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 who are able to understand the study requirements, are willing to take part voluntarily, and have signed the consent form before any study procedures begin.
• People aged 18 to 74 years old at the time of screening, of any gender.
• People whose blood tests show certain antibodies linked to lupus (ANA antibody and/or anti-dsDNA antibody).
• People who have had a kidney biopsy within the past 12 months confirming a specific type of active lupus kidney disease (classified as type III or IV, with or without type V, based on a 2003 international classification system).
• People whose lupus kidney disease is currently active, shown by a high level of protein in the urine at both screening and before the start of treatment, and a lupus disease activity score of 8 or above, where the treating doctor has determined that treatment with steroids combined with a drug called MMF is needed.
• People experiencing either their first episode or a return (recurrence) of lupus kidney disease (people who have previously used MMF and had a recurrence may be considered after a joint review by the doctor and study sponsor).
• Women who are able to become pregnant must have a negative pregnancy test at screening, agree not to try to become pregnant or donate eggs from the time of signing the consent form until at least 30 days after the last dose of the study drug, and must use effective contraception during this time. Men must agree not to donate sperm and must use highly effective contraception with female partners from signing the consent form until at least 90 days after the last dose.

Who may not be able to join:

• People whose lupus kidney disease previously did not respond to treatment with MMF or similar drugs, as determined by the treating doctor.
• People who have a known allergy to the study drug or to MMF, or for whom MMF or steroids are medically unsuitable.
• People who are currently taking, or who would need to take during the study, any medication listed as prohibited by the trial.
• People who are already taking steroid tablets at screening for a reason other than lupus, at a dose higher than the equivalent of 10 mg per day of prednisone.
• People who have taken another experimental (investigational) drug within 30 days before screening, or within 5 half-lives of that drug, whichever period is longer.
• People whose kidneys are losing function very rapidly at screening, or whose kidney biopsy shows specific patterns of severe damage (confirm with trial site for exact thresholds).
• People who have severe lupus complications affecting other organs at screening, such as severe high blood pressure in the lungs, severe lung scarring, severe heart muscle inflammation, severe heart failure, or active lupus affecting the brain or nervous system.
• People who have had serious, unstable, or uncontrolled disease affecting major body systems (such as the heart, lungs, blood, digestive system, liver, kidneys, or nervous system) in the six months before screening or at screening, where the cause is not lupus.
• People with a history of another autoimmune disease.
• People with a history of certain serious infections, including: a bacterial infection of a specific type (such as meningococcal, pneumococcal, or Haemophilus influenzae infection) within the past year; active tuberculosis now or within the past two years; a past tuberculosis infection considered at risk of becoming active again; or a positive tuberculosis blood test indicating latent tuberculosis that requires preventive treatment; or any other active infection requiring antibiotic or antimicrobial treatment within the past three months.
• People who have had a major organ transplant (heart, lung, kidney, or liver) or a bone marrow or stem cell transplant, or who are planning to have one.
• People who are currently on regular kidney dialysis or who are expected to need dialysis during the study.
• People who have had stomach or bowel surgery that could significantly affect how the body absorbs medication, or who have severe digestive disease, difficulty swallowing, or frequent vomiting that makes eating or taking tablets difficult.
• People diagnosed with cancer in the past five years, with the exception of certain low-risk skin cancers, a specific type of thyroid cancer, or cervical cancer at a very early (non-invasive) stage.
• People who have had major surgery within the six months before screening.
• People whose blood test results at screening fall outside acceptable ranges, including: kidney filtration rate below a certain level; low counts of certain blood cells (white blood cells, neutrophils, red blood cells, or platelets); liver enzyme or bilirubin levels that are too high; positive test results for hepatitis B (in certain patterns), hepatitis C, or HIV.
• Women who are pregnant or breastfeeding at the time of screening.
• People whom the treating doctor considers unsuitable for the trial for any other reason.

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