Lupus Erythematosus, Systemic, Nephritis, Lupus
Conditions
Brief summary
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.
Interventions
DRUGCenerimod
Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.
DRUGPlacebo
Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.
Sponsors
Viatris Innovation GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * 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/
Exclusion criteria
are verified. * Active renal disease defined as urine protein/creatinine ratio ≥ 1 mg/mg, assessed on a 24h urine collection. * eGFR ≥ 15 mL/min/1.73 m\^2. Enrollment of participants with eGFR between ≥ 15 and \< 30 mL/min/1.73 m\^2 requires: * 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. * Initiation of the induction therapy with the mandatory following background therapy: 1. 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. 2. Corticosteroids: 1-3 intravenous (i.v.) pulses of methylprednisolone at 250 to 1000 mg/pulse/day (maximum cumulative 3000 mg) followed by oral prednisone (or equivalent) at 0.5 mg/kg/day with a cap at 40 mg/day. Pulses can be administered during screening and up to 2 weeks prior to screening. Participants who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/kg/day (max 80 mg/day) oral prednisone (or equivalent), within the same window as i.v. pulses. Note: If treatment with an antimalarial or belimumab is taken, it must be initiated at least 4 weeks prior to Screening and must be at stable dose during these 28 days prior to Randomization and continued at a stable dose until End-of-Treatment. Participants on azathioprine must be switched to mycophenolate mofetil or mycophenolate sodium prior to Randomization. * Participants of childbearing potential must agree to: * Use a highly effective method of contraception from the Screening visit up to at least 24 weeks after discontinuation of trial intervention. * Undertake monthly urine pregnancy tests during the trial and up to at least 24 weeks after discontinuation of trial intervention. Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete renal response (CRR) | At Week 76 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRR while maintaining a low dose of corticosteroids | At Week 76 | CRR at Week 76 with oral daily dose of 5 mg/day prednisone equivalent or less from Week 24 onwards |
| Sustained CRR | Up to Week 76 | 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. |
Countries
United States
Contacts
CONTACTViatris Innovation Clinical Trial Information
STUDY_DIRECTORClinical Trials
Viatris Innovation GmbH
Outcome results
None listed