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

RECRUITINGPHASE3

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

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

NCT05648500•Viatris Innovation GmbH

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed Informed Consent Form (ICF) prior to any study-mandated procedure.
•Diagnosis of Systemic Lupus Erythematosus (SLE) made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism / American College of Rheumatology Criteria.
•A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score ≥ 6 and clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). The mSLEDAI-2K score does not include "leukopenia".
•British Isles Lupus Assessment Group-2004 (BILAG) Grade B in ≥ 2 organ systems or a BILAG Grade A in ≥ 1 organ system.
•Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 visual analog scale.
•Currently treated with one or more of the following SLE background medications:
•* Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine).
•* Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤1.44 g/day).
•* Azathioprine (≤ 2 mg/kg/day).
•* Methotrexate (≤ 25 mg/week).
+26 more criteria

Exclusion Criteria

•Pregnant, planning to be become pregnant up to Final Study Visit, or lactating women.
•Severe active central nervous system lupus or active severe or unstable neuropsychiatric SLE including but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; or mononeuritis multiplex:
•* That would make the subject unable to fully understand the ICF; OR
•* Where, in the opinion of the investigator/delegate, protocol-specified standard of care is insufficient and the use of a more aggressive therapeutic approach, such as adding i.v. cyclophosphamide and/or high dose i.v. pulse corticosteroid (CS) therapy or other treatments not permitted in the protocol is indicated.
•A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis or uncontrolled autoimmune thyroid disease.
•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 6 months prior to Screening.
•Resting heart rate \< 50 bpm as measured by the 12-lead ECG at Screening or at Randomization.
•An elevated QT interval corrected according to Fridericia's formula (QTcF) interval of \> 470 ms (females) / \> 450 ms (males) at Screening or at Randomization.
•History or presence of severe respiratory disease or pulmonary fibrosis, based on medical history, lung function, and chest X-ray (or CT scan as per local guidelines), performed at Screening or within 6 months prior to Screening.
+32 more criteria

Locations (214)

Providence Medical Foundation

Fullerton, California, United States

California Research Institute

Huntington Park, California, United States

University of Colorado Denver

Aurora, Colorado, United States

RASF-Clinical Research Inc.

Boca Raton, Florida, United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Omega Research MetroWest, LLC

DeBary, Florida, United States

Alloy Clinical Research, LLC

Kissimmee, Florida, United States

SouthCoast Research Center, Inc.

Miami, Florida, United States

Allied Biomedical Research Institute

Miami, Florida, United States

Professional research Center INC

Miami, Florida, United States

Key Dates

Start Date

December 13, 2022

Primary Completion Date

October 31, 2026

Completion Date

May 1, 2027

Last Updated

March 3, 2026

Enrollment

420

ESTIMATED participants

Conditions

Lupus Erythematosus, Systemic

Interventions

Cenerimod

DRUG

Placebo

DRUG

Contacts

Viatris Innovation Clinical Trial Information

CONTACT

+1 908 435 2675 viatrisinnovationclinicaltrials@viatris.com

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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: March 3, 2026Data 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.

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

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

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