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
3 other identifiers
interventional
470
17 countries
198
Brief 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.
- 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 Dec 2022
Typical duration for phase_3
198 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 13, 2022
CompletedStudy Start
First participant enrolled
December 13, 2022
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
May 6, 2026
August 1, 2025
3.9 years
December 5, 2022
May 5, 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.
Matching 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 (198)
California Research Institute
Huntington Park, California, 90255, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Omega Research MetroWest, LLC
DeBary, Florida, 32713, United States
Alloy Clinical Research, LLC
Kissimmee, Florida, 34741, United States
SouthCoast Research Center, Inc.
Miami, Florida, 33136, United States
Allied Biomedical Research Institute
Miami, Florida, 33155, United States
Professional research Center INC
Miami, Florida, 33172, United States
IRIS Research and Development, LLC
Plantation, Florida, 33324-2736, United States
Augusta University
Augusta, Georgia, 30912, United States
Advance Quality Medical Research
Orland Park, Illinois, 60462, United States
Accurate Clinical Research Inc. - Lake Charles
Lake Charles, Louisiana, 70605, United States
Louisiana State University School of Medicine section of Rheumatology
New Orleans, Louisiana, 70112, United States
Axon Clinical Research -Baltimore
Baltimore, Maryland, 21237, United States
Bronx Care Health and Wellness Center
The Bronx, New York, 10457, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73117, United States
Accurate Clinical Research Inc.
Baytown, Texas, 77521, United States
Rheumatology Care Center, PLLC
Bellaire, Texas, 77041, United States
Houston MD Medspa and Wellness Clinic
Houston, Texas, 77084, United States
Accurate Clinical Research Inc.
Houston, Texas, 77089, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Fundación Respirar
Buenos Aires, 1426, Argentina
Instituto Medico CER
Buenos Aires, B1878DVB, Argentina
Aprillus Asistencia e Investigacion
Buenos Aires, C1046AGA, Argentina
Arsema Clinica Adventista Belgrano
Buenos Aires, C1430EGF, Argentina
IR Medical Center /Hospital de Día/ Instituto de Reumatología y Traumatología
Mendoza, M5500CPH, Argentina
Instituto CAICI SRL
Rosario, S2000PBJ, Argentina
Centro de investigaciones medicas Tucuman
San Miguel de Tucumán, T4000AXL, Argentina
Centro Integral de Reumatología
San Miguel de Tucumán, T4000DVB, Argentina
ICT (Investigaciones Clínicas Tucumán)
San Miguel de Tucumán, T4000ICL, Argentina
Santa Casa de Belo Horizonte
Belo Horizonte, 30150-320, Brazil
Centro Mineiro de Pesquisas
Juiz de Fora, 36010-570, Brazil
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, 99010-120, Brazil
Centro Multidisciplinar de Pesquisa Clínica (Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170, Brazil
LMK Servicos Medico S/S
Porto Alegre, 90480, Brazil
IMPAR SERVICOS HOSPITALARES S/A ; Hospital São Lucas
Rio de Janeiro, 22061-080, Brazil
SER - Serviços Especializados em Reumatologia da Bahia
Salvador, 40150-150, Brazil
Hospital de Clínicas de Porto Alegre
Santa Cecília, 90035-903, Brazil
Centro Multidiciplinar de Estudos Clínicos- CEMEC
São Bernardo do Campo, 09715-090, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090-000, Brazil
CPClin - Centro de Pesquisas Clínicas
São Paulo, 01228-200, Brazil
Ebserh Hospital de Clínicas da Universidade Federal de Uberlândia-HC-UFU
Uberlândia, 38402-028, Brazil
University Multi-profile Hospital for Active Treatment - Plovdiv AD
Plovdiv, 4001, Bulgaria
"University Multiprofile Hospital for Active Treatment - Pulmed" OOD
Plovdiv, 4002, Bulgaria
Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.
Plovdiv, 4004, Bulgaria
DCC-1-Sevlievo EOOD
Sevlievo, 5400, Bulgaria
DCC "Sveta Anna" EOOD
Sofia, 1750, Bulgaria
Acibadem City Clinic Diagnostic-Consultative Center" EOOD, 127 Okolovrasten pat, Mladost
Sofia, 1784, Bulgaria
DCC Equita EOOD
Varna, 9000, Bulgaria
Clínica de la costa Ltda.
Barranquilla, 080020, Colombia
Bluecare salud SAS
Bogotá, 110221, Colombia
IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)
Bogotá, 110221, Colombia
SERVIMED S.A.S Bucaramanga
Bucaramanga, 680003, Colombia
Fundación Valle de Lili
Cali, 760032, Colombia
Centro de Estudios de Reumatología y Dermatología
Cali, 760042, Colombia
Preventive Care SAS
Chía, 250001, Colombia
Hospital Pablo Tobón Uribe
Medellín, 050034, Colombia
Healthy Medical Center SAS
Zipaquirá, 250252, Colombia
Hôpital Pitié-Salpêtrière
Paris, 75013, France
CHU Félix Guyon Site Nord
Saint-Denis, 97400, France
CHU de Purpan
Toulouse, 31059, France
Naval Hospital of Athens
Athens, 115 21, Greece
General Hospital of Athens "Hippokration"
Athens, 11527, Greece
General Hospital of Athens "Laiko"
Athens, 11527, Greece
University General Hospital "Attikon"
Athens, 124 62, Greece
General University Hospital of Larissa
Larissa, 41110, Greece
General University Hospital of Patras
Pátrai, 26504, Greece
Euromedica - Kyanos Stavros
Thessaloniki, 546 36, Greece
General Hospital of Thessaloniki "Hippokration"
Thessaloniki, 546 42, Greece
424 General Military Hospital
Thessaloniki, 56429, Greece
Sangini Hospital
Ahmedabad, 380015, India
ChanRe Rheumatology and Immunology Centre and Research
Bangalore, 560010, India
Rajiv Gandhi Government General Hospital
Chennai, 600003, India
Nizam's Institute of medical Sciences
Hyderabad, 500082, India
Maharaja Agrasen Superspeciality Hospital
Jaipur, 302039, India
Radiance Hospital
Nagpur, 380009, India
Shree Hospital and Critical Care Centre.
Nagpur, 440009, India
Assured Care Plus Hospital
Nashik, 422101, India
Coherence Pain & Arthritis Clinics
Pune, 411001, India
Vijaya Ortho & Trauma Centre
Sadashivnagar, 590001, India
Unity Hospital and Trauma Centre
Surat, 395010, India
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki-shi, 660-8550, Japan
The University of Tokyo Hospital
Bunkyō City, 113-8655, Japan
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chiba, 260-8712, Japan
University of Yamanashi Hospital
Chuo-shi, 409-3898, Japan
St.Luke's International Hospital
Chūōku, 104-8560, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Hiroshima Prefectural Hospital
Hiroshima, 734-8530, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Hitachi, Ltd. Hitachinaka General Hospital
Hitachi-Naka, 312-0057, Japan
National Kohnodai Medical Center, Japan Institute for Health Security
Ichikawa-shi, 272-8516, Japan
Tokai University Hospital
Isehara-shi, 259-1193, Japan
Kakogawa Central City Hospital
Kakogawa-shi, 675-8611, Japan
Shin-Kokura Hospital
Kitakyushu-shi, 803-8505, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
Kuwana City Medical Center
Kuwana-shi, 511-0061, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, 152-8902, Japan
Toho University - Ohashi Medical Center
Meguro-ku, 153-8515, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Chubu Rosai Hospital
Nagoya, 455-8530, Japan
Chukyo Hospital
Nagoya, 457-8510, Japan
Nagoya City University Hospital
Nagoya, 467-8602, Japan
IUHW Narita Hospital
Narita-shi, 286-8520, Japan
Niigata University Medical and Dental Hospital
Niigata, 951-8520, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, 700-8557, Japan
Ome Medical Center
Ome-shi, 198-0042, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, 530-0012, Japan
Toho University Omori Medical Center
Ōta-ku, 143-8541, Japan
Saga University Hospital
Saga, 849-8501, Japan
Japanese Red Cross Saitama Hospital
Saitama-shi, 330-8553, Japan
Sainokuni Higashiomiya Medical Center
Saitama-shi, 331-8577, Japan
Toho University Sakura Medical Center
Sakura-shi, 285-8741, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
National Hospital Organization Hokkaido Medical Center
Sapporo, 063-0005, Japan
Tohoku Medical and Pharmaceutical University Hospital
Sendai, 983-8512, Japan
Showa Medical University East Hospital
Shinagawa-ku, 142-0054, Japan
Keio University Hospital
Shinjuku, 160-8582, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666, Japan
Tomakomai City Hospital
Tomakomai-shi, 053-8567, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Juntendo University Urayasu Hospital
Urayasu-shi, 279-0021, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, 231-8682, Japan
University of Fukui Hospital
Yoshida-gun, 910-1193, Japan
Consultorio Privado de Especialidad
Guadalajara, 44650, Mexico
Centro de Estudios de Investigación Básica y Clínica, S.C.
Guadalajara, 44690, Mexico
Consultorio Médico de Reumatología - Hospital Aranda de la Parra
León, 37000, Mexico
Biológicos Especializados S.A. de C.V.
Mexico City, 06700, Mexico
CITER, Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
Mexico City, 06700, Mexico
Unidad de Atención Médica e Investigación en Salud
Mérida, 97000, Mexico
Centro de Investigación Clínica Chapultepec S. A. de C. V.
Morelia, 58260, Mexico
SMIQ, S. de R.L. de C.V.
Querétaro, 76070, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí City, 78200, Mexico
Unidad de Investigaciones Reumatológicas A.C
San Luis Potosí City, 78290, Mexico
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, 45070, Mexico
Chong-Hua Hospital
Cebu City, 6000, Philippines
Davao Doctors Hospital
Davao City, 8000, Philippines
Mary Mediatrix Medical Center
Lipa, 4217, Philippines
Makati Medical Center
Makati, 1229, Philippines
UP-PGH
Manila, 1000, Philippines
Far Eastern University - Nicanor Reyes Medical Foundation
Quezon City, 1118, Philippines
Jose R. Reyes Memorial Medical Center
Santa Cruz, 1003/1014, Philippines
INTER CLINIC Piotr Adrian Klimiuk
Bialystok, 15-077, Poland
Centrum Medyczne Pratia Częstochowa
Częstochowa, 42-200, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
Vita Longa Sp. z o.o.
Katowice, 40-748, Poland
Małopolskie Badania Kliniczne
Krakow, 30-002, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Velocity Nova Sp. z o. o.
Lublin, 20-362, Poland
Zespół Poradni Specjalistycznych REUMED
Lublin, 20-607, Poland
Malwa-Med Iwona Chlebicka
Wroclaw, 50-304, Poland
Neomed Brasov
Brasov, 500285, Romania
Delta Health Care SRL
Bucharest, 14142, Romania
Spitalul Clinic Judetean de Urgentã Craiova
Craiova, 200642, Romania
SC Medaudio-Optica SRL
Râmnicu Vâlcea, 240762, Romania
Pusan National University Hospital
Busan, 49241, South Korea
Catholic University of Daegu (Daegu Catholic University Medical Center)
Daegu, 42472, South Korea
Seoul National University Hospital
Junggu, 03080, South Korea
Hanyang University Hospital, Seongdong-gu
Seoul, 04763, South Korea
Ewha University Mokdong Hospital, Yangcheon-gu
Seoul, 07985, South Korea
KonKuk University Medical Center, Gwangjin-gu
Seoul, 5030, South Korea
Seoul Saint Mary's Hospital of the Catholic University of Korea, Seocho-gu
Seoul, 6591, South Korea
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Chi Mei Medical Center
Tainan, 71004, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Cheng Hsin General Hospital
Taipei, 112, Taiwan
TRI-Service General Hospital
Taipei, 114, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan City, 33305, Taiwan
Vajira Hospital
Bangkok, 10300, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Phramongkutklao Hospital (PMK)
Bangkok, 10400, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology
Chiang Mai, 50200, Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Fort Sunpasithiprasong Hospital
Ubon Ratchathani, 34190, Thailand
Communal Non-Commercial Enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"
Cherkasy, 18009, Ukraine
Communal Non-Commercial Enterprise "Khmelnytsky Regional Hospital" of Khmelnytsky Regional Council
Khmelnytskyi, 29000, Ukraine
Clinic of Modern Rheumatology
Kyiv, 02081, Ukraine
Kyiv City Clinical Hospital #3
Kyiv, 02125, Ukraine
Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of Joint-Stock Company "Ukrainian Railway"
Kyiv, 03049, Ukraine
State Ins Nat Scie Cen M.D.Strazhesko Ins of Cardio Clin
Kyiv, 03151, Ukraine
Communal Non-Commercial Enterprise of Kyiv Regional Council Kyiv Clinical Regional Hospital, Consultation and Diagnostic Center
Kyiv, 04106, Ukraine
Volyn Regional Clinical Hospital
Lutsk, 43000, Ukraine
Com Non-Com Entr of Lviv Reg Coun "Lviv Reg Clin Hos, Rheu Dprt, Danylo Halytsky Lviv Nat Med Uni
Lviv, 79010, Ukraine
Medical Center of Limited Liability Company "Kalyna. Center of Modern Medicine
Lviv, 79034, Ukraine
Medical Centre "Academical Medical Group" LLC
Lviv, 79044, Ukraine
Uzhhorod City Multidisciplinary Clinical Hospital
Uzhhorod, 88000, Ukraine
Private Small-Scale Enterprise Medical Centre "Pulse", Therapeutical Department
Vinnytsia, 21001, Ukraine
Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital #1"
Vinnytsia, 21029, Ukraine
Communal Enterprise "Hospital #1" of Zhytomyr City Council, Consultation and Treatment Department "Scientific Research Center"
Zhytomyr, 10002, Ukraine
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
December 5, 2022
First Posted
December 13, 2022
Study Start
December 13, 2022
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
May 6, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share