A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
OPUS-2
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
3 other identifiers
interventional
451
18 countries
147
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2023
Typical duration for phase_3
147 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2023
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 2, 2026
August 1, 2025
3.4 years
January 3, 2023
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline
Response on SRI-4 is defined as: * Reduction from baseline of at least 4 points in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 score (mSLEDAI-2K \[SLEDAI-2K modified to exclude leukopenia, thus mSLEDAI-2K\]), and * No new British Isles Lupus Assessment Group-2004 (BILAG) A organ domain score and not more than one new BILAG B organ domain score compared to baseline, and * No worsening from baseline in subjects' lupus disease activity, where worsening is defined as an increase ≥ 0.30 points on a 3-point Physician's Global Assessment visual analog scale (PGA VAS), and * No violation of specified medication rules detailed in the core protocol.
At Month 12 compared to Day 1 (pre-dose baseline)
Secondary Outcomes (3)
Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline
At Month 12 compared to Day 1 (pre-dose baseline)
Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response
Day 1 (pre-dose baseline) to Month 12
Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations (i.e., rash, alopecia, mucosal ulcers)
Day 1 (pre-dose baseline) to Month 12
Study Arms (2)
Cenerimod 4 mg
EXPERIMENTALParticipants will receive cenerimod once daily in addition to background SLE therapy.
Placebo
PLACEBO COMPARATORParticipants will receive matching placebo once daily in addition to background SLE therapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +21 more criteria
You may not qualify if:
- 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.
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (147)
Tucson Clinical Research Institute, LLC
Tucson, Arizona, 85712, United States
UCSD Perlman Medical Offices
La Jolla, California, 92037-0943, United States
Amicis Research Center
Northridge, California, 91234, United States
Hope Clinical Trials, Inc.
Coral Gables, Florida, 33134, United States
Vital Pharma Research
Hialeah, Florida, 33016, United States
Tectum Medical Research
Hollywood, Florida, 33024, United States
Alloy Clinical Research, LLC
Kissimmee, Florida, 34741, United States
Allied Biomedical Research Institute
Miami, Florida, 33155, United States
D&H National Research Centers INC
Miami, Florida, 33155, United States
Professional research Center INC
Miami, Florida, 33172, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
RB Wellness Clinic
Las Vegas, Nevada, 89102, United States
Columbia University Medical Center
New York, New York, 10032, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034, United States
Texas Arthritis Center
El Paso, Texas, 79902, United States
Northwest Houston Arthritis Center
Houston, Texas, 77090, United States
Biomedica Research Group
Providencia, 7500710, Chile
Sociedad Médica del Aparato Locomotor S. A.
Providencia, 7510186, Chile
Estudios G y C Ltda
Santiago, 7500504, Chile
Enroll SpA
Santiago, 7500587, Chile
Centro de Especialidades Medicas Vanguardia
Temuco, 4810345, Chile
Clinical Research Chile SpA
Valdivia, 5110683, Chile
Hospital San José de Victoria
Victoria, 4720001, Chile
iMedica s.r.o.
Brno, 60200, Czechia
Institute of Rheumatology Prague
Prague, 12800, Czechia
LTD "New Plasma Clinic"
Batumi, 6010, Georgia
Institute of Clinical Cardiology, Ltd
Tbilisi, 0159, Georgia
LTD "Tbilisi Central Hospital"
Tbilisi, 0159, Georgia
National Institute of Endocrinology Ltd.
Tbilisi, 0159, Georgia
Tbilisi Heart and Vascular Clinic Ltd.
Tbilisi, 0159, Georgia
Aversi Clinic LTD
Tbilisi, 0160, Georgia
Medi Club Georgia Ltd.
Tbilisi, 0160, Georgia
Tbilisi Institute of Medicine
Tbilisi, 0160, Georgia
JSC Jerarsi Clinic
Tbilisi, 0167, Georgia
Ltd. Mtskheta Street Clinic
Tbilisi, 0179, Georgia
The First Medical Center Ltd.
Tbilisi, 0180, Georgia
Caucasus Medical Centre
Tbilisi, 0186, Georgia
LLC "Innova"
Tbilisi, 0186, Georgia
LLC Raymann
Tbilisi, 0186, Georgia
LTD "Tbilisi Heart Center"
Tbilisi, 0186, Georgia
Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP
Frankfurt am Main, 60596, Germany
Universitätsklinikum Leipzig
Leipzig, 4103, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Universitätsklinikum Münster (UKM)
Münster, 48149, Germany
Shalby Hospitals
Ahmedabad, 380015, India
Chennai Meenakshi Multispeciality Hospital Pvt. Ltd.
Chennai, 600004, India
ESIC Medical College and Hospital
Hyderabad, 500038, India
IPGME&R and SSKM Hospital
Kolkata, 700020, India
Jasleen Hospital
Nagpur, 440012, India
Chopda Medicare & Research Centre
Nashik, 422005, India
AIIMS New Delhi
New Delhi, 110029, India
Center for Rheumatic Diseases
Pune, 411001, India
Yashoda Hospital
Secunderabad, 500003, India
Nirmal Hospital Private Limited
Surat, 395002, India
Hospital Selayang
Batu Caves, 68100, Malaysia
Universiti Kebangsaan Malaysia - Medical Centre
Cheras, 56000, Malaysia
Hospital Tuanku Fauziah, Kangar
Kangar, 01000, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Hospital Sibu, Sarawak
Sibu, 96000, Malaysia
Consultorio Particular Dr. Miguel Cortés Hernández
Cuernavaca, 62448, Mexico
Centro Integral en Reumatologia SA de CV (CIRSA)
Guadalajara, 44160, Mexico
Morales Vargas Centro de Investigación S.C.
León, 37000, Mexico
Boca Clinical Trials Mexico, S.C.
Mexico City, 01120, Mexico
Centro de Investigación Clínica GRAMEL, S.C.
Mexico City, 03720, Mexico
Clinstile, S.A. de C.V.
Mexico City, 06700, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P. (CEMDEICY S.C.P.)
Mérida, 97130, Mexico
Accelerium, S. de R.L. de C.V.
Monterrey, 64000, Mexico
UBAM Unidad Biomédica Avanzada Monterrey
Monterrey, 64460, Mexico
Oaxaca contra el Cáncer A.C
Oaxaca City, 68000, Mexico
Centro de Estudios Clínicos de Querétaro S.C.
Querétaro, 76000, Mexico
Clinical Research Institute S.C.
Tlalnepantla, 54055, Mexico
PCR Toluca - Phylasis Clinical Research
Toluca, 50090, Mexico
Unidad de Investigación en Medicina Interna y Enfermedades Críticas / Hogar Clínica San Juan de Dios
Cayma, 04017, Peru
Centro de Investigacion Clinica Inmunoreumatologia / ACQ Medic SAC
Jesús María, 15076, Peru
Centro de Investigación del Hospital Militar Central
Jesús María, 15076, Peru
Alberto Sabogal Sologuren National Hospital
Lima, 07011, Peru
Hospital Maria Auxiliadora
Lima, 15828, Peru
Unidad de Investigación de la Clinica International
San Borja, 15036, Peru
Instituto Peruano del Hueso y la Articulación S.A.C. (IPHAR)
San Isidro, 15046, Peru
Clínica Anglo Americana
San Isidro, 15073, Peru
Servicios Reumatológicos SOMA E.I.R.L. / Clinica El Golf
San Isidro, 15076, Peru
Unidad de Investigación en Reumatología e Inmunología CSJB
San Juan de Lurigancho, 15431, Peru
Hospital Nacional Cayetano Heredia
San Martín de Porres, 15102, Peru
Investigaciones Clinicas / Instituto de Ginecología y Reproducción, El Derby
Santiago de Surco, 15023, Peru
Centro de Investigación Clínica Trujillo EIRL / Clínica Peruano Americana S.A
Trujillo, 13011, Peru
Iloilo Doctors Hospital
Iloilo City, 5000, Philippines
Makati Medical Center
Makati, 1229, Philippines
Ospital ng Makati
Makati City, 1218, Philippines
St Lukes Medical Center
Manila, 1102, Philippines
The Medical City Clark
Pampanga, 2023, Philippines
St Luke's Medical Center Quezon City / University of Santo Tomas Hospital
Sampaloc, 1015, Philippines
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Santa Sp. z o.o.
Lodz, 90-302, Poland
Medyczne Centrum Hetmańska
Poznan, 60-218, Poland
Twoja Przychodnia Poznańskie Centrum Medyczne
Poznan, 61-293, Poland
Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, 71-252, Poland
MICS Centrum Medyczne Warszawa
Warsaw, 00-874, Poland
Hospital Prof. Doutor Fernando Fonseca
Amadora, 2720-276, Portugal
Centro Hospitalar Universitário do Algarve - Hospital de Faro
Faro, 8000-386, Portugal
ULS Guarda
Guarda, 6300-749, Portugal
Hospital Senhora Oliveira-Guimaraes
Guimarães, 4835-044, Portugal
Instituto Portugues De Reumatologia
Lisbon, 1050-034, Portugal
Unidade Local De Saude Lisboa Ocidental E.P.E.
Lisbon, 1349-019, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502, Portugal
Centro Reumatologico de Caguas
Caguas, 00725, Puerto Rico
GCM Medical Group, PSC
San Juan, 917, Puerto Rico
Institute of Rheumatology, Belgrade (study site 1)
Belgrade, 11000, Serbia
Institute of Rheumatology, Belgrade (study site 2)
Belgrade, 11000, Serbia
Institute of Rheumatology, Belgrade (study site 3)
Belgrade, 11000, Serbia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11040, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Special Hospital for Rheumatic Diseases, Novi Sad
Novi Sad, 21000, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, 23000, Serbia
Arthritis Clinical Research Trials
Cape Town, 7405, South Africa
Panorama Medical Centre
Cape Town, 7500, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, 2193, South Africa
University of Pretoria
Pretoria, 0002, South Africa
Winelands Medical Research
Somerset West, 7130, South Africa
Accellacare
Alcobendas, 28100, Spain
Parc Tauli Sabadell University Hospital
Barcelona, 08208, Spain
Hospital Universitari Vall d'Hebron
Colmenar Viejo, 08035, Spain
Hospital Universitario Ramon y Cajal
Colmenar Viejo, 28770, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Clinica Gaias Santiago
Santiago de Compostela, 15702, Spain
Hospital QuironSalud Sagrado Corazon
Seville, 41013, Spain
Hospital Universitario Nuestra Señora de Valme
Seville, 41014, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Hospital Universitario Río Hortega de Valladolid
Valladolid, 47012, Spain
Communal Non-profit Enterprise "Chernihiv Regional Hospital" of the Chernihiv Regional Council, Rheumatology Department
Chernihiv, 14029, Ukraine
St. Luke's Treatment and Diagnostic Center
Ivano-Frankivsk, 76019, Ukraine
Medical Center "Harmoniia krasy", LLC
Kyiv, 01135, Ukraine
Medical Center of the Limited Liability Company "Edelweiss Medics", Treatment and Prevention Department
Kyiv, 02002, Ukraine
Med Center "Ok!Clinic+" of Ltd Liability Com "Inter Ins of Clin Rsrch", Inpatient dprt, Unit of Ther, Rheuma and Cardio
Kyiv, 02091, Ukraine
"Medbud-Clinic" LLC, Treatment and Prevention Department of the Medical Center
Kyiv, 03037, Ukraine
Medical Center "Universal Clinic "Oberih"" of Limited Liability Company "Capital"
Kyiv, 03057, Ukraine
Limited Liability Company "Medical Centre 'Consilium Medical'", Clinical and Consultation Department
Kyiv, 04050, Ukraine
Medical Center "Center of Family Medicine Plus" LLC, Treatment and Prevention Department
Kyiv, 04210, Ukraine
Ternopil Regional Clinical Hospital
Ternopil, 46002, Ukraine
"Medical Center Health Clinic" LLC, Medical Clinical Investigational Center, Department of Cardiology and Rheumatology
Vinnytsia, 21009, Ukraine
Communal Non-Com Entr Vinnytsia City Clin Hpt 1, Clin Therapy Dprt 2, Vinnytsia Nat Pirogov Memo Med Uni, Dprt of Internal Med 3
Vinnytsia, 21029, Ukraine
University Hospitals of Leicester Nhs Trust
Leicester, LE5 4PW, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust - Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (1)
Askanase AD, D'Cruz D, Kalunian K, Merrill JT, Navarra SV, Cahuzac C, Cornelisse P, Murphy MJ, Strasser DS, Trokan L, Berkani O. Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Rheumatol. 2025 Jan;7(1):e21-e32. doi: 10.1016/S2665-9913(24)00246-7. Epub 2024 Nov 22.
PMID: 39586304DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Viatris Innovation GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2023
First Posted
January 5, 2023
Study Start
June 26, 2023
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
April 2, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share