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

Recruitment Status: ENROLLING BY INVITATION
(See Contacts and Locations)Verified June 2026 by Viatris Innovation GmbH
Sponsor: Viatris Innovation GmbH
Information Provided by (Responsible Party): Viatris Innovation GmbH

Clinicaltrials.gov Identifier: NCT06475742
Other Study ID Numbers:: ID-064A303

First Submitted: June 19, 2024
First Posted: June 25, 2024
Last Update Posted: July 27, 2026
Last Verified: June 2026

ClinicalTrials.gov processed this data on July 2026. Link to the current ClinicalTrials.gov record .

Study Details

Study Description

Participants who completed the 12-month double-blind treatment period (cenerimod 4 mg or placebo) in either of the parent studies, ID-064A301 or ID-064A302, are eligible to participate in this extension study.

All participants in this study will receive cenerimod 4 mg for up to a maximum of 60 months (5 years). All participants may additionally receive standard of care treatment for systemic lupus erythematosus, i.e., at least 1 of the following: oral corticosteroids, antimalarial drugs, or immunosuppressant drugs.

The safety follow-up period starts on the day after the last dose of study treatment and ends after 6 months with the final study visit. Thus, the maximum duration of participation is 5.5 years.

Data collected in this extension study will allow an assessment of whether the safety and tolerability profile of cenerimod established in the controlled parent studies remains the same after a longer period of treatment.

Condition or Disease	Intervention/Treatment
Lupus Erythematosus, Systemic	Drug: Cenerimod

Study Design

Study Type	Interventional
Actual Enrollment	680 participants
Design Allocation	N/A
Interventional Model	Single Group Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
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
Study Start Date	July 29, 2024
Actual Primary Completion Date	1yr 7mos from now
Actual Study Completion Date	1yr 7mos from now

Groups and Cohorts

Group/Cohort	Intervention/Treatment
Cenerimod 4 mg Participants will receive oral cenerimod once daily in addition to background systemic lupus erythematosus therapy, for up to 5 years.	Drug: Cenerimod Film-coated tablets at a dose of 4 mg.

Outcome Measures

Primary Outcome Measures

Treatment-emergent adverse events
Occurrence of treatment-emergent adverse events up to the final study visit (maximum 5 years of study treatment plus 6-month safety follow-up period).
Serious adverse events
Occurrence of serious adverse events up to the final study visit (maximum 5 years of study treatment plus 6-month safety follow-up period).
Adverse events of special interest
Occurrence of adverse events of special interest up to the final study visit (maximum 5 years of study treatment plus 6-month safety follow-up period). Adverse events of special interest include the anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities, i.e., adverse events related to: * Effects on heart rate and rhythm * Hypotension * Hypertension * Cardiovascular * Hepatobiliary disorders / liver enzyme abnormalities * Pulmonary * Eye disorders * Infections * Skin malignancies * Non-skin malignancies

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	1. Signed and dated informed consent form prior to any study-mandated procedure. 2. Participants with a diagnosis of systemic lupus erythematosus who: Completed the 12-month double-blind treatment period of either of the parent studies (ID-064A301, ID-064A302). Did not meet any study treatment stopping criteria during the parent study. Completed the last scheduled visit of the parent study. Participants who did not complete the last scheduled visit for reasons beyond their control may be eligible for this study upon approval by the sponsor. 3. Women of child-bearing potential: Negative pregnancy test at Visit 1. Agreement to undertake monthly urine pregnancy tests from Visit 2 up to 6 months after study treatment discontinuation. Agreement to use a highly effective method of contraception from Visit 1 up to 6 months after study treatment discontinuation.
Exclusion Criteria	1. Poor compliance with study-mandated procedures during the parent study (ID-064A301 or ID-064A302), e.g., took less than 80% of the planned doses of double-blind study treatment; or did not attend a majority of the site visits, unless there was a medically justified reason as judged by the investigator. 2. Systemic lupus erythematosus driven renal disease, central nervous system lupus, or active severe or unstable neuropsychiatric systemic lupus erythematosus where, in the judgment of the investigator, protocol-specific systemic lupus erythematosus background therapy is insufficient, and the use of a more aggressive therapeutic approach or other treatments not permitted in the protocol is indicated. 3. Women of child-bearing potential planning to become pregnant up to the final study visit. 4. Judged not eligible to participate by the investigator, for any other reason. 5. Confirmed active or latent tuberculosis (applicable only if requested by local regulations).

Contacts and Locations

Sponsors and Collaborators	Viatris Innovation GmbH
Locations	University of Colorado Denver \| Aurora Colorado, United States, 80045Clinical Research of West Florida, Inc. \| Clearwater Florida, United States, 33765Omega Research MetroWest, LLC \| DeBary Florida, United States, 32713SouthCoast Research Center, Inc. \| Miami Florida, United States, 33136Allied Biomedical Research Institute \| Miami Florida, United States, 33155D&H National Research Centers INC \| Miami Florida, United States, 33155Professional research Center INC \| Miami Florida, United States, 33172San Marcus Res Clin Inc. \| Miami Lakes Florida, United States, 33014Accurate Clinical Research Inc. - Lake Charles \| Lake Charles Louisiana, United States, 70605RB Wellness Clinic \| Las Vegas Nevada, United States, 89102Accurate Clinical Research Inc - (Najam) \| Baytown Texas, United States, 77521Novel Research LLC \| Bellaire Texas, United States, 77401Accurate Clinical Research Inc. \| Houston Texas, United States, 77089Sun Research \| San Antonio Texas, United States, 78215Aprillus Asistencia e Investigacion \| Buenos Aires , Argentina, 1406Centro Médico Arsema \| Buenos Aires , Argentina, 1416Fundación Respirar \| Buenos Aires , Argentina, 1426IR Medical Center S.A. \| Mendoza , Argentina, 5500Instituto Medico CER \| Quilmes , Argentina, B1878DVBInstituto CAICI SRL \| Rosario , Argentina, S2000PBJCentro de investigaciones medicas Tucuman \| San Miguel de Tucumán , Argentina, T4000AXLICT (Investigaciones Clínicas Tucumán) \| San Miguel de Tucumán , Argentina, T4000ICLLMK Servicos Medico S/S \| Porto Alegre , Brazil, 90480000SER - Serviços Especializados em Reumatologia da Bahia \| Salvador , Brazil, 40150-150Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd. \| Plovdiv , Bulgaria, 4004DCC Equita EOOD \| Varna , Bulgaria, 9000Enroll SpA \| Providencia , Chile, 7500588Biomedica Research Group \| Providencia , Chile, 7500710Sociedad Médica del Aparato Locomotor S. A. \| Providencia , Chile, 7510186Centro de Especialidades Medicas Vanguardia \| Temuco , Chile, 4810345Clinical Research Chile SpA \| Valdivia , Chile, 5110683Hospital San José de Victoria \| Victoria , Chile, 4720000Clínica de la costa S.A.S. \| Barranquilla , Colombia, 080020IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán) \| Bogotá , Colombia, 110221Servimed S.A.S \| Bucaramanga , Colombia, 680003Centro de Estudios de Reumatología y Dermatología \| Cali , Colombia, 760042Preventive Care SAS \| Chía , Colombia, 250001Hospital Pablo Tobon Uribe \| Medellín , Colombia, 050034Healthy Medical Center SAS \| Zipaquirá , Colombia, 250252iMedica s.r.o. \| Brno , Czechia, 60200Institute of Rheumatology Prague \| Prague , Czechia, 128 00Centre Hospitalier Universitaire De La Reunion \| Saint-Denis , France, 97400LTD "New Plasma Clinic" \| Batumi , Georgia, 6010Institute of Clinical Cardiology, Ltd \| Tbilisi , Georgia, 0159LTD "Tbilisi Central Hospital" \| Tbilisi , Georgia, 0159National Institute of Endocrinology Ltd. \| Tbilisi , Georgia, 0159Tbilisi Heart and Vascular Clinic Ltd. \| Tbilisi , Georgia, 0159Aversi Clinic LTD \| Tbilisi , Georgia, 0160Medi Club Georgia Ltd. \| Tbilisi , Georgia, 0160Ltd. Mtskheta Street Clinic \| Tbilisi , Georgia, 0179The First Medical Center Ltd. \| Tbilisi , Georgia, 0180LLC "Innova" \| Tbilisi , Georgia, 0186LTD "Tbilisi Heart Center" \| Tbilisi , Georgia, 0186Universitatsklinikum Leipzig \| Leipzig , Germany, 4103Klinik für Rheumatologie und Klinische Immunologie \| Minden , Germany, 32429Naval Hospital of Athens \| Athens , Greece, 115 21General Hospital of Athens "Hippokration" \| Athens , Greece, 115 27University General Hospital Attikon General Hospital Of West Attica H Agia Varvara \| Chaïdári , Greece, 12462Euromedica - Kyanos Stavros \| Thessaloniki , Greece, 546 36General Hospital of Thessaloniki "Hippokration" \| Thessaloniki , Greece, 546 42424 General Military Hospital \| Thessaloniki , Greece, 564 29Sarawak General Hospital \| Kuching , Malaysia, 93586Morales Vargas Centro de Investigación S.C. \| León , Mexico, 37000Unidad de Atención Médica e Investigación en Salud \| Mérida , Mexico, 97070Centro de Atención e Investigación Cardiovascular del Potosí, S.C. \| San Luis Potosí City , Mexico, 78200Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. \| Zapopan , Mexico, 45070Centro de Investigación del Hospital Militar Central \| Jesus Maria , Peru, 15076Hospital Nacional Cayetano Heredia \| Lima , Peru, 15102Unidad de Investigación de la Clinica International \| San Borja , Peru, 15036Instituto Peruano del Hueso y la Articulación S.A.C. (IPHAR) \| San Isidro , Peru, 15046Unidad de Investigación en Reumatología e Inmunología CSJB \| San Juan de Lurigancho , Peru, 15431Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion \| Santiago de Surco , Peru, 15023Chong-Hua Hospital \| Cebu City , Philippines, 6000Davao Doctors Hospital \| Davao City , Philippines, 8000Iloilo Doctors Hospital \| Iloilo City , Philippines, 5000Lipa Medix Medical Center \| Lipa City , Philippines, 4217Makati Medical Center \| Makati , Philippines, 1229Ospital ng Makati \| Makati , Philippines, 1642St Lukes Medical Center \| Quezon City , Philippines, 1102Far Eastern University - Nicanor Reyes Medical Foundation \| Quezon City , Philippines, 1118St Luke's Medical Center Quezon City / University of Santo Tomas Hospital \| Sampaloc , Philippines, 1015Jose R. Reyes Memorial Medical Center \| Santa Cruz , Philippines, 1003/1014Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy \| Bydgoszcz , Poland, 85-168Centrum Medyczne Pratia Częstochowa \| Częstochowa , Poland, 42-217Centrum Medyczne Angelius Provita \| Katowice , Poland, 40-611Vita Longa Sp. z o.o. \| Katowice , Poland, 40-748Medyczne Centrum Hetmanska \| Poznan , Poland, 60-218Twoja Przychodnia Poznańskie Centrum Medyczne \| Poznan , Poland, 60-324Malwa-Med Iwona Chlebicka \| Wroclaw , Poland, 50-304Hospital Prof. Doutor Fernando Fonseca \| Amadora , Portugal, 2730-276Centro Hospitalar Universitário do Algarve - Hospital de Faro \| Faro , Portugal, 8000-386ULS Guarda \| Guarda , Portugal, 6300-749Hospital Senhora Oliveira-Guimaraes \| Guimarães , Portugal, 4835-044Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. \| Vila Nova de Gaia , Portugal, 4434-502Centro Reumatologico de Caguas \| Caguas , Puerto Rico, 00725GCM Medical Group, PSC \| San Juan , Puerto Rico, 00917Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L \| Brasov , Romania, 500283Institute for Rheumatology, Belgrade \| Belgrade , Serbia, 11000Institute of Rheumatology, Belgrade \| Belgrade , Serbia, 11000University Clinical Center of Serbia \| Belgrade , Serbia, 11000Military Medical Academy \| Belgrade , Serbia, 11040Special Hospital for Rheumatic Diseases, Novi Sad \| Novi Sad , Serbia, 21000Arthritis Clinical Research Trials \| Cape Town , South Africa, 7405Panorama Medical Centre \| Panorama , South Africa, 7500Charlotte Maxeke Johannesburg Academic Hospital \| Parktown , South Africa, 2193University of Pretoria \| Pretoria , South Africa, 0002Seoul National University Hospital \| Seoul , South Korea, 03080Parc Taulí Sabadell University Hospital \| Sabadell , Spain, 08208Clinica Gaias Santiago \| Santiago de Compostela , Spain, 15702Hospital QuironSalud Sagrado Corazon \| Seville , Spain, 41013Hospital Universitario Río Hortega de Valladolid \| Valladolid , Spain, 47012National Taiwan University Hospital \| Taipei , Taiwan, 100225Taipei Veterans General Hospital \| Taipei , Taiwan, 11217TRI-Service General Hospital \| Taipei , Taiwan, 114202Linkou Chang Gung Memorial Hospital \| Taoyuan City , Taiwan, 333423Rajavithi Hospital \| Bangkok , Thailand, 10400Ramathibodi Hospital \| Bangkok , Thailand, 10400Songklanagarind Hospital \| Songkhla , Thailand, 90110Communal Non-Commercial Enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council", Cardio-Rheumatology Department \| Cherkasy , Ukraine, 18009Medical Center LLC "Institute of Rheumatology", clinical trials department No.1 \| Kyiv , Ukraine, 02081Limited Liability Company "Medical Centre 'Consilium Medical'", Clinical and Consultation Department \| Kyiv , Ukraine, 04050Ternopil Regional Clinical Hospital, Department of Internal Medicine No.2 \| Ternopil , Ukraine, 46002
Investigators	Study Director: Clinical Trials, Viatris Innovation GmbH

More Information

Additional Relevant MeSH Terms

Lupus Erythematosus, SystemicSkin and Connective Tissue DiseasesConnective Tissue DiseasesImmune System DiseasesAutoimmune Diseases