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ENROLLING BY INVITATION
NCT06475742
PHASE3

Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus

Sponsor: Viatris Innovation GmbH

View on ClinicalTrials.gov

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

Interventions

DRUG

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