RecruitingPhase 3NCT07201129

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

A 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


Sponsor

Viatris Innovation GmbH

Enrollment

300 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cenerimod and a drug called Placebo for people with lupus erythematosus, systemic and nephritis, lupus. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(14)

Dolphin Medical Research

Doral, Florida, United States

Alloy Clinical Research LLC

Kissimmee, Florida, United States

SouthCoast Research Center

Miami, Florida, United States

Allied Biomedical Research Institute

Miami, Florida, United States

DH NationalResearchCenters INC

Miami, Florida, United States

ProfessionalResearchCenter INC

Miami, Florida, United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Revive Research Institute, LLC

Sterling Heights, Michigan, United States

Rheumatology Care Center, PLLC

Bellaire, Texas, United States

Texas Arthritis Center

El Paso, Texas, United States

Novel Research, LLC.

Houston, Texas, United States

Northwest Houston Arthritis

Houston, Texas, United States

Discovery Clinical Trials LLC

San Antonio, Texas, United States

Azul Bioresearch Llc

Sugarland, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07201129


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