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Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
Sponsor: Viatris Innovation GmbH
Summary
The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus. The main questions it aims to answer are: * Whether cenerimod causes any adverse effects ('side effects') when given on top of drugs already being given for systemic lupus erythematosus. * How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for at least 1 year and up to 3 years. Participants taking part in this study will have already taken part in another study, where they received either cenerimod or placebo (look-alike substance containing no active drug) for 1 year. In this clinical study approximately 680 participants will receive cenerimod (on top of drugs already being given for systemic lupus erythematosus) for at least 1 year and up to 3 years.
Official title: A Phase 3, Multicenter, Open-label, Single-arm, Extension Study to Evaluate the Long-term Safety and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
680
Start Date
2024-07-30
Completion Date
2028-05
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
Cenerimod
Film-coated tablets at a dose of 4 mg.
Locations (92)
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Omega Research MetroWest, LLC
DeBary, Florida, United States
SouthCoast Research Center, Inc.
Miami, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
D&H National Research Centers INC
Miami, Florida, United States
San Marcus Res Clin Inc.
Miami Lakes, Florida, United States
Accurate Clinical Research Inc. - Lake Charles
Lake Charles, Louisiana, United States
RB Wellness Clinic
Las Vegas, Nevada, United States
Accurate Clinical Research Inc - (Najam)
Baytown, Texas, United States
Novel Research LLC
Bellaire, Texas, United States
Accurate Clinical Research Inc.
Houston, Texas, United States
Aprillus Asistencia e Investigacion
Buenos Aires, Argentina
Centro Médico Arsema
Buenos Aires, Argentina
Fundación Respirar
Buenos Aires, Argentina
IR Medical Center S.A.
Mendoza, Argentina
Instituto Medico CER
Quilmes, Argentina
Instituto CAICI SRL
Rosario, Argentina
Centro de investigaciones medicas Tucuman
San Miguel de Tucumán, Argentina
ICT (Investigaciones Clínicas Tucumán)
San Miguel de Tucumán, Argentina
LMK Servicos Medico S/S
Porto Alegre, Brazil
Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.
Plovdiv, Bulgaria
DCC Equita EOOD
Varna, Bulgaria
Enroll SpA
Providencia, Chile
Biomedica Research Group
Providencia, Chile
Sociedad Médica del Aparato Locomotor S. A.
Providencia, Chile
Centro de Especialidades Medicas Vanguardia
Temuco, Chile
Clinical Research Chile SpA
Valdivia, Chile
Hospital San José de Victoria
Victoria, Chile
Clínica de la costa S.A.S.
Barranquilla, Colombia
Centro de Estudios de Reumatología y Dermatología
Cali, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
Healthy Medical Center SAS
Zipaquirá, Colombia
iMedica s.r.o.
Brno, Czechia
Institute of Rheumatology Prague
Prague, Czechia
LTD "New Plasma Clinic"
Batumi, Georgia
Institute of Clinical Cardiology, Ltd
Tbilisi, Georgia
LTD "Tbilisi Central Hospital"
Tbilisi, Georgia
National Institute of Endocrinology Ltd.
Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic Ltd.
Tbilisi, 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
LTD "Tbilisi Heart Center"
Tbilisi, Georgia
Universitatsklinikum Leipzig
Leipzig, Germany
Klinik für Rheumatologie und Klinische Immunologie
Minden, Germany
General Hospital of Athens "Hippokration"
Athens, Greece
Euromedica - Kyanos Stavros
Thessaloniki, Greece
General Hospital of Thessaloniki "Hippokration"
Thessaloniki, Greece
424 General Military Hospital
Thessaloniki, Greece
Morales Vargas Centro de Investigación S.C.
León, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí City, Mexico
Centro de Investigación del Hospital Militar Central
Jesus Maria, Peru
Unidad de Investigación de la Clinica International
San Borja, Peru
Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion
Santiago de Surco, Peru
Chong-Hua Hospital
Cebu City, Philippines
Lipa Medix Medical Center
Lipa City, Philippines
Makati Medical Center
Makati, Philippines
Ospital ng Makati
Makati, Philippines
St Lukes Medical Center
Quezon City, Philippines
Far Eastern University - Nicanor Reyes Medical Foundation
Quezon City, Philippines
St Luke's Medical Center Quezon City / University of Santo Tomas Hospital
Sampaloc, Philippines
Jose R. Reyes Memorial Medical Center
Santa Cruz, Philippines
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, Poland
Centrum Medyczne Pratia Częstochowa
Częstochowa, Poland
Centrum Medyczne Angelius Provita
Katowice, Poland
Vita Longa Sp. z o.o.
Katowice, Poland
Medyczne Centrum Hetmanska
Poznan, Poland
Twoja Przychodnia Poznańskie Centrum Medyczne
Poznan, Poland
Malwa-Med Iwona Chlebicka
Wroclaw, Poland
Hospital Prof. Doutor Fernando Fonseca
Amadora, Portugal
Centro Hospitalar Universitário do Algarve - Hospital de Faro
Faro, Portugal
ULS Guarda
Guarda, Portugal
Hospital Senhora Oliveira-Guimaraes
Guimarães, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, Portugal
Centro Reumatologico de Caguas
Caguas, Puerto Rico
GCM Medical Group, PSC
San Juan, Puerto Rico
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L
Brasov, Romania
Institute of Rheumatology, Belgrade
Belgrade, Serbia
University Clinical Center of Serbia
Belgrade, Serbia
Special Hospital for Rheumatic Diseases, Novi Sad
Novi Sad, Serbia
Panorama Medical Centre
Panorama, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, South Africa
Seoul National University Hospital
Seoul, South Korea
Parc Taulí Sabadell University Hospital
Sabadell, Spain
Clinica Gaias Santiago
Santiago de Compostela, Spain
Hospital QuironSalud Sagrado Corazon
Seville, Spain
Hospital Universitario Río Hortega de Valladolid
Valladolid, Spain
Taipei Veterans General Hospital
Taipei, Taiwan
TRI-Service General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan