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Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)

NCT03742037•Viatris Innovation GmbH

View on ClinicalTrials.gov

Summary

The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).

Detailed Description

This is a Phase 2b, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed Informed Consent Form prior to any study-mandated procedure
•Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR) criteria
•A mSLEDAI-2K score ≥ 6 of at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
•Currently treated with stable doses of one or more of the following background medications:
•* NSAIDs
•* Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine)
•* Mycophenolate mofetil (≤ 2 g/day)
•* Mycophenolic acid (≤ 1440 mg/day)
•* Azathioprine (≤ 2 mg/kg/day)
•* Methotrexate (≤ 20 mg/week)
+7 more criteria

Exclusion Criteria

•Active lupus nephritis or a renal biopsy demonstrating immune complex mediated glomerulonephritis compatible with lupus nephritis.
•CNS (Central Nervous System) lupus and severe forms of vasculitis requiring systemic immunosuppressive treatment
•A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis
•History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders
•Subjects 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 six months prior to Screening
•An elevated QT corrected for HR (Heart Rate) on the basis of Fridericia's formula interval of \> 470 ms (females) / \> 450 ms (males)
•History or presence of severe respiratory disease or pulmonary fibrosis
•Active or latent tuberculosis
•Ongoing bacterial, viral or fungal infection that is of clinical concern in the judgment of the investigator or history of any serious infection
•Subjects who have congenital or acquired severe immunodeficiency or known HIV infection or positive HIV testing
+5 more criteria

Locations (148)

Pinnacle Research Group

Anniston, Alabama, United States

University of California San Diego

La Jolla, California, United States

Valerius Medical Group and Research Center

Los Alamitos, California, United States

University of Colorado School of Medicine

Aurora, Colorado, United States

Robert W Levin MD PA

Clearwater, Florida, United States

Center for Rheumatology Immunology and Arthritis

Fort Lauderdale, Florida, United States

Life Clinical Trials

Margate, Florida, United States

D&H National Research Centers INC

Miami, Florida, United States

San Marcus Research Clinic

Miami Lakes, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

Key Dates

Start Date

December 21, 2018

Primary Completion Date

August 31, 2021

Completion Date

August 25, 2022

Last Updated

October 3, 2025

Enrollment

427

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

Cenerimod 0.5 mg

DRUG

Cenerimod 1 mg

DRUG

Cenerimod 2 mg

DRUG

Cenerimod 4 mg

DRUG

Placebo

DRUG

cenerimod 2 mg (ex-4 mg)

DRUG

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Inclusion Criteria

Exclusion Criteria

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