Recruiting

LUMIOSCenerimod for Active Lupus Nephritis in Systemic Lupus Erythematosus

What is being tested

Cenerimod

+ Placebo

Drug

Who is being recruted

Urogenital Diseases+11

+ Autoimmune Diseases

+ Connective Tissue Diseases

From 18 to 75 Years

+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: February 2026

See protocol details

Summary

Principal SponsorViatris Innovation GmbH

Study ContactViatris Innovation Clinical Trial Information

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 9, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on finding out if cenerimod, when used alongside regular treatments, can effectively help adults with systemic lupus erythematosus (SLE) who have active lupus nephritis, a serious kidney complication. Lupus nephritis can lead to severe kidney damage, so discovering an effective treatment is crucial. The trial aims to determine if cenerimod can improve kidney function and assess its safety for patients. This study is important because it could lead to better management and treatment options for those suffering from this condition. Participants in the study will either receive cenerimod or a placebo, which is a harmless substance that looks like the drug but has no active ingredients, every day for about 1.5 years. This is in addition to their regular lupus treatment. They will regularly visit the clinic every 1 to 3 months to undergo checkups and tests to monitor their kidney function and the safety of the treatment. The study will help understand any medical issues that arise from taking cenerimod, providing valuable information on the risks and benefits of this potential treatment.

Official TitleA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy

NCT07201129

Principal SponsorViatris Innovation GmbH

Study ContactViatris Innovation Clinical Trial Information

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesConnective Tissue DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisImmune System DiseasesKidney DiseasesLupus Erythematosus, SystemicLupus NephritisNephritisUrologic DiseasesSkin and Connective Tissue DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

7 inclusion criteria required to participate

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.

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.

Active renal disease defined as urine protein/creatinine ratio ≥ 1 mg/mg, assessed on a 24h urine collection.

Show More Criteria

18 exclusion criteria prevent from participating

Positive results for serological markers for hepatitis A, B, C and E indicating acute or chronic infection

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.

Participants with a positive human immunodeficiency virus (HIV) test or who have any other congenital or acquired immunodeficiency

Treatment with the following medications within 90 days prior to Randomization: * Leflunomide. * i.v. immunoglobulins. * Methotrexate. * Tyrosine kinase inhibitors.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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

Group II

Placebo

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

SouthCoast Research Center

Miami, United StatesOpen SouthCoast Research Center in Google Maps

Recruiting

Allied Biomedical Research Institute

Miami, United States

Recruiting

Northwest Houston Arthritis

Houston, United States

Recruiting

ProfessionalResearchCenter INC

Miami, United States

Recruiting

6 Study Centers