Phase 3 Lupus Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 14–17 years old (children/teenagers) or adults
- People with active lupus nephritis (lupus affecting the kidneys) confirmed by a kidney biopsy taken within the past 8 weeks, showing a specific level of kidney inflammation as classified by an international kidney disease system (class III or IV, or class V with active involvement in at least 10% of the examined kidney tissue)
- People whose urine protein test result meets a minimum threshold (a urine protein-to-creatinine ratio of 0.5 g/g or higher) at any point in the 14 days before joining
- People who have no medical reasons preventing them from receiving the study treatments: IV methylprednisolone (a steroid given by drip), MMF (mycophenolate mofetil, an immune-suppressing tablet), oral corticosteroids (steroid tablets), or obinutuzumab (a targeted therapy)
- People who are able to give informed consent to participate
- People who are willing to use appropriate contraception as recommended when taking MMF
Who may not be able to join:
- People experiencing a severe lupus flare that, in the treating doctor's opinion, requires stronger immune-suppressing treatment than what the trial allows
- People who, in the treating doctor's opinion, cannot be managed with only a low dose (10 mg prednisone) of corticosteroids after joining the trial
- People who are pregnant or breastfeeding
- People who have received certain targeted biological therapies (monoclonal antibodies, or B-cell or T-cell modifying biologics) within the 6 months before joining — except belimumab, which is permitted if stopped at least 7 days before enrolment
- People whose kidney biopsy shows that more than 60% of the kidney filtering units (glomeruli) are permanently scarred, or that more than 60% of the surrounding kidney tissue is scarred
- People with advanced chronic kidney disease, specifically stage 4 or 5, meaning kidney filtering function is below a certain level (eGFR under 30 ml/min/1.73m²) — this does not apply to sudden, short-term kidney injury (confirm with trial site)
- People with active infections, including HIV, untreated hepatitis B, hepatitis C, or tuberculosis
- People who received a live-attenuated vaccine (a type of vaccine using a weakened live virus) within the 4 weeks before joining the trial
- Female patients who have had a history of certain cervical cell changes or high-risk HPV in the past 3 years — however, this exclusion may not apply if a follow-up HPV test came back negative, or if the cervical abnormality was successfully treated more than one year ago (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Nathalie COSTEDOAT-CHALUMEAU, MD, PhD, Centre de référence maladies auto-immunes et systémiques rares, Internal medicine, Cochin hospital, APHP
Phone: +33 (0)6 87 50 81 23
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Complete renal response (CR); Proteinuria measurement; Proteinuria measurement
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.