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

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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).

Key facts

Study ID

NCT03742037

Run by

Viatris Innovation GmbH

People needed

427

Starts

2018-12-21

Expected to finish

2022-08-25

Last updated by the study team

2026-07-29

Who can join

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

You may qualify if…

• 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)
• Corticosteroids (≤ 40 mg/day prednisone or equivalent)
• Belimumab (≤10 mg/kg every 4 weeks intravenously, or 200 mg/week subcutaneously).
• History or presence of positive autoantibodies measured by central laboratory defined as follows: (a) Positive antinuclear antibody (ANA) test measured by immunofluorescence assay (IFA) with titre ≥1:80; AND/OR (b) positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies with titre ≥30 IU/mL
• Women of childbearing potential:
• Must have a negative serum pregnancy test at Screening
• Must agree to undertake monthly urine pregnancy tests during the study
• Must use highly effective methods of contraception from the screening visit until 6 months after taking the last dose of study treatment.

You may not qualify if…

• 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
• Presence of macular edema or active uveitis
• Type 1 or 2 diabetes that is poorly controlled according to investigator judgment, or diabetes complicated with organ involvement such as diabetic nephropathy or retinopathy
• Significant hematology abnormality: Lymphocyte count < 800 /μL (0.8 × 10e9/L); hemoglobin < 9 g/dL; WBC (White Blood Cell) count < 2500/μL (2.5 × 10e9/L) or platelets < 75000/μL (75 × 10e9/L)
• Estimated glomerular filtration rate < 60 mL/min/1.73 m2
• Known allergy to S1P (sphingosine-1-phosphate) receptor modulators or any of the cenerimod formulation excipients

Where it is running

• 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
• Integral Rheumatology & Immunology Specialists — Plantation, Florida, United States
• Advanced Research Institute Inc Allergy & Rheumatology — St. Petersburg, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• North Georgia Rheumatology Group - Duluth — Lawrenceville, Georgia, United States
• Institute of Arthritis Research — Idaho Falls, Idaho, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Innovative Health Research — Las Vegas, Nevada, United States
• New York Presbyterian Columbia University Medical Center — New York, New York, United States
• State University of New York Upstate Medical University — Syracuse, New York, United States
• Joint Muscle Medical Care and Research Institute - Lilington Office — Charlotte, North Carolina, United States
• DJL Clinical Research — Charlotte, North Carolina, United States
• Paramount Medical Research and Consulting — Middleburg Heights, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Office of Ramesh C. Gupta, MD — Memphis, Tennessee, United States
• Amarillo Center for Clinical Research — Amarillo, Texas, United States
• Pinnacle Research Group — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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