AzTrials
AzTrials

Lupus Erythematosus, SystemicPhase 3OPUS-1NCT05648500

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

A Phase 3 study testing Cenerimod in people with Lupus Erythematosus, Systemic, run by Viatris Innovation GmbH at 198 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Cenerimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
470 participants
Where
198 sitesin 17 countries
Study dates
13 Dec 2022to 30 Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • 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.

Who cannot join

None listed.

Trial locations and contacts

198 sites in 17 countries.

198 sites in 17 countries

Japan44 sites

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki-shi, 660-8550

  • The University of Tokyo Hospital

    Bunkyō City, 113-8655

  • National Hospital Organization Chiba Medical Center Chibahigashi National Hospital

    Chiba, 260-8712

  • University of Yamanashi Hospital

    Chuo-shi, 409-3898

  • St.Luke's International Hospital

    Chūōku, 104-8560

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Hitachi, Ltd. Hitachinaka General Hospital

    Hitachi-Naka, 312-0057

  • National Kohnodai Medical Center, Japan Institute for Health Security

    Ichikawa-shi, 272-8516

  • Tokai University Hospital

    Isehara-shi, 259-1193

  • Kakogawa Central City Hospital

    Kakogawa-shi, 675-8611

  • Shin-Kokura Hospital

    Kitakyushu-shi, 803-8505

  • Kobe University Hospital

    Kobe, 650-0017

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • Kuwana City Medical Center

    Kuwana-shi, 511-0061

  • National Hospital Organization Tokyo Medical Center

    Meguro-ku, 152-8902

  • Toho University - Ohashi Medical Center

    Meguro-ku, 153-8515

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Chubu Rosai Hospital

    Nagoya, 455-8530

  • Chukyo Hospital

    Nagoya, 457-8510

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • IUHW Narita Hospital

    Narita-shi, 286-8520

  • Niigata University Medical and Dental Hospital

    Niigata, 951-8520

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700-8557

  • Ome Medical Center

    Ome-shi, 198-0042

  • Osaka Saiseikai Nakatsu Hospital

    Osaka, 530-0012

  • Toho University Omori Medical Center

    Ōta-ku, 143-8541

  • Saga University Hospital

    Saga, 849-8501

  • Japanese Red Cross Saitama Hospital

    Saitama-shi, 330-8553

  • Sainokuni Higashiomiya Medical Center

    Saitama-shi, 331-8577

  • Toho University Sakura Medical Center

    Sakura-shi, 285-8741

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • National Hospital Organization Hokkaido Medical Center

    Sapporo, 063-0005

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, 983-8512

  • Showa Medical University East Hospital

    Shinagawa-ku, 142-0054

  • Keio University Hospital

    Shinjuku, 160-8582

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, 162-8666

  • Tomakomai City Hospital

    Tomakomai-shi, 053-8567

  • Toyama University Hospital

    Toyama, 930-0194

  • Juntendo University Urayasu Hospital

    Urayasu-shi, 279-0021

  • Yokohama City Minato Red Cross Hospital

    Yokohama, 231-8682

  • University of Fukui Hospital

    Yoshida-gun, 910-1193

Other trials in Japan

United States22 sites

  • Augusta University

    Augusta, Georgia, 30912

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Axon Clinical Research -Baltimore

    Baltimore, Maryland, 21237

  • Accurate Clinical Research Inc.

    Baytown, Texas, 77521

  • Rheumatology Care Center, PLLC

    Bellaire, Texas, 77041

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Omega Research MetroWest, LLC

    DeBary, Florida, 32713

  • Houston MD Medspa and Wellness Clinic

    Houston, Texas, 77084

  • Accurate Clinical Research Inc.

    Houston, Texas, 77089

  • California Research Institute

    Huntington Park, California, 90255

  • Alloy Clinical Research, LLC

    Kissimmee, Florida, 34741

  • Accurate Clinical Research Inc. - Lake Charles

    Lake Charles, Louisiana, 70605

  • SouthCoast Research Center, Inc.

    Miami, Florida, 33136

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • Professional research Center INC

    Miami, Florida, 33172

  • Louisiana State University School of Medicine section of Rheumatology

    New Orleans, Louisiana, 70112

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73117

  • Advance Quality Medical Research

    Orland Park, Illinois, 60462

  • IRIS Research and Development, LLC

    Plantation, Florida, 33324-2736

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Bronx Care Health and Wellness Center

    The Bronx, New York, 10457

Other trials in United States

Ukraine15 sites

  • Communal Non-Commercial Enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"

    Cherkasy, 18009

  • Communal Non-Commercial Enterprise "Khmelnytsky Regional Hospital" of Khmelnytsky Regional Council

    Khmelnytskyi, 29000

  • Clinic of Modern Rheumatology

    Kyiv, 02081

  • Kyiv City Clinical Hospital #3

    Kyiv, 02125

  • Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of Joint-Stock Company "Ukrainian Railway"

    Kyiv, 03049

  • State Ins Nat Scie Cen M.D.Strazhesko Ins of Cardio Clin

    Kyiv, 03151

  • Communal Non-Commercial Enterprise of Kyiv Regional Council Kyiv Clinical Regional Hospital, Consultation and Diagnostic Center

    Kyiv, 04106

  • Volyn Regional Clinical Hospital

    Lutsk, 43000

  • Com Non-Com Entr of Lviv Reg Coun "Lviv Reg Clin Hos, Rheu Dprt, Danylo Halytsky Lviv Nat Med Uni

    Lviv, 79010

  • Medical Center of Limited Liability Company "Kalyna. Center of Modern Medicine

    Lviv, 79034

  • Medical Centre "Academical Medical Group" LLC

    Lviv, 79044

  • Uzhhorod City Multidisciplinary Clinical Hospital

    Uzhhorod, 88000

  • Private Small-Scale Enterprise Medical Centre "Pulse", Therapeutical Department

    Vinnytsia, 21001

  • Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital #1"

    Vinnytsia, 21029

  • Communal Enterprise "Hospital #1" of Zhytomyr City Council, Consultation and Treatment Department "Scientific Research Center"

    Zhytomyr, 10002

Other trials in Ukraine

Brazil12 sites

  • Santa Casa de Belo Horizonte

    Belo Horizonte, 30150-320

  • Centro Mineiro de Pesquisas

    Juiz de Fora, 36010-570

  • Instituto Méderi de Pesquisa e Saúde

    Passo Fundo, 99010-120

  • Centro Multidisciplinar de Pesquisa Clínica (Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90050-170

  • LMK Servicos Medico S/S

    Porto Alegre, 90480

  • IMPAR SERVICOS HOSPITALARES S/A ; Hospital São Lucas

    Rio de Janeiro, 22061-080

  • SER - Serviços Especializados em Reumatologia da Bahia

    Salvador, 40150-150

  • Hospital de Clínicas de Porto Alegre

    Santa Cecília, 90035-903

  • Centro Multidiciplinar de Estudos Clínicos- CEMEC

    São Bernardo do Campo, 09715-090

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, 15090-000

  • CPClin - Centro de Pesquisas Clínicas

    São Paulo, 01228-200

  • Ebserh Hospital de Clínicas da Universidade Federal de Uberlândia-HC-UFU

    Uberlândia, 38402-028

Other trials in Brazil

India11 sites

  • Sangini Hospital

    Ahmedabad, 380015

  • ChanRe Rheumatology and Immunology Centre and Research

    Bangalore, 560010

  • Rajiv Gandhi Government General Hospital

    Chennai, 600003

  • Nizam's Institute of medical Sciences

    Hyderabad, 500082

  • Maharaja Agrasen Superspeciality Hospital

    Jaipur, 302039

  • Radiance Hospital

    Nagpur, 380009

  • Shree Hospital and Critical Care Centre.

    Nagpur, 440009

  • Assured Care Plus Hospital

    Nashik, 422101

  • Coherence Pain & Arthritis Clinics

    Pune, 411001

  • Vijaya Ortho & Trauma Centre

    Sadashivnagar, 590001

  • Unity Hospital and Trauma Centre

    Surat, 395010

Other trials in India

Mexico11 sites

  • Consultorio Privado de Especialidad

    Guadalajara, 44650

  • Centro de Estudios de Investigación Básica y Clínica, S.C.

    Guadalajara, 44690

  • Consultorio Médico de Reumatología - Hospital Aranda de la Parra

    León, 37000

  • Unidad de Atención Médica e Investigación en Salud

    Mérida, 97000

  • Biológicos Especializados S.A. de C.V.

    Mexico City, 06700

  • CITER, Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.

    Mexico City, 06700

  • Centro de Investigación Clínica Chapultepec S. A. de C. V.

    Morelia, 58260

  • SMIQ, S. de R.L. de C.V.

    Querétaro, 76070

  • Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

    San Luis Potosí City, 78200

  • Unidad de Investigaciones Reumatológicas A.C

    San Luis Potosí City, 78290

  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

    Zapopan, 45070

Other trials in Mexico

Taiwan10 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • China Medical University Hospital

    Taichung, 404

  • Chi Mei Medical Center

    Tainan, 71004

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Medical University Hospital

    Taipei, 110

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Cheng Hsin General Hospital

    Taipei, 112

  • TRI-Service General Hospital

    Taipei, 114

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 33305

Other trials in Taiwan

Argentina9 sites

  • Fundación Respirar

    Buenos Aires, 1426

  • Instituto Medico CER

    Buenos Aires, B1878DVB

  • Aprillus Asistencia e Investigacion

    Buenos Aires, C1046AGA

  • Arsema Clinica Adventista Belgrano

    Buenos Aires, C1430EGF

  • IR Medical Center /Hospital de Día/ Instituto de Reumatología y Traumatología

    Mendoza, M5500CPH

  • Instituto CAICI SRL

    Rosario, S2000PBJ

  • Centro de investigaciones medicas Tucuman

    San Miguel de Tucumán, T4000AXL

  • Centro Integral de Reumatología

    San Miguel de Tucumán, T4000DVB

  • ICT (Investigaciones Clínicas Tucumán)

    San Miguel de Tucumán, T4000ICL

Other trials in Argentina

Colombia9 sites

  • Clínica de la costa Ltda.

    Barranquilla, 080020

  • Bluecare salud SAS

    Bogotá, 110221

  • IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)

    Bogotá, 110221

  • SERVIMED S.A.S Bucaramanga

    Bucaramanga, 680003

  • Fundación Valle de Lili

    Cali, 760032

  • Centro de Estudios de Reumatología y Dermatología

    Cali, 760042

  • Preventive Care SAS

    Chía, 250001

  • Hospital Pablo Tobón Uribe

    Medellín, 050034

  • Healthy Medical Center SAS

    Zipaquirá, 250252

Other trials in Colombia

Greece9 sites

  • Naval Hospital of Athens

    Athens, 115 21

  • General Hospital of Athens "Hippokration"

    Athens, 11527

  • General Hospital of Athens "Laiko"

    Athens, 11527

  • University General Hospital "Attikon"

    Athens, 124 62

  • General University Hospital of Larissa

    Larissa, 41110

  • General University Hospital of Patras

    Pátrai, 26504

  • Euromedica - Kyanos Stavros

    Thessaloniki, 546 36

  • General Hospital of Thessaloniki "Hippokration"

    Thessaloniki, 546 42

  • 424 General Military Hospital

    Thessaloniki, 56429

Other trials in Greece

Poland9 sites

  • INTER CLINIC Piotr Adrian Klimiuk

    Bialystok, 15-077

  • Centrum Medyczne Pratia Częstochowa

    Częstochowa, 42-200

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

  • Małopolskie Badania Kliniczne

    Krakow, 30-002

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Velocity Nova Sp. z o. o.

    Lublin, 20-362

  • Zespół Poradni Specjalistycznych REUMED

    Lublin, 20-607

  • Malwa-Med Iwona Chlebicka

    Wroclaw, 50-304

Other trials in Poland

Thailand9 sites

  • Vajira Hospital

    Bangkok, 10300

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Phramongkutklao Hospital (PMK)

    Bangkok, 10400

  • Rajavithi Hospital

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology

    Chiang Mai, 50200

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002

  • Songklanagarind Hospital

    Songkhla, 90110

  • Fort Sunpasithiprasong Hospital

    Ubon Ratchathani, 34190

Other trials in Thailand

Bulgaria7 sites

  • University Multi-profile Hospital for Active Treatment - Plovdiv AD

    Plovdiv, 4001

  • "University Multiprofile Hospital for Active Treatment - Pulmed" OOD

    Plovdiv, 4002

  • Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.

    Plovdiv, 4004

  • DCC-1-Sevlievo EOOD

    Sevlievo, 5400

  • DCC "Sveta Anna" EOOD

    Sofia, 1750

  • Acibadem City Clinic Diagnostic-Consultative Center" EOOD, 127 Okolovrasten pat, Mladost

    Sofia, 1784

  • DCC Equita EOOD

    Varna, 9000

Other trials in Bulgaria

Philippines7 sites

  • Chong-Hua Hospital

    Cebu City, 6000

  • Davao Doctors Hospital

    Davao City, 8000

  • Mary Mediatrix Medical Center

    Lipa, 4217

  • Makati Medical Center

    Makati, 1229

  • UP-PGH

    Manila, 1000

  • Far Eastern University - Nicanor Reyes Medical Foundation

    Quezon City, 1118

  • Jose R. Reyes Memorial Medical Center

    Santa Cruz, 1003/1014

Other trials in Philippines

South Korea7 sites

  • Pusan National University Hospital

    Busan, 49241

  • Catholic University of Daegu (Daegu Catholic University Medical Center)

    Daegu, 42472

  • Seoul National University Hospital

    Junggu, 03080

  • Hanyang University Hospital, Seongdong-gu

    Seoul, 04763

  • Ewha University Mokdong Hospital, Yangcheon-gu

    Seoul, 07985

  • KonKuk University Medical Center, Gwangjin-gu

    Seoul, 5030

  • Seoul Saint Mary's Hospital of the Catholic University of Korea, Seocho-gu

    Seoul, 6591

Other trials in South Korea

Romania4 sites

  • Neomed Brasov

    Brasov, 500285

  • Delta Health Care SRL

    Bucharest, 14142

  • Spitalul Clinic Judetean de Urgentã Craiova

    Craiova, 200642

  • SC Medaudio-Optica SRL

    Râmnicu Vâlcea, 240762

Other trials in Romania

France3 sites

  • Hôpital Pitié-Salpêtrière

    Paris, 75013

  • CHU Félix Guyon Site Nord

    Saint-Denis, 97400

  • CHU de Purpan

    Toulouse, 31059

Other trials in France

About this study

Official title: 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.

Being tested
Cenerimod, Placebo
Keywords
Musculoskeletal and connective tissue disorders, Connective Tissue Diseases, Immune System Diseases, Autoimmune Diseases
Medical subject headings
Lupus Erythematosus, Systemic, Connective Tissue Diseases, Immune System Diseases, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CenerimodDrug

    Also called ACT-334441

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

  • PlaceboDrug

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

Study groups in NCT05648500
Study groupRoleWhat they receive
Cenerimod 4 mgExperimentalParticipants will receive cenerimod once daily in addition to background SLE therapy.
Receives: Drug: Cenerimod
Matching placeboPlacebo comparatorParticipants will receive matching placebo once daily in addition to background SLE therapy.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Month 12 compared to Day 1 (pre-dose baseline)

Secondary outcomes (4)

  1. 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.

    Measured: At Month 12 compared to Day 1 (pre-dose baseline)

  2. 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.

    Measured: Day 1 (pre-dose baseline) to Month 12

  3. Steroid sparing effect in the subgroup of subjects with baseline OCS dose ≥ 10 mg/day prednisone or equivalent

    Response is defined as meeting all of the following:

    • Achieve an OCS dose of ≤ 7.5 mg/day prednisone or equivalent by Month 9.
    • Maintain an OCS dose ≤ 7.5 mg/day prednisone or equivalent from Month 9 to Month 12.
    • No violation of pre-specified medication rules detailed in the core protocol.

    Measured: Day 1 (pre-dose baseline) to Month 12

  4. Response at Month 12 in Lupus Low Disease Activity State (LLDAS)

    response is defined as:

    • mSLEDAI-2K ≤ 4 (with no activity in major organ systems, i.e., renal, central nervous system, cardiopulmonary, vasculitis and fever).
    • No new features of lupus disease activity compared with the previous assessment.
    • PGA ≤ 1.
    • Current prednisone-equivalent dosage ≤ 7.5 mg/day.
    • Well tolerated standard maintenance dosages of immunosuppressive drugs and approved biologics.

    Measured: Day 1 (pre-dose baseline) to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2022
  2. Study start13 Dec 2022
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05648500
Sponsor's protocol ID
ID-064A301
Other IDs
2022-002814-17, 2024-515870-28-00
Acronym
OPUS-1
Status last verified
Sep 2026
First submitted
5 Dec 2022
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 39586304

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cenerimod in people with Lupus Erythematosus, Systemic, run by Viatris Innovation GmbH at 198 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 79 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in Japan, United States, Ukraine, Brazil, India and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline (time frame: At Month 12 compared to Day 1 (pre-dose baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05648500, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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