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:
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 75 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05648500 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Idorsia Pharmaceuticals Ltd. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Trials |
Principal Investigator Affiliation | Idorsia Pharmaceuticals Ltd. |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Brazil, Bulgaria, Colombia, France, Greece, India, Mexico, Philippines, Poland, Romania, South Korea, Taiwan, Thailand, Ukraine, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Lupus Erythematosus, Systemic |
Experimental: Cenerimod 4 mg
Participants will receive cenerimod once daily in addition to background SLE therapy.
Placebo Comparator: Matching placebo
Participants will receive matching placebo 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.
Drug: - Placebo
Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Withdrawn
Address
Providence Medical Foundation
Fullerton 5351247, California 5332921, 92835
Status
Recruiting
Address
California Research Institute
Huntington Park 5358736, California 5332921, 90255
Status
Recruiting
Address
University of Colorado Denver
Aurora 5412347, Colorado 5417618, 80045
Status
Withdrawn
Address
RASF-Clinical Research Inc.
Boca Raton 4148411, Florida 4155751, 33486
Status
Recruiting
Address
Clinical Research of West Florida, Inc.
Clearwater 4151316, Florida 4155751, 33765
Status
Recruiting
Address
Omega Research MetroWest, LLC
DeBary 4152926, Florida 4155751, 32713
Status
Recruiting
Address
SouthCoast Research Center, Inc.
Miami 4164138, Florida 4155751, 33136
Status
Recruiting
Address
IRIS Research and Development, LLC
Plantation 4168782, Florida 4155751, 33324-2736
Status
Withdrawn
Address
Renew Health Clinical Research LLC
Tampa 4174757, Florida 4155751, 33607
Status
Recruiting
Address
Augusta University
Augusta 4180531, Georgia 4197000, 30912
Status
Recruiting
Address
Advance Quality Medical Research
Orland Park 4904937, Illinois 4896861, 60462
Status
Recruiting
Address
Accurate Clinical Research Inc. - Lake Charles
Lake Charles 4330236, Louisiana 4331987, 70605
Status
Not yet recruiting
Address
Louisiana State University School of Medicine section of Rheumatology
New Orleans 4335045, Louisiana 4331987, 70112
Status
Recruiting
Address
Axon Clinical Research -Baltimore
Baltimore 4347778, Maryland 4361885, 21237
Status
Withdrawn
Address
Klein & Associates, M.D., P.A.
Hagerstown 4357141, Maryland 4361885, 21740
Status
Withdrawn
Address
June DO, PC
Lansing 4998830, Michigan 5001836, 48911
Status
Recruiting
Address
Bronx Care Health and Wellness Center
The Bronx 5110266, New York 5128638, 10457
Status
Recruiting
Address
DJL Clinical Research, PLLC
Charlotte 4460243, North Carolina 4482348, 28210
Status
Recruiting
Address
Superior Clinical Reseach LLC
Smithfield 4492168, North Carolina 4482348, 27577
Status
Not yet recruiting
Address
University of Oklahoma College of Medicine
Oklahoma City 4544349, Oklahoma 4544379, 73117
Status
Withdrawn
Address
Temple University Health Systems/ Lewis Katz School of Medicine
Philadelphia 4560349, Pennsylvania 6254927, 19140
Status
Withdrawn
Address
Shelby Research, LLC
Memphis 4641239, Tennessee 4662168, 38119-5214
Status
Withdrawn
Address
Allen Arthritis
Allen 4670300, Texas 4736286, 75013
Status
Recruiting
Address
Accurate Clinical Research Inc.
Baytown 4672731, Texas 4736286, 77521
Status
Recruiting
Address
Rheumatology Care Center, PLLC
Bellaire 4673353, Texas 4736286, 77041
Status
Withdrawn
Address
Metroplex Clinical Research Center
Dallas 4684888, Texas 4736286, 75231
Status
Recruiting
Address
Houston MD Medspa and Wellness Clinic
Houston 4699066, Texas 4736286, 77084
Status
Recruiting
Address
Accurate Clinical Research Inc.
Houston 4699066, Texas 4736286, 77089
Status
Recruiting
Address
Sun Research Institute
San Antonio 4726206, Texas 4736286, 78215
Status
Recruiting
Address
Fundación Respirar
Buenos Aires 3435910, , 1426
Status
Recruiting
Address
Instituto Medico CER
Buenos Aires 3435910, , B1878DVB
Status
Recruiting
Address
Aprillus Asistencia e Investigacion
Buenos Aires 3435910, , C1046AGA
Status
Recruiting
Address
Hospital Ramos Mejia
Buenos Aires 3435910, , C1221ADC
Status
Recruiting
Address
Arsema Clinica Adventista Belgrano
Buenos Aires 3435910, , C1430EGF
Status
Recruiting
Address
IR Medical Center /Hospital de Día/ Instituto de Reumatología y Traumatología
Mendoza 3844421, , M5500CPH
Status
Recruiting
Address
Instituto CAICI SRL
Rosario 3838583, , S2000PBJ
Status
Recruiting
Address
Centro de investigaciones medicas Tucuman
San Miguel de Tucumán 3836873, , T4000AXL
Status
Recruiting
Address
Centro Integral de Reumatología
San Miguel de Tucumán 3836873, , T4000DVB
Status
Recruiting
Address
ICT (Investigaciones Clínicas Tucumán)
San Miguel de Tucumán 3836873, , T4000ICL
Status
Recruiting
Address
Santa Casa de Belo Horizonte
Belo Horizonte 3470127, , 30150-320
Status
Withdrawn
Address
Hospital Brasília
Brasília 3469058, , 71635-580
Status
Active, not recruiting
Address
Centro Mineiro de Pesquisas
Juiz de Fora 3459505, , 36010-570
Status
Active, not recruiting
Address
Instituto Méderi de Pesquisa e Saúde
Passo Fundo 3454857, , 99010-120
Status
Recruiting
Address
Centro Multidisciplinar de Pesquisa Clínica (Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre 3452925, , 90050-170
Status
Recruiting
Address
LMK Servicos Medico S/S
Porto Alegre 3452925, , 90480
Status
Recruiting
Address
IMPAR SERVICOS HOSPITALARES S/A ; Hospital São Lucas
Rio de Janeiro 3451190, , 22061-080
Status
Recruiting
Address
SER - Serviços Especializados em Reumatologia da Bahia
Salvador 3450554, , 40150-150
Status
Not yet recruiting
Address
Hospital de Clínicas de Porto Alegre
Santa Cecília 3450376, , 90035-903
Status
Not yet recruiting
Address
Centro Multidiciplinar de Estudos Clínicos- CEMEC
São Bernardo do Campo 3449344, , 09715-090
Status
Recruiting
Address
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto 3448639, , 15090-000
Status
Recruiting
Address
CPClin - Centro de Pesquisas Clínicas
São Paulo 3448439, , 01228-200
Status
Recruiting
Address
Ebserh Hospital de Clínicas da Universidade Federal de Uberlândia-HC-UFU
Uberlândia 3445831, , 38402-028
Status
Recruiting
Address
University Multi-profile Hospital for Active Treatment - Plovdiv AD
Plovdiv 728193, , 4001
Status
Recruiting
Address
"University Multiprofile Hospital for Active Treatment - Pulmed" OOD
Plovdiv 728193, , 4002
Status
Recruiting
Address
Medical Center ArtMed OOD
Plovdiv 728193, , 4002
Status
Recruiting
Address
Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.
Plovdiv 728193, , 4004
Status
Recruiting
Address
DCC 1 Ruse
Rousse 727523, , 7000
Status
Not yet recruiting
Address
DCC "Sveta Anna" EOOD
Sofia 727011, , 1750
Status
Recruiting
Address
Acibadem City Clinic Diagnostic-Consultative Center" EOOD, 127 Okolovrasten pat, Mladost
Sofia 727011, , 1784
Status
Recruiting
Address
DCC Equita EOOD
Varna 726050, , 9000
Status
Recruiting
Address
Clínica de la costa Ltda.
Barranquilla 3689147, , 080020
Status
Recruiting
Address
Bluecare salud SAS
Bogotá 3688689, , 110221
Status
Recruiting
Address
IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)
Bogotá 3688689, , 110221
Status
Recruiting
Address
SERVIMED S.A.S Bucaramanga
Bucaramanga 3688465, , 680003
Status
Recruiting
Address
Preventive Care SAS
Chía 3686675, , 250001
Status
Recruiting
Address
Hospital Pablo Tobón Uribe
Medellín 3674962, , 050034
Status
Withdrawn
Address
Fundación Centro De Excelencia En Enfermedades Crónicas No Transmisibles-FUNCENTRA
Montería 3674453, , 230003
Status
Recruiting
Address
Fundación Valle de Lili
Santiago de Cali 3687925, , 760032
Status
Recruiting
Address
Centro de Estudios de Reumatología y Dermatología
Santiago de Cali 3687925, , 760042
Status
Recruiting
Address
Healthy Medical Center SAS
Zipaquirá 3665542, , 250252
Status
Recruiting
Address
Hôpital Pitié-Salpêtrière
Paris 2988507, , 75013
Status
Recruiting
Address
CHU Félix Guyon Site Nord
Saint-Denis 2980916, , 97400
Status
Recruiting
Address
CHU de Purpan
Toulouse 2972315, , 31059
Status
Recruiting
Address
Naval Hospital of Athens
Athens 264371, , 115 21
Status
Recruiting
Address
General Hospital of Athens "Hippokration"
Athens 264371, , 11527
Status
Recruiting
Address
General Hospital of Athens "Laiko"
Athens 264371, , 11527
Status
Recruiting
Address
University General Hospital "Attikon"
Athens 264371, , 124 62
Status
Recruiting
Address
General University Hospital of Larissa
Larissa 258576, , 41110
Status
Recruiting
Address
General University Hospital of Patras
Pátrai 255683, , 26504
Status
Recruiting
Address
Euromedica - Kyanos Stavros
Thessaloniki 734077, , 546 36
Status
Recruiting
Address
General Hospital of Thessaloniki "Hippokration"
Thessaloniki 734077, , 546 42
Status
Recruiting
Address
424 General Military Hospital
Thessaloniki 734077, , 56429
Status
Not yet recruiting
Address
Assured Care Plus Hospital
Maharashtra, , 422101
Status
Withdrawn
Address
Panamerican Clinical Research Mexico S.A. de C.V.
Cuernavaca 3529947, , 62290
Status
Recruiting
Address
Consultorio Privado de Especialidad
Guadalajara 4005539, , 44650
Status
Recruiting
Address
Centro de Estudios de Investigación Básica y Clínica, S.C.
Guadalajara 4005539, , 44690
Status
Active, not recruiting
Address
Consultorio Médico de Reumatología - Hospital Aranda de la Parra
León 3998655, , 37000
Status
Recruiting
Address
Biológicos Especializados S.A. de C.V.
Mexico City 3530597, , 06700
Status
Recruiting
Address
CITER, Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
Mexico City 3530597, , 06700
Status
Recruiting
Address
Unidad de Atención Médica e Investigación en Salud
Mérida 3523349, , 97000
Status
Recruiting
Address
Centro de Investigación Clínica Chapultepec S. A. de C. V.
Morelia 3995402, , 58260
Status
Recruiting
Address
SMIQ, S. de R.L. de C.V.
Querétaro 3816887, , 76070
Status
Recruiting
Address
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí City 3985606, , 78200
Status
Not yet recruiting
Address
Unidad de Investigaciones Reumatológicas A.C
San Luis Potosí City 3985606, , 78290
Status
Recruiting
Address
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan 3979770, , 45070
Status
Recruiting
Address
Chong-Hua Hospital
Cebu City 1717512, , 6000
Status
Recruiting
Address
Davao Doctors Hospital
Davao City 1715348, , 8000
Status
Recruiting
Address
Mary Mediatrix Medical Center
Lipa 1706091, , 4217
Status
Recruiting
Address
Makati Medical Center
Makati 1703414, , 1229
Status
Recruiting
Address
UP-PGH
Manila 1701668, , 1000
Status
Recruiting
Address
Far Eastern University - Nicanor Reyes Medical Foundation
Quezon City 1692192, , 1118
Status
Recruiting
Address
Jose R. Reyes Memorial Medical Center
Santa Cruz 1688216, , 1003/1014
Status
Recruiting
Address
Centrum Medyczne Pratia Częstochowa
Częstochowa 3100946, , 42-200
Status
Recruiting
Address
Centrum Medyczne Angelius Provita
Katowice 3096472, , 40-611
Status
Recruiting
Address
Vita Longa Sp. z o.o.
Katowice 3096472, , 40-748
Status
Recruiting
Address
Małopolskie Badania Kliniczne
Krakow 3094802, , 30-002
Status
Recruiting
Address
Centrum Medyczne Plejady
Krakow 3094802, , 30-363
Status
Recruiting
Address
Zespół Poradni Specjalistycznych REUMED
Lublin 765876, , 20-607
Status
Recruiting
Address
Malwa-Med Iwona Chlebicka
Wroclaw 3081368, , 50-304
Status
Recruiting
Address
Neomed Brasov
Brasov 683844, , 500285
Status
Withdrawn
Address
SC Sana Monitoring SRL
Bucharest 683506, , 11025
Status
Recruiting
Address
Delta Health Care SRL
Bucharest 683506, , 14142
Status
Withdrawn
Address
Spitalul Clinic Dr. Ion Cantacuzino
Bucharest 683506, , 30167
Status
Recruiting
Address
Spitalul Clinic Judetean de Urgentã Craiova
Craiova 680332, , 200642
Status
Recruiting
Address
SC Medaudio-Optica SRL
Râmnicu Vâlcea 668872, , 240762
Status
Recruiting
Address
Pusan National University Hospital
Busan 1838524, , 49241
Status
Active, not recruiting
Address
Catholic University of Daegu (Daegu Catholic University Medical Center)
Daegu 1835329, , 42472
Status
Recruiting
Address
Seoul National University Hospital
Junggu 8606540, , 03080
Status
Recruiting
Address
Hanyang University Hospital, Seongdong-gu
Seoul 1835848, , 04763
Status
Active, not recruiting
Address
Ewha University Mokdong Hospital, Yangcheon-gu
Seoul 1835848, , 07985
Status
Recruiting
Address
KonKuk University Medical Center, Gwangjin-gu
Seoul 1835848, , 5030
Status
Recruiting
Address
Seoul Saint Mary's Hospital of the Catholic University of Korea, Seocho-gu
Seoul 1835848, , 6591
Status
Recruiting
Address
Kaohsiung Medical University Hospital
Kaohsiung City 1673820, , 807
Status
Recruiting
Address
Far Eastern Memorial Hospital
New Taipei City 12908892, , 220
Status
Recruiting
Address
China Medical University Hospital
Taichung 1668399, , 404
Status
Recruiting
Address
Chi Mei Medical Center
Tainan City 1668355, , 71004
Status
Recruiting
Address
National Taiwan University Hospital
Taipei 1668341, , 10002
Status
Recruiting
Address
Taipei Medical University Hospital
Taipei 1668341, , 110
Status
Recruiting
Address
Taipei Veterans General Hospital
Taipei 1668341, , 11217
Status
Recruiting
Address
Cheng Hsin General Hospital
Taipei 1668341, , 112
Status
Recruiting
Address
TRI-Service General Hospital
Taipei 1668341, , 114
Status
Recruiting
Address
Linkou Chang Gung Memorial Hospital
Taoyuan 6696918, , 33305
Status
Recruiting
Address
Vajira Hospital
Bangkok 1609350, , 10300
Status
Recruiting
Address
Srinagarind Hospital, Khon Kaen University
Khon Kaen 1609776, , 40002
Status
Recruiting
Address
Songklanagarind Hospital
Songkhla 1606147, , 90110
Status
Recruiting
Address
Communal Non-Commercial Enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"
Cherkasy 710791, , 18009
Status
Recruiting
Address
Communal Non-Commercial Enterprise "Khmelnytsky Regional Hospital" of Khmelnytsky Regional Council
Khmelnytskyi 706369, , 29000
Status
Recruiting
Address
Clinic of Modern Rheumatology
Kyiv 703448, , 02081
Status
Recruiting
Address
Kyiv City Clinical Hospital #3
Kyiv 703448, , 02125
Status
Not yet recruiting
Address
Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of Joint-Stock Company "Ukrainian Railway"
Kyiv 703448, , 03049
Status
Recruiting
Address
State Ins Nat Scie Cen M.D.Strazhesko Ins of Cardio Clin
Kyiv 703448, , 03151
Status
Recruiting
Address
Communal Non-Commercial Enterprise of Kyiv Regional Council Kyiv Clinical Regional Hospital, Consultation and Diagnostic Center
Kyiv 703448, , 04106
Status
Recruiting
Address
Volyn Regional Clinical Hospital
Lutsk 702569, , 43000
Status
Recruiting
Address
Com Non-Com Entr of Lviv Reg Coun "Lviv Reg Clin Hos, Rheu Dprt, Danylo Halytsky Lviv Nat Med Uni
Lviv 702550, , 79010
Status
Recruiting
Address
Medical Center of Limited Liability Company "Kalyna. Center of Modern Medicine
Lviv 702550, , 79034
Status
Recruiting
Address
Medical Centre "Academical Medical Group" LLC
Lviv 702550, , 79044
Status
Recruiting
Address
Uzhhorod City Multidisciplinary Clinical Hospital
Uzhhorod 690548, , 88000
Status
Recruiting
Address
Private Small-Scale Enterprise Medical Centre "Pulse", Therapeutical Department
Vinnytsia 689558, , 21001
Status
Recruiting
Address
Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital #1"
Vinnytsia 689558, , 21029
Status
Recruiting
Address
Communal Enterprise "Hospital #1" of Zhytomyr City Council, Consultation and Treatment Department "Scientific Research Center"
Zhytomyr 686967, , 10002