A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorViatris Innovation GmbH
About this trial
The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are:
* Does cenerimod improve kidney function in participants? * What medical problems do participants have when taking cenerimod?
Researchers will compare cenerimod to a placebo (a look-alike substance that contains no drug) to see how well cenerimod works when it is added to regular treatment.
Participants will:
* Take cenerimod or a placebo every day for 76 weeks (approximately 1.5 years), on top of regular treatment. * Visit the clinic every 1 to 3 months for checkups and tests.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Classification of systemic lupus erythematosus (SLE) made according to the 2019 European Alliance of Associations for Rheumatology / American College of Rheumatology (EULAR/ACR) criteria.
Renal biopsy within 6 months prior to Screening visit indicating Class III or IV active glomerulonephritis with or without co-existing Class V, OR pure Class V membranous LN. If no biopsy was performed within 6 months of Screening, a biopsy will be performed during the Screening period, after all other inclusion/
Disqualifiers
Active renal disease defined as urine protein/creatinine ratio ≥ 1 mg/mg, assessed on a 24h urine collection.
a renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli,
activity index ≥ 2, and chronicity index < 4, on the National Institutes for Health 2018 activity and chronicity indices. These indices must be assessed on the kidney biopsy dated less than 6 months prior to Screening and confirmed by a nephropathologist.
Mycophenolate mofetil 1-3 g/day orally or mycophenolate sodium 720-2160 mg/day orally at Randomization. This treatment can be in place before Screening or started at Screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Cenerimod
DrugCenerimod will be supplied as a film-coated tablets at the dose of 4 mg.
Placebo
DrugMatching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Cenerimod 4 mgExperimental treatment 1 intervention
Group B: Matching placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Complete renal response (CRR)
CRR at Week 76, defined as (both must be met): * Urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg AND * No decrease from baseline of ≥ 20% in estimated glomerular filtration rate (eGFR)
Time frame
At Week 76Secondary outcomes
1
CRR while maintaining a low dose of corticosteroids
CRR at Week 76 with oral daily dose of 5 mg/day prednisone equivalent or less from Week 24 onwards
Time frame
At Week 762
Sustained CRR
Sustained CRR at Week 76. Sustained CRR is defined as meeting CRR criteria for two consecutive visits (i.e., 3 months apart) and confirmed at Week 76 visit. The second consecutive visit can be the Week 76 visit to qualify as sustained CRR.
Time frame
Up to Week 76Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov