Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
OPUS OLE
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
2 other identifiers
interventional
680
23 countries
106
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2024
Typical duration for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2024
CompletedFirst Posted
Study publicly available on registry
June 26, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
May 6, 2026
August 1, 2025
3.8 years
June 20, 2024
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Treatment-emergent adverse events
Occurrence of treatment-emergent adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).
Day 1 (post dose) to a maximum of 3.5 years
Serious adverse events
Occurrence of serious adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).
Day 1 (post dose) to a maximum of 3.5 years
Adverse events of special interest
Occurrence of adverse events of special interest up to the final study visit (maximum 3 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
Day 1 (post dose) to a maximum of 3.5 years
Study Arms (1)
Cenerimod 4 mg
EXPERIMENTALParticipants will receive oral cenerimod once daily in addition to background systemic lupus erythematosus therapy, for at least 1 year and up to a maximum of 3 years.
Interventions
Eligibility Criteria
You may qualify if:
- Signed and dated informed consent form prior to any study-mandated procedure.
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- Women of child-bearing potential planning to become pregnant up to the final study visit.
- Judged not eligible to participate by the investigator, for any other reason.
- Confirmed active or latent tuberculosis (applicable only if requested by local regulations).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Omega Research MetroWest, LLC
DeBary, Florida, 32713, United States
SouthCoast Research Center, Inc.
Miami, Florida, 33136, United States
Allied Biomedical Research Institute
Miami, Florida, 33155, United States
D&H National Research Centers INC
Miami, Florida, 33155, United States
Professional research Center INC
Miami, Florida, 33172, United States
San Marcus Res Clin Inc.
Miami Lakes, Florida, 33014, United States
Accurate Clinical Research Inc. - Lake Charles
Lake Charles, Louisiana, 70605, United States
RB Wellness Clinic
Las Vegas, Nevada, 89102, United States
Accurate Clinical Research Inc - (Najam)
Baytown, Texas, 77521, United States
Novel Research LLC
Bellaire, Texas, 77401, United States
Accurate Clinical Research Inc.
Houston, Texas, 77089, United States
Sun Research
San Antonio, Texas, 78215, United States
Aprillus Asistencia e Investigacion
Buenos Aires, 1406, Argentina
Centro Médico Arsema
Buenos Aires, 1416, Argentina
Fundación Respirar
Buenos Aires, 1426, Argentina
IR Medical Center S.A.
Mendoza, 5500, Argentina
Instituto Medico CER
Quilmes, B1878DVB, Argentina
Instituto CAICI SRL
Rosario, S2000PBJ, Argentina
Centro de investigaciones medicas Tucuman
San Miguel de Tucumán, T4000AXL, Argentina
ICT (Investigaciones Clínicas Tucumán)
San Miguel de Tucumán, T4000ICL, Argentina
LMK Servicos Medico S/S
Porto Alegre, 90480000, Brazil
SER - Serviços Especializados em Reumatologia da Bahia
Salvador, 40150-150, Brazil
Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.
Plovdiv, 4004, Bulgaria
DCC Equita EOOD
Varna, 9000, Bulgaria
Enroll SpA
Providencia, 7500588, Chile
Biomedica Research Group
Providencia, 7500710, Chile
Sociedad Médica del Aparato Locomotor S. A.
Providencia, 7510186, Chile
Centro de Especialidades Medicas Vanguardia
Temuco, 4810345, Chile
Clinical Research Chile SpA
Valdivia, 5110683, Chile
Hospital San José de Victoria
Victoria, 4720000, Chile
Clínica de la costa S.A.S.
Barranquilla, 080020, Colombia
Servimed S.A.S
Bucaramanga, 680003, Colombia
Centro de Estudios de Reumatología y Dermatología
Cali, 760042, Colombia
Preventive Care SAS
Chía, 250001, Colombia
Hospital Pablo Tobon Uribe
Medellín, 050034, Colombia
Healthy Medical Center SAS
Zipaquirá, 250252, Colombia
iMedica s.r.o.
Brno, 60200, Czechia
Institute of Rheumatology Prague
Prague, 128 00, Czechia
LTD "New Plasma Clinic"
Batumi, 6010, Georgia
Institute of Clinical Cardiology, Ltd
Tbilisi, 0159, Georgia
LTD "Tbilisi Central Hospital"
Tbilisi, 0159, Georgia
National Institute of Endocrinology Ltd.
Tbilisi, 0159, Georgia
Tbilisi Heart and Vascular Clinic Ltd.
Tbilisi, 0159, Georgia
Aversi Clinic LTD
Tbilisi, 0160, Georgia
Medi Club Georgia Ltd.
Tbilisi, 0160, Georgia
Ltd. Mtskheta Street Clinic
Tbilisi, 0179, Georgia
The First Medical Center Ltd.
Tbilisi, 0180, Georgia
LLC "Innova"
Tbilisi, 0186, Georgia
LTD "Tbilisi Heart Center"
Tbilisi, 0186, Georgia
Universitatsklinikum Leipzig
Leipzig, 4103, Germany
Klinik für Rheumatologie und Klinische Immunologie
Minden, 32429, Germany
Naval Hospital of Athens
Athens, 115 21, Greece
General Hospital of Athens "Hippokration"
Athens, 115 27, Greece
Euromedica - Kyanos Stavros
Thessaloniki, 546 36, Greece
General Hospital of Thessaloniki "Hippokration"
Thessaloniki, 546 42, Greece
424 General Military Hospital
Thessaloniki, 564 29, Greece
Morales Vargas Centro de Investigación S.C.
León, 37000, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí City, 78200, Mexico
Centro de Investigación del Hospital Militar Central
Jesus Maria, 15076, Peru
Hospital Nacional Cayetano Heredia
Lima, 15102, Peru
Unidad de Investigación de la Clinica International
San Borja, 15036, Peru
Unidad de Investigación en Reumatología e Inmunología CSJB
San Juan de Lurigancho, 15431, Peru
Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion
Santiago de Surco, 15023, Peru
Chong-Hua Hospital
Cebu City, 6000, Philippines
Davao Doctors Hospital
Davao City, 8000, Philippines
Iloilo Doctors Hospital
Iloilo City, 5000, Philippines
Lipa Medix Medical Center
Lipa City, 4217, Philippines
Makati Medical Center
Makati, 1229, Philippines
Ospital ng Makati
Makati, 1642, Philippines
St Lukes Medical Center
Quezon City, 1102, Philippines
Far Eastern University - Nicanor Reyes Medical Foundation
Quezon City, 1118, Philippines
St Luke's Medical Center Quezon City / University of Santo Tomas Hospital
Sampaloc, 1015, Philippines
Jose R. Reyes Memorial Medical Center
Santa Cruz, 1003/1014, Philippines
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Centrum Medyczne Pratia Częstochowa
Częstochowa, 42-217, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
Vita Longa Sp. z o.o.
Katowice, 40-748, Poland
Medyczne Centrum Hetmanska
Poznan, 60-218, Poland
Twoja Przychodnia Poznańskie Centrum Medyczne
Poznan, 60-324, Poland
Malwa-Med Iwona Chlebicka
Wroclaw, 50-304, Poland
Hospital Prof. Doutor Fernando Fonseca
Amadora, 2730-276, Portugal
Centro Hospitalar Universitário do Algarve - Hospital de Faro
Faro, 8000-386, Portugal
ULS Guarda
Guarda, 6300-749, Portugal
Hospital Senhora Oliveira-Guimaraes
Guimarães, 4835-044, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502, Portugal
Centro Reumatologico de Caguas
Caguas, 00725, Puerto Rico
GCM Medical Group, PSC
San Juan, 00917, Puerto Rico
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L
Brasov, 500283, Romania
Institute of Rheumatology, Belgrade
Belgrade, 11000, Serbia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11040, Serbia
Special Hospital for Rheumatic Diseases, Novi Sad
Novi Sad, 21000, Serbia
Arthritis Clinical Research Trials
Cape Town, 7405, South Africa
Panorama Medical Centre
Panorama, 7500, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, 2193, South Africa
University of Pretoria
Pretoria, 0002, South Africa
Seoul National University Hospital
Seoul, 03080, South Korea
Parc Taulí Sabadell University Hospital
Sabadell, 08208, Spain
Clinica Gaias Santiago
Santiago de Compostela, 15702, Spain
Hospital QuironSalud Sagrado Corazon
Seville, 41013, Spain
Hospital Universitario Río Hortega de Valladolid
Valladolid, 47012, Spain
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
TRI-Service General Hospital
Taipei, 114202, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan City, 333423, Taiwan
Songklanagarind Hospital
Songkhla, 90110, Thailand
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Trials
Viatris Innovation GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2024
First Posted
June 26, 2024
Study Start
July 30, 2024
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
May 6, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share