators (such as fingolimod), at any point in the past.
• People who have previously taken part in any clinical trial involving the study drug cenerimod (as either the active medicine or a placebo).
• People who are pregnant, planning to become pregnant, or currently breastfeeding.

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