A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment

NCT ID: NCT07201129

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2030-02-28

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.

Conditions

Nephritis, Lupus; Lupus Erythematosus, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cenerimod 4 mg

Participants will receive cenerimod once daily in addition to background lupus nephritis (LN) therapy.

Group Type: EXPERIMENTAL

Cenerimod

Intervention Type: DRUG

Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.

Matching placebo

Participants will receive matching placebo once daily in addition to background LN therapy.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.

Interventions

Cenerimod

Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.

Intervention Type: DRUG

Placebo

Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.

Intervention Type: DRUG

Other Intervention Names

ACT-334441

Eligibility Criteria

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.

Exclusion Criteria

• 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 Visit 1 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.

• 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 require dialysis, transplantation or end-stage renal disease.
• 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 the New York Heart Association Class III/IV within 6 months prior to Screening.
• 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 randomized to cenerimod or placebo in any trial involving cenerimod.
• Pregnancy confirmed via a serum pregnancy test at Visit 1 or a urine/serum pregnancy test at Visit 2 or planning to become pregnant, or lactating participant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viatris Innovation GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Viatris Innovation GmbH

Locations

Allied Biomedical Research Institute

Miami, Florida, United States

Countries

United States

Central Contacts

Viatris Innovation Clinical Trial Information

Role: CONTACT

viatrisinnovationclinicaltrials@viatris.com

+1 908 435 2675

Other Identifiers

ID-064B301

Identifier Type: -

Identifier Source: org_study_id