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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus (NCT05648500) is a Phase 3 interventional studying Lupus Erythematosus, Systemic, sponsored by Viatris Innovation GmbH. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Lupus Erythematosus, Systemic, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 420 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: Inclusion criteria at screening: - Signed willing to sign a consent form 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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): * Anti-dsDNA antibodies elevated above normal, * Antinuclear antibodies with a titer of at least 1:160, * Anti-Smith antibody elevated above normal. * Currently treated with one or more of the following SLE background medications that must be stable for at least 30 days prior to Randomization (except OCS, which must be stable for at least 15 days prior to Randomization): * Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine); * Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤ 1.44g/day); * Azathioprine (≤ 2 mg/kg/day); * Methotrexate (≤ 25 mg/week); * 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 i.v. or ≤ 200 mg/week s.c.). * WoCBP must have a negative urine pregnancy test at Randomization. Main 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. * History of clinically relevant bronchial asthma or chronic obstructive pulmonary disease that has required treatment with oral or parenteral CS for more than a total of 2 weeks within the last 6 months prior to Screening. * History or presence of malignancy (except for surgically excised and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma), lymphoproliferative disease, or history of total lymphoid irradiation within 10 years prior to Screening. * Presence of any of the following abnormalities detected during the ophthalmological evaluation and/or by optical coherence tomography (OCT) during screening: * Macular edema of any cause: diabetic, cystoid, tractional. * Foveal degeneration, macular hole, macular pseudohole, hereditary or degenerative maculopathies. * Active uveitis, papilledema. * Retinal neovascularization of any cause and in any location. * History of chronic liver or biliary disease (other than Gilbert's Syndrome) or subjects with alanine aminotransferase or aspartate aminotransferase \> 3 × Upper Limit of Normal (ULN) or total bilirubin \> 1.5 × ULN (unless in the context of known Gilbert's Syndrome). * Significant hematology abnormality at screening assessment: * lymphocyte count \< 500 /μL (0.5 × 10\^9/L); * hemoglobin \< 7 g/dL; * white blood cell count \< 2000/μL (2.0 × 10\^9/L); or * platelets \< 25000/μL (25 × 10\^9/L). * Estimated glomerular filtration rate \< 15 mL/min/1.73 m\^2. * Treatment with the following medications within 15 days or 5 half-lives of the medication (whichever is longer) prior to Randomization: * β-blockers, diltiazem, verapamil, digoxin, digitoxin, or any other anti-arrhythmic or heart-rate -lowering systemic therapy. * QT-prolonging drugs with known risk of torsade de pointes irrespective of indication. * Treatment with the following medications within 30 days or 5 half-lives of the medication (whichever is longer) prior to Randomization: * Cyclophosphamide, cyclosporine, voclosporin, tacrolimus, sirolimus, etc. * Pulse methylprednisolone. * Vaccination with live vaccines (including live vaccines for COVID-19). * Intra-articular, intramuscular or i.v. CS within 6 weeks prior to Randomization. * Treatment with the following medications within 90 days or 5 half-lives of the medication (whichever is longer) prior to Randomization: * Leflunomide. * i.v. immunoglobulins. * Treatment with any investigational agent within 90 days or 5 half-lives of the drug (whichever is longer) prior to Randomization. * Treatment with B cell-depleting biological agents (e.g., rituximab or ocrelizumab) or biological immunosuppressive agents (e.g., anti-tumor necrosis factor \[TNF\], anti-interleukin \[IL\]-1, anti-IL6 therapies), within 12 months prior to Randomization. * Treatment with anifrolumab within 6 months prior to Randomization. * Treatment with any of the following medications any time prior to Screening: * Alemtuzumab, * Sphingosine-1-phosphate receptor modulators (e.g., fingolimod), * Subjects previously randomized to cenerimod or placebo in any trial involving cenerimod.

Treatments Being Tested

DRUG

Cenerimod

Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.

DRUG

Placebo

Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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
IRIS Research and Development, LLC
Plantation, Florida, United States
Renew Health Clinical Research LLC
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
Advance Quality Medical Research
Orland Park, Illinois, United States
Accurate Clinical Research Inc. - Lake Charles
Lake Charles, Louisiana, United States
Louisiana State University School of Medicine section of Rheumatology
New Orleans, Louisiana, United States
Axon Clinical Research -Baltimore
Baltimore, Maryland, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, United States
June DO, PC
Lansing, Michigan, United States
Bronx Care Health and Wellness Center
The Bronx, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05648500), the sponsor (Viatris Innovation GmbH), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05648500 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05648500?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05648500?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05648500. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05648500. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.