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New treatment option for Nephritis, Lupus
Official title A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
ClinicalTrials.gov ID: NCT07201129
What this study is testing
What is Cenerimod?
Cenerimod is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nephritis, lupus.
Also referred to as ACT-334441.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Main
- Classification of systemic lupus erythematosus (SLE) made according to the 2019 European Alliance of Associations for Rheumatology / American College...
- Renal biopsy within 6 months prior to Screening visit indicating Class III or IV active glomerulonephritis with or without co-existing Class V, OR...
You likely can't join if
- 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...
- Initiation of the induction therapy with the mandatory following background therapy:
See the full eligibility criteria
- Main
- 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...
- 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...
- Initiation of the induction therapy with the mandatory following background therapy:
- 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.
- 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...
- 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 Exclusion Criteria:
- Severe active central nervous system lupus
- History of, or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with the LN assessment and confound the disease activity assessment (e.g., diabetic nephropathy), or...
- History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia, or syncope associated with cardiac disorders.
- Participants who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by...
- Resting heart rate \< 50 bpm as measured by the 12-lead electrocardiogram (ECG) at Screening or at Randomization.
- Diagnosis of active or latent tuberculosis at Screening or within 6 months prior to Screening
- Negative antibody test for varicella-zoster virus
- Positive results for serological markers for hepatitis A, B, C and E indicating acute or chronic infection
- Participants with a positive human immunodeficiency virus (HIV) test or who have any other congenital or acquired immunodeficiency
- Presence of any of the following abnormalities, detected during the ophthalmological evaluation and/or by optical coherence tomography, as evaluated by the site ophthalmologist, during Screening:
- Macular edema of any cause: diabetic, cystoid, tractional.
- Foveal degeneration: macular hole, macular pseudohole, hereditary or degenerative maculopathies.
- Active uveitis, papilledema.
- Retinal neovascularization of any cause and in any location.
- Significant hematology abnormality at Screening:
- Hemoglobin \< 7 g/dL;
- Lymphocyte count \< 500 /μL (0.5 × 10\^9/L);
- White blood cell count \< 1500/μL (1.5 × 10\^9/L) or
- Platelets \< 25,000/μL (25 × 10\^9/L)
- Treatment with the following medications within 5 half-lives of the medication prior to Randomization: Cyclosporine, voclosporin, tacrolimus, sirolimus, cyclophosphamide.
- Treatment with the following medications within 90 days prior to Randomization:
- Leflunomide.
- i.v. immunoglobulins.
- Methotrexate.
- Tyrosine kinase inhibitors.
- Treatment with anifrolumab within 6 months prior to Randomization.
- Treatment with biological immunosuppressive agents, (e.g., anti-tumor necrosis factor [anti-TNF], anti-interleukin-1 [anti-IL1], anti-IL6 therapies) within 90 days prior to Randomization.
- Treatment with B cell-depleting biological agents (e.g., rituximab, obinutuzumab or ocrelizumab) within 12 months prior to Randomization.
- Treatment with any of the following medications any time prior to Screening:
- Alemtuzumab.
- Sphingosine-1-phosphate receptor modulators (e.g., fingolimod).
- Participants previously assigned by chance to cenerimod or placebo in any trial involving cenerimod.
- Pregnancy confirmed via a serum pregnancy test at the Screening visit or a urine/serum pregnancy test at the Randomization visit or planning to become pregnant, or lactating participant.
The study team makes the final eligibility decision.
Where it's taking place
- Kissimmee, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Bellaire, Texas, United States
- El Paso, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kissimmee, Florida, United States; Miami, Florida, United States; Miami Lakes, Florida, United States; Bellaire, Texas, United States; El Paso, Texas, United States; Houston, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.