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Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Sponsor: Viatris Innovation GmbH
Summary
The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).
Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
427
Start Date
2018-12-21
Completion Date
2022-08-25
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Cenerimod 0.5 mg
Cenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg
Cenerimod 1 mg
Cenerimod will be supplied as a film-coated tablets at the dose of 1 mg
Cenerimod 2 mg
Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg
Cenerimod 4 mg
Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg
Placebo
Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod
cenerimod 2 mg (ex-4 mg)
Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg
Locations (148)
Pinnacle Research Group
Anniston, Alabama, United States
University of California San Diego
La Jolla, California, United States
Valerius Medical Group and Research Center
Los Alamitos, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Robert W Levin MD PA
Clearwater, Florida, United States
Center for Rheumatology Immunology and Arthritis
Fort Lauderdale, Florida, United States
Life Clinical Trials
Margate, Florida, United States
D&H National Research Centers INC
Miami, Florida, United States
San Marcus Research Clinic
Miami Lakes, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States
Advanced Research Institute Inc Allergy & Rheumatology
St. Petersburg, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
North Georgia Rheumatology Group - Duluth
Lawrenceville, Georgia, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Washington University School of Medicine
St Louis, Missouri, United States
Innovative Health Research
Las Vegas, Nevada, United States
New York Presbyterian Columbia University Medical Center
New York, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Joint Muscle Medical Care and Research Institute - Lilington Office
Charlotte, North Carolina, United States
DJL Clinical Research
Charlotte, North Carolina, United States
Paramount Medical Research and Consulting
Middleburg Heights, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Office of Ramesh C. Gupta, MD
Memphis, Tennessee, United States
Amarillo Center for Clinical Research
Amarillo, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Accurate Clinical Management
Stafford, Texas, United States
Multiprofile Hospital For Active Treatment Trimontium
Plovdiv, Plodiv, Bulgaria
University Multiprofile Hospital for Active Treatment Pulmed
Plovdiv, Bulgaria
Diagnostic and Consulting Center "Aleksandrovska" EOOD
Sofia, Bulgaria
Diagnostic Consulting Center Fokus-5
Sofia, Bulgaria
Enroll SpA
Santiago, Chile
Biomedica Research Group
Santiago, Chile
Meditek Ltda.
Santiago, Chile
Prosalud
Santiago, Chile
Clinical Research Chile SpA
Valdivia, Chile
CCR Pardubice
Pardubice, Vychodocesky KRAJ, Czechia
Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest
Brest, Brittany Region, France
Hôpital Haut-Lévêque
Pessac, France
LTD "New Plasma Clinic"
Batumi, Georgia
Aversi Clinic LTD
Tbilisi, Georgia
Medi Club Georgia Ltd.
Tbilisi, Georgia
Ltd. Mtskheta Street Clinic
Tbilisi, Georgia
The First Medical Center Ltd.
Tbilisi, Georgia
LLC "Innova"
Tbilisi, Georgia
LLC Raymann
Tbilisi, Georgia
LTD "Tbilisi Heart Center"
Tbilisi, Georgia
Medicore
Tbilisi, Georgia
Multiprofile Clinic Consilium Medulla
Tbilisi, Georgia
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany
General Hospital of Athens "Laiko"
Goudi, Greece
Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet
Budapest, Budapest, Hungary
Rambam Healthcare Campus
Haifa, Israel
Bnai Zion Medical Center
Haifa, Israel
Galilee Medical Center
Nahariya, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
A.O. Mauriziano Umberto I di Torino
Torino, Torino, Italy
LUPUS CLINIC c/o DIMI
Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, Italy
Tomakomai City Hospital
Tomakomai-shi, Japan
Consultorio Particular Dr. Miguel Cortés Hernández
Cuernavaca, Mexico
Centro Integral en Reumatología S.A. de C.V.
Guadalajara, Mexico
Icle S.C.
Guadalajara, Mexico
Consultorio Privado de Especialidad del Dr. José Javier Orozco Alcalá
Guadalajara, Mexico
Consultorio Médico del Dr. Federico Galván Villegas
Guadalajara, Mexico
Morales Vargas Centro de Investigación S.C.
León, Mexico
Karla Adriana Espinosa Bautista
Mexico City, Mexico
Centro de Investigación Clínica GRAMEL, S.C.
Mexico City, Mexico
Biológicos Especializados S.A. de C.V.
Mexico City, Mexico
Unidad de Atención Médica e Investigación en Salud
Mérida, Mexico
Kohler & Milstein Research S.A. de C.V.
Mérida, Mexico
Accelerium, S. de R.L. de C.V.
Monterrey, Mexico
UBAM Unidad Biomédica Avanzada Monterrey
Monterrey, Mexico
SMIQ, S. de R.L. de C.V.
Querétaro, Mexico
Hospital Universitario "Dr. Gonzalo Valdés Valdés"
Saltillo, Mexico
Unidad de Investigaciones Reumatológicas A.C.
San Luis Potosí City, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí City, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Mexico
Lipa Medix Medical Center
Lipa City, Batangas, Philippines
Angeles University Foundation Medical Center
Angeles City, Philippines
Davao Doctors Hospital
Davao City, Philippines
Iloilo Doctors Hospital
Iloilo City, Philippines
Makati Medical Center
Makati City, Philippines
University of the Philippines Manila - Philippine General Hospital
Manila, Philippines
Jose R. Reyes Memorial Medical Center
Manila, Philippines
University of Santo Tomas Hospital
Manila, Philippines
St. Luke's Medical Center
Quezon City, Philippines
Far Eastern University - Nicanor Reyes Medical Foundation
Quezon City, Philippines
Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, Poland
Intermedius Uslugi Medyczne
Kościan, Poland
Szpital Specjalistyczny im. J. Dietla w Krakowie
Krakow, Poland
Centrum Medyczne Plejady
Krakow, Poland
Twoja Przychodnia Poznańskie Centrum Medyczne
Poznan, Poland
Śląskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepełnosprawności im gen. Jerzego Zi
Ustroń, Poland
Centro Reumatologico de Caguas
Caguas, Puerto Rico
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
Brasov, Romania
SC Sana Monitoring SRL
Bucharest, Romania
Spitalul Clinic "Sf. Maria"
Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, Romania
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, Russia
City Clinical Hospital #15 named after O.M. Filatova
Moscow, Russia
Federal State Budget Scientific Research Institution "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
Moscow, Russia
Non-governmental private healthcare organization, Scientific Clinical Centre of JSC Russian Railways
Moscow, Russia
Medical Center "Zdorovaya Semiya", LLC
Novosibirsk, Russia
Orenburg State Medical University
Orenburg, Russia
Clinical Rheumatological Hospital Number 25
Saint Petersburg, Russia
Military Medical Academy S.M. Kirov
Saint Petersburg, Russia
Polyclinic of Private Security and Detectives
Saint Petersburg, Russia
Medical Research Institute, LLC
Saint Petersburg, Russia
Medical Center Maksimum Zdorovia
Saint Petersburg, Russia
Saratov Regional Clinical Hospital
Saratov, Russia
State Institution of Health Protection "Clinical Hospital #8"
Yaroslavl, Russia
JSC "Center of Family Medicine"
Yekaterinburg, Russia
Hospital Universitario Regional de Málaga
Málaga, MALAGA, Spain
Hospital Quirónsalud Infanta Luisa
Seville, SEVILLA, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Doctor Peset
Valencia, Spain
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Rajavithi Hospital
Bangkok, Thailand
Songklanagarind Hospital
Songkhla, Thailand
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, Turkey (Türkiye)
Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi
Konya, Turkey (Türkiye)
Kyiv City Clinical Hospital №3
Kyiv, Ukraine
Clinic of State Institution "National Scientific Centre "Acad. Strazhesko Institute of Cardiology"
Kyiv, Ukraine
Medical Centre "Consilium medical"
Kyiv, Ukraine
Municipal Institution Kyiv Regional Council "Kyiv Regional Clinical Hospital"
Kyiv, Ukraine
Municipal Nonprofit Institution of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, Ukraine
Municipal Nonprofit Institution of Lviv Regional Council
Lviv, Ukraine
Lviv Regional Clinical Hospital
Lviv, Ukraine
Poltava Regional Clinical Hospital named after M.V. Sklifossovsky
Poltava, Ukraine
Ternopil University Clinic - Rheumatology department
Ternopil, Ukraine
Zakarpattya Regional Clinical Hospital n.a. A.Novak - Rheumatology Department
Uzhhorod, Ukraine
Private Small Scale Medical Center "Pulse"
Vinnytsia, Ukraine
Medical Center "Health Clinic", LLC
Vinnytsia, Ukraine
Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital №1"
Vinnytsia, Ukraine
Vinnytsya Regional Clinical Hospital - Rheumatology Department
Vinnytsia, Ukraine
Scientific and Research Institute of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU,
Vinnytsia, Ukraine
Municipal Institution "Zaporizhzhya Regional Clinical Hospital"
Zaporizhzhya, Ukraine
Municipal institution "Regional Clinical Hospital n.a. O.F. Herbachevskoho"
Zhytomyr, Ukraine
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust
London, United Kingdom