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Active, not recruiting Phase 3 Interventional

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

ClinicalTrials.gov ID: NCT05648500

Public ClinicalTrials.gov record NCT05648500. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 7:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. The main questions it aims to answer are: * How well cenerimod works on top of the treatment already being administered. * How safe cenerimod is for adult patients with Systemic Lupus Erythematosus. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

Study identification

NCT ID
NCT05648500
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Viatris Innovation GmbH
Industry
Enrollment
470 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 13, 2022 (Actual)
Primary completion
Mar 31, 2027 (Estimated)
Completion
Sep 30, 2027 (Estimated)
Last update posted
Sep 15, 2026

2022 – 2027

United States locations

U.S. sites
22
U.S. states
11
U.S. cities
19
Facility City State ZIP Site status
California Research Institute Huntington Park California 90255 —
University of Colorado Denver Aurora Colorado 80045 —
Clinical Research of West Florida, Inc. Clearwater Florida 33765 —
Omega Research MetroWest, LLC DeBary Florida 32713 —
Alloy Clinical Research, LLC Kissimmee Florida 34741 —
SouthCoast Research Center, Inc. Miami Florida 33136 —
Allied Biomedical Research Institute Miami Florida 33155 —
Professional research Center INC Miami Florida 33172 —
IRIS Research and Development, LLC Plantation Florida 33324-2736 —
Augusta University Augusta Georgia 30912 —
Advance Quality Medical Research Orland Park Illinois 60462 —
Accurate Clinical Research Inc. - Lake Charles Lake Charles Louisiana 70605 —
Louisiana State University School of Medicine section of Rheumatology New Orleans Louisiana 70112 —
Axon Clinical Research -Baltimore Baltimore Maryland 21237 —
Bronx Care Health and Wellness Center The Bronx New York 10457 —
DJL Clinical Research, PLLC Charlotte North Carolina 28210 —
University of Oklahoma College of Medicine Oklahoma City Oklahoma 73117 —
Accurate Clinical Research Inc. Baytown Texas 77521 —
Rheumatology Care Center, PLLC Bellaire Texas 77041 —
Houston MD Medspa and Wellness Clinic Houston Texas 77084 —
Accurate Clinical Research Inc. Houston Texas 77089 —
Sun Research Institute San Antonio Texas 78215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 176 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05648500, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 15, 2026 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05648500 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →