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 aged 18 to 75 years old who are able to give written consent before any study procedures begin.
• People who have previously been diagnosed with systemic lupus erythematosus (SLE) — a condition where the immune system attacks the body's own tissues — based on established medical criteria.
• People who have active lupus nephritis (kidney inflammation caused by lupus), confirmed by a kidney biopsy taken within the past 2 years showing a specific type of damage (Class III, IV, or V), along with specific levels of protein in the urine at the time of screening.
• People whose biopsy was done more than 6 months before screening must also show that their urine protein levels have at least doubled in the 6 months before screening.
• People who, in their doctor's judgment, need high-dose steroids and medicines that calm the immune system.
• People who are willing to take a medicine called MMF (mycophenolate mofetil) by mouth throughout the entire study, either by continuing it or starting it before the study begins.
• People who are able to use reliable contraception with their partner from the time they sign consent until 3 months after the trial ends; women who could become pregnant must have a negative pregnancy test at both screening and the baseline visit.

Who may not be able to join:

• People whose kidneys are not functioning well enough, based on a standard kidney function calculation (eGFR of 45 or below) at screening.
• People who are currently taking, or plan to take, certain medicines that are not allowed during the trial, or who have not completed the required washout period before joining.
• People who are currently on kidney dialysis, or who are expected to need dialysis during the study.
• People who have had a kidney transplant in the past, or who are planning one during the study period.
• People who are known to have an allergy or medical reason to avoid any of the medicines planned for use in the study, including MMF, Mycophenolate Sodium, Cyclosporine, Voclosporin, or corticosteroids (confirm with trial site).
• People with a history of drug or alcohol misuse within the past 2 years.
• People who have had cancer within the past 5 years, with some exceptions for certain treated skin cancers and treated cervical conditions that have been confirmed as resolved.
• People with a history of a disease affecting the lymph system, or who have had total lymphoid irradiation (a type of radiation treatment).
• People who have had a serious viral infection — such as cytomegalovirus, hepatitis B, or hepatitis C — within the past 3 months, or who have a known HIV infection.
• People with active tuberculosis (TB), or a known history of TB or signs of old TB infection, unless they are already taking a preventive antibiotic called isoniazid.
• People with serious heart conditions, including heart failure, certain heart rhythm problems, a condition called long QT syndrome, or high blood pressure that remains poorly controlled despite taking two or more blood pressure medicines.
• People whose heart's electrical activity shows a specific abnormality (a prolonged QT interval) on a heart tracing at screening.
• People with liver problems, shown by certain blood test levels being 2.5 times or more above the normal range at screening, unless those levels return to an acceptable range before the study begins.
• People with chronic lung disease or asthma that requires ongoing treatment with steroid tablets.
• People with low blood cell counts — including low white blood cells, low neutrophils (a type of white blood cell), or low platelets — that are not related to their SLE.
• People who, in their doctor's assessment, have active bleeding.
• People who have an active infection currently requiring intravenous (drip) antibiotic, antiviral, antifungal, or antiparasitic treatment during the screening period.
• People who have another immune system condition (besides SLE and lupus nephritis) where either the condition itself or its treatment could affect the study results or safety (confirm with trial site for specific overlapping conditions).
• People who have received a live or weakened live vaccine within 4 weeks before screening, or who would need one during the study.
• People who, in their doctor's judgment, have had significant, unstable, or poorly managed physical or mental health conditions or injuries in the 6 months before screening that could affect the trial.
• Women who are pregnant or breastfeeding.
• People who have taken part in another medicine or device trial within 4 weeks before screening, or within 5 half-lives of that study drug — whichever period is longer.
• People who were previously enrolled in a clinical trial of Voclosporin and received that study drug.
• People where, in the investigators' judgment, there are conditions that may affect the trial results, or where the risks of taking part outweigh the potential benefits.

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