Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07201129
PHASE3

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

Sponsor: Viatris Innovation GmbH

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-02-09

Completion Date

2030-02

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

Cenerimod

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

DRUG

Placebo

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

Locations (6)

SouthCoast Research Center

Miami, Florida, United States

Allied Biomedical Research Institute

Miami, Florida, United States

ProfessionalResearchCenter INC

Miami, Florida, United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Rheumatology Care Center, PLLC

Bellaire, Texas, United States

Northwest Houston Arthritis

Houston, Texas, United States