A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus (OPUS-1)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: Cenerimod; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 470
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B1878DVB
    • Instituto Medico CER
  • Buenos Aires, Argentina, 1426
    • Fundación Respirar
  • Buenos Aires, Argentina, C1046AGA
    • APRILLUS Asistencia e Investigacion
  • Buenos Aires, Argentina, C1430EGF
    • Arsema Clinica Adventista Belgrano
  • Mendoza, Argentina, M5500CPH
    • IR Medical Center /Hospital de Día/ Instituto de Reumatología y Traumatología
  • Rosario, Argentina, S2000PBJ
    • Instituto CAICI SRL
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro de Investigaciones Medicas Tucuman
  • San Miguel de Tucumán, Argentina, T4000ICL
    • ICT (Investigaciones Clínicas Tucumán)
  • San Miguel de Tucumán, Argentina, T4000DVB
    • Centro Integral de Reumatología
• Brazil
  • Belo Horizonte, Brazil, 30150-320
    • Santa Casa de Belo Horizonte
  • Juiz de Fora, Brazil, 36010-570
    • Centro Mineiro de Pesquisas
  • Passo Fundo, Brazil, 99010-120
    • Instituto Mederi de Pesquisa e Saude
  • Porto Alegre, Brazil, 90050-170
    • Centro Multidisciplinar de Pesquisa Clínica (Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Porto Alegre, Brazil, 90480
    • LMK Servicos Medico S/S
  • Rio de Janeiro, Brazil, 22061-080
    • IMPAR SERVICOS HOSPITALARES S/A ; Hospital São Lucas
  • Salvador, Brazil, 40150-150
    • SER - Servicos Especializados em Reumatologia da Bahia
  • Santa Cecília, Brazil, 90035-903
    • Hospital De Clinicas De Porto Alegre
  • São Bernardo do Campo, Brazil, 09715-090
    • Centro Multidiciplinar de Estudos Clínicos- CEMEC
  • São José do Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  • São Paulo, Brazil, 01228-200
    • CPCLIN - Centro de Pesquisas Clínicas
  • Uberlândia, Brazil, 38402-028
    • Ebserh Hospital de Clínicas da Universidade Federal de Uberlândia-HC-UFU
• Bulgaria
  • Plovdiv, Bulgaria, 4004
    • Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.
  • Plovdiv, Bulgaria, 4001
    • University Multi-profile Hospital for Active Treatment - Plovdiv AD
  • Plovdiv, Bulgaria, 4002
    • "University Multiprofile Hospital for Active Treatment - Pulmed" OOD
  • Sevlievo, Bulgaria, 5400
    • DCC-1-Sevlievo EOOD
  • Sofia, Bulgaria, 1750
    • DCC "Sveta Anna" EOOD
  • Sofia, Bulgaria, 1784
    • Acibadem City Clinic Diagnostic-Consultative Center" EOOD, 127 Okolovrasten pat, Mladost
  • Varna, Bulgaria, 9000
    • DCC Equita EOOD
• Colombia
  • Barranquilla, Colombia, 080020
    • Clínica de la costa Ltda.
  • Bogotá, Colombia, 110221
    • Bluecare salud SAS
  • Bogotá, Colombia, 110221
    • IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)
  • Bucaramanga, Colombia, 680003
    • SERVIMED S.A.S Bucaramanga
  • Cali, Colombia, 760032
    • Fundación Valle de Lili
  • Cali, Colombia, 760042
    • Centro de Estudios de Reumatología y Dermatología
  • Chía, Colombia, 250001
    • Preventive Care SAS
  • Medellín, Colombia, 050034
    • Hospital Pablo Tobon Uribe
  • Zipaquirá, Colombia, 250252
    • Healthy Medical Center SAS
• France
  • Paris, France, 75013
    • Hôpital Pitié-Salpêtrière
  • Saint-Denis, France, 97400
    • CHU Félix Guyon Site Nord
  • Toulouse, France, 31059
    • CHU de Purpan
• Greece
  • Athens, Greece, 11527
    • General Hospital of Athens "Laiko"
  • Athens, Greece, 11527
    • General Hospital of Athens "Hippokration"
  • Athens, Greece, 124 62
    • University General Hospital "Attikon"
  • Athens, Greece, 115 21
    • Naval Hospital of Athens
  • Larissa, Greece, 41110
    • General University Hospital Of Larissa
  • Pátrai, Greece, 26504
    • General University Hospital of Patras
  • Thessaloniki, Greece, 56429
    • 424 General Military Hospital
  • Thessaloniki, Greece, 546 36
    • Euromedica - Kyanos Stavros
  • Thessaloniki, Greece, 546 42
    • General Hospital of Thessaloniki "Hippokration"
• India
  • Ahmedabad, India, 380015
    • Sangini Hospital
  • Bangalore, India, 560010
    • ChanRe Rheumatology and Immunology Centre and Research
  • Chennai, India, 600003
    • Rajiv Gandhi Government General Hospital
  • Hyderabad, India, 500082
    • Nizam's Institute of Medical Sciences
  • Jaipur, India, 302039
    • Maharaja Agrasen Superspeciality Hospital
  • Nagpur, India, 380009
    • Radiance Hospital
  • Nagpur, India, 440009
    • Shree Hospital and Critical Care Centre.
  • Nashik, India, 422101
    • Assured Care Plus Hospital
  • Pune, India, 411001
    • Coherence Pain & Arthritis Clinics
  • Sadashivnagar, India, 590001
    • Vijaya Ortho & Trauma Centre
  • Surat, India, 395010
    • Unity Hospital and Trauma Centre
• Japan
  • Amagasaki-shi, Japan, 660-8550
    • Hyogo Prefectural Amagasaki General Medical Center
  • Bunkyō City, Japan, 113-8655
    • The University of Tokyo Hospital
  • Chiba, Japan, 260-8712
    • National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
  • Chuo-shi, Japan, 409-3898
    • University of Yamanashi Hospital
  • Chūōku, Japan, 104-8560
    • St.Luke's International Hospital
  • Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hiroshima, Japan, 734-8530
    • Hiroshima Prefectural Hospital
  • Hitachi-Naka, Japan, 312-0057
    • Hitachi, Ltd. Hitachinaka General Hospital
  • Ichikawa-shi, Japan, 272-8516
    • National Kohnodai Medical Center, Japan Institute for Health Security
  • Isehara-shi, Japan, 259-1193
    • Tokai University Hospital
  • Kakogawa-shi, Japan, 675-8611
    • Kakogawa Central City Hospital
  • Kitakyushu-shi, Japan, 803-8505
    • Shin-Kokura Hospital
  • Kobe, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Kobe, Japan, 650-0017
    • Kobe University Hospital
  • Kuwana-shi, Japan, 511-0061
    • Kuwana City Medical Center
  • Meguro-ku, Japan, 152-8902
    • National Hospital Organization Tokyo Medical Center
  • Meguro-ku, Japan, 153-8515
    • Toho University - Ohashi Medical Center
  • Miyazaki, Japan, 889-1692
    • University of Miyazaki Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Nagoya, Japan, 467-8602
    • Nagoya City University Hospital
  • Nagoya, Japan, 455-8530
    • Chubu Rosai Hospital
  • Nagoya, Japan, 457-8510
    • Chukyo Hospital
  • Narita-shi, Japan, 286-8520
    • IUHW Narita Hospital
  • Niigata, Japan, 951-8520
    • Niigata University Medical And Dental Hospital
  • Okayama, Japan, 700-8557
    • Okayama City General Medical Center Okayama City Hospital
  • Ome-shi, Japan, 198-0042
    • Ome Medical Center
  • Osaka, Japan, 530-0012
    • Osaka Saiseikai Nakatsu Hospital
  • Saga, Japan, 849-8501
    • Saga University Hospital
  • Saitama-shi, Japan, 330-8553
    • Japanese Red Cross Saitama Hospital
  • Saitama-shi, Japan, 331-8577
    • Sainokuni Higashiomiya Medical Center
  • Sakura-shi, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Sapporo, Japan, 060-8648
    • Hokkaido University Hospital
  • Sapporo, Japan, 063-0005
    • National Hospital Organization Hokkaido Medical Center
  • Sendai, Japan, 983-8512
    • Tohoku Medical And Pharmaceutical University Hospital
  • Shinagawa-ku, Japan, 142-0054
    • Showa Medical University East Hospital
  • Shinjuku, Japan, 160-8582
    • Keio University Hospital
  • Shinjuku-ku, Japan, 162-8666
    • Tokyo Women's Medical University Hospital
  • Tomakomai-shi, Japan, 053-8567
    • Tomakomai City Hospital
  • Toyama, Japan, 930-0194
    • Toyama University Hospital
  • Urayasu-shi, Japan, 279-0021
    • Juntendo University Urayasu Hospital
  • Yokohama, Japan, 231-8682
    • Yokohama City Minato Red Cross Hospital
  • Yoshida-gun, Japan, 910-1193
    • University of Fukui Hospital
  • Ōta-ku, Japan, 143-8541
    • Toho University Omori Medical Center
• Mexico
  • Guadalajara, Mexico, 44690
    • Centro de Estudios de Investigacion Basica y Clinica, S.C.
  • Guadalajara, Mexico, 44650
    • Consultorio Privado de Especialidad
  • León, Mexico, 37000
    • Consultorio Médico de Reumatología - Hospital Aranda de la Parra
  • Mexico City, Mexico, 06700
    • Biológicos Especializados S.A. de C.V.
  • Mexico City, Mexico, 06700
    • CITER, Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
  • Morelia, Mexico, 58260
    • Centro de Investigacion Clinica Chapultepec S. A. de C. V.
  • Mérida, Mexico, 97000
    • Unidad de Atención Médica e Investigación en Salud
  • Querétaro, Mexico, 76070
    • SMIQ, S. de R.L. de C.V.
  • San Luis Potosí City, Mexico, 78200
    • Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
  • San Luis Potosí City, Mexico, 78290
    • Unidad de Investigaciones Reumatológicas A.C
  • Zapopan, Mexico, 45070
    • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
• Philippines
  • Cebu City, Philippines, 6000
    • Chong-Hua Hospital
  • Davao City, Philippines, 8000
    • Davao Doctors Hospital
  • Lipa, Philippines, 4217
    • Mary Mediatrix Medical Center
  • Makati, Philippines, 1229
    • Makati Medical Center
  • Manila, Philippines, 1000
    • UP-PGH
  • Quezon City, Philippines, 1118
    • Far Eastern University - Nicanor Reyes Medical Foundation
  • Santa Cruz, Philippines, 1003/1014
    • Jose R. Reyes Memorial Medical Center
• Poland
  • Bialystok, Poland, 15-077
    • INTER CLINIC Piotr Adrian Klimiuk
  • Częstochowa, Poland, 42-200
    • Centrum Medyczne Pratia Częstochowa
  • Katowice, Poland, 40-748
    • Vita Longa Sp. z o.o.
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Krakow, Poland, 30-363
    • Centrum Medyczne Plejady
  • Krakow, Poland, 30-002
    • Małopolskie Badania Kliniczne
  • Lublin, Poland, 20-362
    • Velocity Nova Sp. z o. o.
  • Lublin, Poland, 20-607
    • Zespół Poradni Specjalistycznych REUMED
  • Wroclaw, Poland, 50-304
    • Malwa-Med Iwona Chlebicka
• Romania
  • Brasov, Romania, 500285
    • Neomed Brasov
  • Bucharest, Romania, 14142
    • Delta Health Care SRL
  • Craiova, Romania, 200642
    • Spitalul Clinic Judetean de Urgenta Craiova
  • Râmnicu Vâlcea, Romania, 240762
    • Sc Medaudio-Optica SRL
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Daegu, South Korea, 42472
    • Catholic University of Daegu (Daegu Catholic University Medical Center)
  • Junggu, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 04763
    • Hanyang University Hospital, Seongdong-gu
  • Seoul, South Korea, 07985
    • Ewha University Mokdong Hospital, Yangcheon-gu
  • Seoul, South Korea, 5030
    • KonKuk University Medical Center, Gwangjin-gu
  • Seoul, South Korea, 6591
    • Seoul Saint Mary's Hospital of the Catholic University of Korea, Seocho-gu
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Hospital
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Tainan, Taiwan, 71004
    • Chi Mei Medical Center
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
  • Taipei, Taiwan, 112
    • Cheng Hsin General Hospital
  • Taoyuan City, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Bangkok, Thailand, 10300
    • Vajira Hospital
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital (PMK)
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital, Khon Kaen University
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital
  • Ubon Ratchathani, Thailand, 34190
    • Fort Sunpasithiprasong Hospital
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Communal Non-Commercial Enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"
  • Khmelnytskyi, Ukraine, 29000
    • Communal Non-Commercial Enterprise "Khmelnytsky Regional Hospital" of Khmelnytsky Regional Council
  • Kyiv, Ukraine, 02125
    • Kyiv City Clinical Hospital #3
  • Kyiv, Ukraine, 02081
    • Clinic of Modern Rheumatology
  • Kyiv, Ukraine, 03049
    • Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of Joint-Stock Company "Ukrainian Railway"
  • Kyiv, Ukraine, 03151
    • State Ins Nat Scie Cen M.D.Strazhesko Ins of Cardio Clin
  • Kyiv, Ukraine, 04106
    • Communal Non-Commercial Enterprise of Kyiv Regional Council Kyiv Clinical Regional Hospital, Consultation and Diagnostic Center
  • Lutsk, Ukraine, 43000
    • Volyn Regional Clinical Hospital
  • Lviv, Ukraine, 79010
    • Com Non-Com Entr of Lviv Reg Coun "Lviv Reg Clin Hos, Rheu Dprt, Danylo Halytsky Lviv Nat Med Uni
  • Lviv, Ukraine, 79034
    • Medical Center of Limited Liability Company "Kalyna. Center of Modern Medicine
  • Lviv, Ukraine, 79044
    • Medical Centre "Academical Medical Group" LLC
  • Uzhhorod, Ukraine, 88000
    • Uzhhorod City Multidisciplinary Clinical Hospital
  • Vinnytsia, Ukraine, 21001
    • Private Small-Scale Enterprise Medical Centre "Pulse", Therapeutical Department
  • Vinnytsia, Ukraine, 21029
    • Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital #1"
  • Zhytomyr, Ukraine, 10002
    • Communal Enterprise "Hospital #1" of Zhytomyr City Council, Consultation and Treatment Department "Scientific Research Center"
• United States
  • California
    • Huntington Park, California, United States, 90255
      • California Research Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • DeBary, Florida, United States, 32713
      • Omega Research MetroWest, LLC
    • Kissimmee, Florida, United States, 34741
      • Alloy Clinical Research, LLC
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research Institute
    • Miami, Florida, United States, 33136
      • SouthCoast Research Center, Inc.
    • Miami, Florida, United States, 33172
      • Professional Research Center Inc
    • Plantation, Florida, United States, 33324-2736
      • IRIS Research and Development, LLC
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Illinois
    • Orland Park, Illinois, United States, 60462
      • Advance Quality Medical Research
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Accurate Clinical Research Inc. - Lake Charles
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University School of Medicine section of Rheumatology
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Axon Clinical Research -Baltimore
  • New York
    • The Bronx, New York, United States, 10457
      • Bronx Care Health and Wellness Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research, PLLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • University of Oklahoma College of Medicine
  • Texas
    • Baytown, Texas, United States, 77521
      • Accurate Clinical Research Inc.
    • Bellaire, Texas, United States, 77041
      • Rheumatology Care Center, PLLC
    • Houston, Texas, United States, 77089
      • Accurate Clinical Research Inc.
    • Houston, Texas, United States, 77084
      • Houston MD Medspa and Wellness Clinic
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cenerimod 4 mg; Participants will receive cenerimod once daily in addition to background SLE therapy.	Drug: Cenerimod; Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.; Other Names: ACT-334441
Placebo Comparator: Matching placebo; Participants will receive matching placebo once daily in addition to background SLE therapy.	Drug: Placebo; 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response	A response is defined as a reduction of at least 4 points from baseline.	Day 1 (pre-dose baseline) to Month 12
Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline	Response on BICLA is defined as: Improvement from baseline in disease activity as measured by BILAG. Improvement is defined as a reduction of all baseline BILAG A to B/C/D and baseline BILAG B to C/D and no BILAG worsening in other organ systems, where worsening is defined as ≥ 1 new BILAG A or ≥ 2 new BILAG B, and; No worsening from baseline in mSLEDAI-2K, where worsening is defined as an increase from baseline of > 0 points in mSLEDAI-2K, and; No worsening from baseline in the patient's lupus disease activity, where worsening is defined as an increase of ≥ 0.30 points on a 3-point PGA VAS, and; No discontinuation of investigational product, and; No violation of specified medication rules detailed in the core protocol.	At Month 12 compared to Day 1 (pre-dose baseline)
Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations (i.e., rash, alopecia, mucosal ulcers)	Response is defined as: No increase in the overall mSLEDAI-2K score excluding mucocutaneous manifestations, and; Remission (score of zero) from baseline in the mSLEDAI 2K score of mucocutaneous manifestations.	Day 1 (pre-dose baseline) to Month 12

Collaborators and Investigators

• Sponsor: Viatris Innovation GmbH
• Investigators: Study Director: Clinical Trials, Viatris Innovation GmbH

Publications and helpful links

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.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Immune System Diseases; Connective Tissue Diseases; Autoimmune Diseases; Musculoskeletal and connective tissue disorders
• Additional Relevant MeSH Terms: Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases; cenerimod
• Other Study ID Numbers: ID-064A301; 2022-002814-17 (EudraCT Number); 2024-515870-28-00 (Ctis)

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
• product manufactured in and exported from the U.S.: No