A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous 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.

Key facts

Study ID

NCT05672576

Run by

Viatris Innovation GmbH

People needed

451

Starts

2023-06-26

Expected to finish

2027-05-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria at screening:
• 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).
• Oral Corticosteroids (OCS):
• if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.
• if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent.
• Belimumab (≤10 mg/kg every 4 weeks intravenously [i.v.], or 200 mg/week subcutaneously [s.c.]).
• Treatment with antimalarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate or belimumab must have been started at least 90 days prior to Screening. Treatment with OCS must have been started at least 30 days prior to Screening.
• For women of childbearing potential (WoCBP):
• Negative serum pregnancy test at Screening.
• Agreement to undertake monthly urine pregnancy tests from Randomization up to 6 months after study treatment discontinuation.
• Agreement to use a highly effective method of contraception from Screening (Visit 1) up to 6 months after study treatment discontinuation.
• Inclusion criteria at randomization:
• A clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
• BILAG Grade B in 2 or more organ systems or a BILAG Grade A in 1 or more organ system.
• PGA score ≥ 1.0 on a 0 to 3 visual analog scale.
• Presence of at least one of the following biomarkers of serological evidence of active SLE (in a Screening sample as measured by central laboratory):

Where it is running

• Tucson Clinical Research Institute, LLC — Tucson, Arizona, United States
• UCSD Perlman Medical Offices — La Jolla, California, United States
• Amicis Research Center — Northridge, California, United States
• Hope Clinical Trials, Inc. — Coral Gables, Florida, United States
• Vital Pharma Research — Hialeah, Florida, United States
• Tectum Medical Research — Hollywood, Florida, United States
• Alloy Clinical Research, LLC — Kissimmee, Florida, United States
• Allied Biomedical Research Institute — Miami, Florida, United States
• D&H National Research Centers INC — Miami, Florida, United States
• Professional research Center INC — Miami, Florida, United States
• San Marcus Research Clinic, Inc. — Miami Lakes, Florida, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• RB Wellness Clinic — Las Vegas, Nevada, United States
• Columbia University Medical Center — New York, New York, United States
• Precision Comprehensive Clinical Research Solutions — Colleyville, Texas, United States
• Texas Arthritis Center — El Paso, Texas, United States
• Northwest Houston Arthritis Center — Houston, Texas, United States
• Biomedica Research Group — Providencia, Chile
• Sociedad Médica del Aparato Locomotor S. A. — Providencia, Chile
• Estudios G y C Ltda — Santiago, Chile
• Enroll SpA — Santiago, Chile
• Centro de Especialidades Medicas Vanguardia — Temuco, Chile
• Clinical Research Chile SpA — Valdivia, Chile
• Hospital San José de Victoria — Victoria, Chile
• MICS Centrum Medyczne Warszawa — Warsaw, Poland

Full record on ClinicalTrials.gov

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