Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
July 13, 2026 updated by: Viatris Innovation GmbH
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)
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).
Study Overview
Status
Completed
Conditions
Detailed Description
This is a Phase 2b, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).
Study Type
Interventional
Enrollment (Actual)
427
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Plovdiv, Bulgaria, 4002
- University Multiprofile Hospital for Active Treatment Pulmed
-
Sofia, Bulgaria, 1431
- Diagnostic and Consulting Center "Aleksandrovska" EOOD
-
Sofia, Bulgaria, 1463
- Diagnostic Consulting Center Fokus-5
-
-
Plodiv
-
Plovdiv, Plodiv, Bulgaria, 4002
- Multiprofile Hospital For Active Treatment Trimontium
-
-
-
-
-
Santiago, Chile, 7500710
- Biomedica Research Group
-
Santiago, Chile, 7500588
- Enroll SpA
-
Santiago, Chile, 8330008
- Meditek Ltda.
-
Santiago, Chile, 8380456
- Prosalud
-
Valdivia, Chile, 5110683
- Clinical Research Chile SpA
-
-
-
-
Vychodocesky KRAJ
-
Pardubice, Vychodocesky KRAJ, Czechia, 530 02
- CCR Pardubice
-
-
-
-
-
Pessac, France, 33604
- Hôpital Haut-Lévêque
-
-
Brittany Region
-
Brest, Brittany Region, France, 29609
- Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest
-
-
-
-
-
Batumi, Georgia, 6010
- LTD "New Plasma Clinic"
-
Tbilisi, Georgia, 0186
- Multiprofile Clinic Consilium Medulla
-
Tbilisi, Georgia, 0160
- Aversi Clinic LTD
-
Tbilisi, Georgia, 0160
- Medi Club Georgia Ltd.
-
Tbilisi, Georgia, 0186
- Medicore
-
Tbilisi, Georgia, 0179
- Ltd. Mtskheta Street Clinic
-
Tbilisi, Georgia, 0180
- The First Medical Center Ltd.
-
Tbilisi, Georgia, 0186
- LLC "Innova"
-
Tbilisi, Georgia, 0186
- LLC Raymann
-
Tbilisi, Georgia, 0186
- LTD "Tbilisi Heart Center"
-
-
-
-
-
Karlsruhe, Germany, 76133
- Städtisches Klinikum Karlsruhe gGmbH
-
-
-
-
-
Goudi, Greece, 11527
- General Hospital of Athens "Laiko"
-
-
-
-
Budapest
-
Budapest, Budapest, Hungary, 1097
- Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet
-
-
-
-
-
Haifa, Israel, 3339419
- Bnai Zion Medical Center
-
Haifa, Israel, 3109601
- Rambam healthcare campus
-
Nahariya, Israel, 2210001
- Galilee Medical Center
-
Ramat Gan, Israel, 5265601
- The Chaim Sheba Medical Center
-
-
-
-
-
Genova, Italy, 16132
- LUPUS CLINIC c/o DIMI
-
Milan, Italy, 20132
- Ospedale San Raffaele
-
Milan, Italy, 20122
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
-
Roma, Italy, 00168
- Fondazione Policlinico Universitario A. Gemelli
-
Roma, Italy, 00158
- Azienda Ospedaliera San Camillo Forlanini
-
-
Torino
-
Torino, Torino, Italy, 10128
- A.O. Mauriziano Umberto I di Torino
-
-
-
-
-
Tomakomai-shi, Japan, 053-0034
- Tomakomai City Hospital
-
-
-
-
-
Cuernavaca, Mexico, 62448
- Consultorio Particular Dr. Miguel Cortés Hernández
-
Guadalajara, Mexico, 44160
- Centro Integral en Reumatología S.A. de C.V.
-
Guadalajara, Mexico, 44600
- Icle S.C.
-
Guadalajara, Mexico, 44650
- Consultorio Privado de Especialidad del Dr. José Javier Orozco Alcalá
-
Guadalajara, Mexico, 45040
- Consultorio Médico del Dr. Federico Galván Villegas
-
León, Mexico, 37000
- Morales Vargas Centro de Investigación S.C.
-
Mexico City, Mexico, 03720
- Centro de Investigación Clínica GRAMEL, S.C.
-
Mexico City, Mexico, 6700
- Biológicos Especializados S.A. de C.V.
-
Mexico City, Mexico, 01120
- Karla Adriana Espinosa Bautista
-
Monterrey, Mexico, 64460
- UBAM Unidad Biomedica Avanzada Monterrey
-
Monterrey, Mexico, 64000
- Accelerium, S. de R.L. de C.V.
-
Mérida, Mexico, 97000
- Unidad de Atención Médica e Investigación en Salud
-
Mérida, Mexico, 97070
- Kohler & Milstein Research S.A. De C.V.
-
Querétaro, Mexico, 76070
- SMIQ, S. de R.L. de C.V.
-
Saltillo, Mexico, 25000
- Hospital Universitario "Dr. Gonzalo Valdés Valdés"
-
San Luis Potosí City, Mexico, 78290
- Unidad de Investigaciones Reumatológicas A.C.
-
San Luis Potosí City, Mexico
- Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
-
Zapopan, Mexico, 45030
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
-
-
-
-
-
Angeles City, Philippines
- Angeles University Foundation Medical Center
-
Davao City, Philippines, 8000
- Davao Doctors Hospital
-
Iloilo City, Philippines, 5000
- Iloilo Doctors Hospital
-
Makati City, Philippines, 1229
- Makati Medical Center
-
Manila, Philippines, 1000
- University of the Philippines Manila - Philippine General Hospital
-
Manila, Philippines, 1003
- Jose R. Reyes Memorial Medical Center
-
Manila, Philippines, 1015
- University of Santo Tomas Hospital
-
Quezon City, Philippines, 1102
- St. Luke's Medical Center
-
Quezon City, Philippines, 1118
- Far Eastern University - Nicanor Reyes Medical Foundation
-
-
Batangas
-
Lipa City, Batangas, Philippines, 4217
- Lipa Medix Medical Center
-
-
-
-
-
Bydgoszcz, Poland, 85-168
- Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
-
Kościan, Poland, 64-000
- Intermedius Uslugi Medyczne
-
Krakow, Poland, 30-363
- Centrum Medyczne Plejady
-
Krakow, Poland, 30-121
- Szpital Specjalistyczny im. J. Dietla w Krakowie
-
Poznan, Poland, 61-293
- Twoja Przychodnia Poznanskie Centrum Medyczne
-
Ustroń, Poland, 43-450
- Śląskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepełnosprawności im gen. Jerzego Zi
-
-
-
-
-
Caguas, Puerto Rico, 00725
- Centro Reumatologico de Caguas
-
-
-
-
-
Brasov, Romania, 500283
- Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
-
Bucharest, Romania, 11172
- Spitalul Clinic "Sf. Maria"
-
Bucharest, Romania, 11025
- SC Sana Monitoring SRL
-
Cluj-Napoca, Romania, 400006
- Spitalul Clinic Judetean de Urgenta Cluj-Napoca
-
-
-
-
-
Chelyabinsk, Russia, 454076
- Chelyabinsk Regional Clinical Hospital
-
Moscow, Russia, 111539
- City Clinical Hospital #15 named after O.M. Filatova
-
Moscow, Russia, 115522
- Federal State Budget Scientific Research Institution "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
-
Moscow, Russia, 125315
- Non-governmental private healthcare organization, Scientific Clinical Centre of JSC Russian Railways
-
Novosibirsk, Russia, 630099
- Medical Center "Zdorovaya Semiya", LLC
-
Orenburg, Russia, 460018
- Orenburg State Medical University
-
Saint Petersburg, Russia, 190068
- Clinical Rheumatological Hospital Number 25
-
Saint Petersburg, Russia, 191045
- Military Medical Academy S.M. Kirov
-
Saint Petersburg, Russia, 192007
- Polyclinic of Private Security and Detectives
-
Saint Petersburg, Russia, 196006
- Medical Research Institute, LLC
-
Saint Petersburg, Russia, 650066
- Medical Center Maksimum Zdorovia
-
Saratov, Russia, 410053
- Saratov Regional Clinical Hospital
-
Yaroslavl, Russia, 150030
- State Institution of Health Protection "Clinical Hospital #8"
-
Yekaterinburg, Russia, 620043
- JSC "Center of Family Medicine"
-
-
-
-
-
Barcelona, Spain, 08036
- Hospital Clinic i Provincial de Barcelona
-
Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
-
Valencia, Spain, 46017
- Hospital Universitario Doctor Peset
-
-
MALAGA
-
Málaga, MALAGA, Spain, 29009
- Hospital Universitario Regional de Málaga
-
-
SEVILLA
-
Seville, SEVILLA, Spain, 41010
- Hospital Quironsalud Infanta Luisa
-
-
-
-
-
Kaohsiung City, Taiwan, 81362
- Kaohsiung Veterans General Hospital
-
Kaohsiung City, Taiwan, 80756
- Kaohsiung Medical University Hospital
-
-
-
-
-
Bangkok, Thailand, 10400
- Rajavithi Hospital
-
Songkhla, Thailand, 90110
- Songklanagarind Hospital
-
-
-
-
-
Istanbul, Turkey (Türkiye), 34098
- Istanbul Universitesi Istanbul Tip Fakultesi
-
Konya, Turkey (Türkiye), 42080
- Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi
-
-
-
-
-
Kyiv, Ukraine, 02125
- Kyiv City Clinical Hospital №3
-
Kyiv, Ukraine, 03151
- Clinic of State Institution "National Scientific Centre "Acad. Strazhesko Institute of Cardiology"
-
Kyiv, Ukraine, 04050
- Medical Centre "Consilium medical"
-
Kyiv, Ukraine, 04107
- Municipal Institution Kyiv Regional Council "Kyiv Regional Clinical Hospital"
-
Lviv, Ukraine, 79010
- Lviv Regional Clinical Hospital
-
Lviv, Ukraine, 79000
- Municipal Nonprofit Institution of Lviv Regional Council "Lviv Regional Clinical Hospital"
-
Lviv, Ukraine, 79000
- Municipal Nonprofit Institution of Lviv Regional Council
-
Poltava, Ukraine, 36011
- Poltava Regional Clinical Hospital named after M.V. Sklifossovsky
-
Ternopil, Ukraine, 46001
- Ternopil University Clinic - Rheumatology department
-
Uzhhorod, Ukraine, 88000
- Zakarpattya Regional Clinical Hospital n.a. A.Novak - Rheumatology Department
-
Vinnytsia, Ukraine, 21001
- Private Small Scale Medical Center "Pulse"
-
Vinnytsia, Ukraine, 21009
- Medical Center "Health Clinic", LLC
-
Vinnytsia, Ukraine, 21018
- Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital №1"
-
Vinnytsia, Ukraine, 21029
- Scientific and Research Institute of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU,
-
Vinnytsia, Ukraine, 21018
- Vinnytsya Regional Clinical Hospital - Rheumatology Department
-
Zaporizhzhya, Ukraine, 69600
- Municipal Institution "Zaporizhzhya Regional Clinical Hospital"
-
Zhytomyr, Ukraine, 10002
- Municipal institution "Regional Clinical Hospital n.a. O.F. Herbachevskoho"
-
-
-
-
-
Cambridge, United Kingdom, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust
-
London, United Kingdom, SE1 9RT
- Guy's and Saint Thomas' NHS Foundation Trust
-
-
-
-
Alabama
-
Anniston, Alabama, United States, 36207
- Pinnacle Research Group
-
-
California
-
La Jolla, California, United States, 92037-0493
- University Of California San Diego
-
Los Alamitos, California, United States, 90720-5403
- Valerius Medical Group and Research Center
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado School of Medicine
-
-
Florida
-
Clearwater, Florida, United States, 33765
- Robert W Levin MD PA
-
Fort Lauderdale, Florida, United States, 33309
- Center for Rheumatology Immunology and Arthritis
-
Margate, Florida, United States, 33063
- Life Clinical Trials
-
Miami, Florida, United States, 33155
- D&H National Research Centers INC
-
Miami Lakes, Florida, United States, 33014
- San Marcus Research Clinic
-
Ormond Beach, Florida, United States, 32174-1139
- Millennium Research
-
Plantation, Florida, United States, 33324
- Integral Rheumatology & Immunology Specialists
-
St. Petersburg, Florida, United States, 33708
- Advanced Research Institute Inc Allergy & Rheumatology
-
Tampa, Florida, United States, 33603
- Axiom Clinical Research of Florida
-
-
Georgia
-
Lawrenceville, Georgia, United States, 30046
- North Georgia Rheumatology Group - Duluth
-
-
Idaho
-
Idaho Falls, Idaho, United States, 83404
- Institute of Arthritis Research
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Nevada
-
Las Vegas, Nevada, United States, 89128
- Innovative Health Research
-
-
New York
-
New York, New York, United States, 10032
- New York Presbyterian Columbia University Medical Center
-
Syracuse, New York, United States, 13210
- State University of New York Upstate Medical University
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28210
- DJL Clinical Research
-
Charlotte, North Carolina, United States, 28204
- Joint Muscle Medical Care and Research Institute - Lilington Office
-
-
Ohio
-
Middleburg Heights, Ohio, United States, 44130
- Paramount Medical Research and Consulting
-
-
Pennsylvania
-
Duncansville, Pennsylvania, United States, 16635
- Altoona Center for Clinical Research
-
-
Tennessee
-
Memphis, Tennessee, United States, 38119
- Office of Ramesh C. Gupta, MD
-
-
Texas
-
Amarillo, Texas, United States, 79124
- Amarillo Center for Clinical Research
-
Houston, Texas, United States, 77034
- Accurate Clinical Research
-
Mesquite, Texas, United States, 75150
- Southwest Rheumatology Research, LLC
-
San Antonio, Texas, United States, 78215
- Sun Research Institute
-
Stafford, Texas, United States, 77477
- Accurate Clinical Management
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cenerimod 0.5 mg
Participants will receive cenerimod 0.5 mg once daily in addition to background SLE therapy.
Treatment Period 1 is 6 months long.
It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit.
All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 0.5 mg for a further 6 months and end study treatment at the Month 12 visit.
|
Cenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg
|
|
Experimental: Cenerimod 1 mg
Participants will receive cenerimod 1 mg once daily in addition to background SLE therapy.
Treatment Period 1 is 6 months long.
It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit.
All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 1 mg for a further 6 months and end study treatment at the Month 12 visit.
|
Cenerimod will be supplied as a film-coated tablets at the dose of 1 mg
|
|
Experimental: Cenerimod 2 mg
Participants will receive cenerimod 2 mg once daily in addition to background SLE therapy.
Treatment Period 1 is 6 months long.
It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit.
All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 2 mg for a further 6 months and end study treatment at the Month 12 visit.
|
Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg
|
|
Experimental: Cenerimod 2 mg (Ex-4mg)
Half the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.
|
Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg
|
|
Placebo Comparator: Placebo (Ex-4mg)
Half the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to placebo (matching cenerimod) once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.
|
Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod
|
|
Experimental: Cenerimod 4 mg
Participants will received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1.
The participants randomized to the 4 mg treatment who were still on treatment at Month 6 were re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2. The participants who did not complete 6 months of cenerimod 4 mg treatment will be analyzed in the "Non Re-randomized (Ex-4mg)" treatment group.
|
Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg
|
|
Placebo Comparator: Placebo
Participants will receive placebo (matching cenerimod) once daily in addition to background SLE therapy.
Treatment Period 1 is 6 months long.
It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit.
All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with placebo (matching cenerimod) for a further 6 months and end study treatment at the Month 12 visit.
|
Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score
Time Frame: Baseline (Day 1) and Month 6
|
The primary endpoint is the absolute change from baseline in the modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) score.
The SLEDAI-2K is a cumulative index of lupus disease activity scored by the physician.
It is calculated from 24 individual descriptors across 9 organ systems, with weighted scores of 2-8, and measures disease activity within the last 10 days.
0 points indicates inactive disease, and 105 points is the maximum possible score.
In this study the SLEDAI-2K was modified, to exclude leucopenia (minus 1 point), due to the mechanism of action of cenerimod.
Improvement in systemic lupus erythematosus disease activity is defined as a reduction in SLEDAI-2K score of greater than or equal to 4. A decreased score, i.e., a negative change, indicates an improvement in systemic lupus erythematosus disease activity from baseline to Month 6.
|
Baseline (Day 1) and Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline
Time Frame: Baseline (Day 1) and Month 6
|
A responder could only be assessed if the full information of all body systems was available. A participant was defined as a responder based on the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) was a composite, binary endpoint based on three variables:
If one of the SRI-4 mSLEDAI-2K, PGA and BILAG variables were not met the subject was scored a non-responder. Participants that did not fit at least one of the above criteria were assigned to the missing group. |
Baseline (Day 1) and Month 6
|
|
British Isles Lupus Assessment Group-2004 (BILAG) Disease Activity Index Response at Month 6
Time Frame: Baseline (Day 1) and Month 6
|
The British Isles Lupus Assessment Group-2004 (BILAG) is a comprehensive tool used by the physician to assess disease activity and is sensitive to small changes over time. Response (no worsening) at Month 6 on BILAG-2004 disease activity index was defined as no new BILAG A organ domain score and no more than one new BILAG B organ domain score compared with baseline. No analysis is reported because the model did not meet the convergence criteria. |
Baseline (Day 1) and Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Viatris Innovation GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Suffiotti M, Brazauskas P, Keller MP, Berkani O, Seifer G, Cornelisse P, Murphy MJ, Strasser DS. Pharmacodynamics of the S1P1 receptor modulator cenerimod in a phase 2b randomised clinical trial in patients with moderate to severe SLE. Ann Rheum Dis. 2025 Feb;84(2):284-293. doi: 10.1136/ard-2024-226547. Epub 2025 Jan 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2018
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
August 25, 2022
Study Registration Dates
First Submitted
November 12, 2018
First Submitted That Met QC Criteria
November 12, 2018
First Posted (Actual)
November 15, 2018
Study Record Updates
Last Update Posted (Actual)
July 29, 2026
Last Update Submitted That Met QC Criteria
July 13, 2026
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-064A202
- 2018-001808-11 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.