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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: Cenerimod

Detailed 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 at least 12 months (1 year) and up to a maximum of 36 months (3 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.

When all participants have reached at least 12 months of study treatment or have prematurely discontinued study treatment before the end of Month 12, the end-of-treatment will be scheduled for all participants who are still on study treatment.

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 3.5 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.

• Study Type: Interventional
• Enrollment (Estimated): 680
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426
    • Fundación Respirar
  • Buenos Aires, Argentina, 1406
    • APRILLUS Asistencia E Investigacion
  • Buenos Aires, Argentina, 1416
    • Centro Médico Arsema
  • Mendoza, Argentina, 5500
    • IR Medical Center S.A.
  • Quilmes, Argentina, B1878DVB
    • Instituto Médico Cer
  • Rosario, Argentina, S2000PBJ
    • Instituto CAICI SRL
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro de Investigaciones Médicas Tucumán
  • San Miguel de Tucumán, Argentina, T4000ICL
    • ICT (Investigaciones Clínicas Tucumán)
• Brazil
  • Porto Alegre, Brazil, 90480000
    • LMK Servicos Medico S/S
  • Salvador, Brazil, 40150-150
    • SER - Servicos Especializados em Reumatologia da Bahia
• Bulgaria
  • Plovdiv, Bulgaria, 4004
    • Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.
  • Varna, Bulgaria, 9000
    • DCC Equita EOOD
• Chile
  • Providencia, Chile, 7500588
    • Enroll SpA
  • Providencia, Chile, 7500710
    • Biomedica Research Group
  • Providencia, Chile, 7510186
    • Sociedad Médica del Aparato Locomotor S. A.
  • Temuco, Chile, 4810345
    • Centro de especialidades médicas Vanguardia
  • Valdivia, Chile, 5110683
    • Clinical Research Chile SpA
  • Victoria, Chile, 4720000
    • Hospital San Jose de Victoria
• Colombia
  • Barranquilla, Colombia, 080020
    • Clinica de la Costa S.A.S.
  • Bucaramanga, Colombia, 680003
    • Servimed S.A.S
  • Cali, Colombia, 760042
    • Centro de Estudios de Reumatología y Dermatología
  • Chía, Colombia, 250001
    • Preventive Care SAS
  • Medellín, Colombia, 050034
    • Hospital Pablo Tobón Uribe
  • Zipaquirá, Colombia, 250252
    • Healthy Medical Center SAS
• Czechia
  • Brno, Czechia, 60200
    • iMedica s.r.o.
  • Prague, Czechia, 128 00
    • Institute of Rheumatology Prague
• Georgia
  • Batumi, Georgia, 6010
    • LTD "New Plasma Clinic"
  • Tbilisi, Georgia, 0160
    • Aversi Clinic Ltd
  • Tbilisi, Georgia, 0160
    • Medi Club Georgia Ltd.
  • Tbilisi, Georgia, 0179
    • Ltd. Mtskheta Street Clinic
  • Tbilisi, Georgia, 0180
    • The First Medical Center Ltd.
  • Tbilisi, Georgia, 0186
    • LLC "Innova"
  • Tbilisi, Georgia, 0186
    • LTD "Tbilisi Heart Center"
  • Tbilisi, Georgia, 0159
    • Institute of Clinical Cardiology, Ltd
  • Tbilisi, Georgia, 0159
    • LTD "Tbilisi Central Hospital"
  • Tbilisi, Georgia, 0159
    • National Institute of Endocrinology Ltd.
  • Tbilisi, Georgia, 0159
    • Tbilisi Heart and Vascular Clinic Ltd.
• Germany
  • Leipzig, Germany, 4103
    • Universitatsklinikum Leipzig
  • Minden, Germany, 32429
    • Klinik für Rheumatologie und Klinische Immunologie
• Greece
  • Athens, Greece, 115 27
    • General Hospital of Athens "Hippokration"
  • Athens, Greece, 115 21
    • Naval Hospital of Athens
  • Thessaloniki, Greece, 546 36
    • Euromedica - Kyanos Stavros
  • Thessaloniki, Greece, 546 42
    • General Hospital of Thessaloniki "Hippokration"
  • Thessaloniki, Greece, 564 29
    • 424 General Military Hospital
• Mexico
  • León, Mexico, 37000
    • Morales Vargas Centro de Investigación S.C.
  • San Luis Potosí City, Mexico, 78200
    • Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
• Peru
  • Jesus Maria, Peru, 15076
    • Centro de Investigación del Hospital Militar Central
  • Lima, Peru, 15102
    • Hospital Nacional Cayetano Heredia
  • San Borja, Peru, 15036
    • Unidad de Investigación de la Clinica International
  • San Juan de Lurigancho, Peru, 15431
    • Unidad de Investigación en Reumatología e Inmunología CSJB
  • Santiago de Surco, Peru, 15023
    • Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion
• Philippines
  • Cebu City, Philippines, 6000
    • Chong-Hua Hospital
  • Davao City, Philippines, 8000
    • Davao Doctors Hospital
  • Iloilo City, Philippines, 5000
    • Iloilo Doctors Hospital
  • Lipa City, Philippines, 4217
    • Lipa Medix Medical Center
  • Makati, Philippines, 1229
    • Makati Medical Center
  • Makati, Philippines, 1642
    • Ospital ng Makati
  • Quezon City, Philippines, 1102
    • St Lukes Medical Center
  • Quezon City, Philippines, 1118
    • Far Eastern University - Nicanor Reyes Medical Foundation
  • Sampaloc, Philippines, 1015
    • St Luke's Medical Center Quezon City / University of Santo Tomas Hospital
  • Santa Cruz, Philippines, 1003/1014
    • Jose R. Reyes Memorial Medical Center
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
  • Częstochowa, Poland, 42-217
    • Centrum Medyczne Pratia Częstochowa
  • Katowice, Poland, 40-748
    • Vita Longa Sp. z o.o.
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Poznan, Poland, 60-218
    • Medyczne Centrum Hetmańska
  • Poznan, Poland, 60-324
    • Twoja Przychodnia Poznańskie Centrum Medyczne
  • Wroclaw, Poland, 50-304
    • Malwa-Med Iwona Chlebicka
• Portugal
  • Amadora, Portugal, 2730-276
    • Hospital Prof. Doutor Fernando Fonseca
  • Faro, Portugal, 8000-386
    • Centro Hospitalar Universitário do Algarve - Hospital de Faro
  • Guarda, Portugal, 6300-749
    • ULS Guarda
  • Guimarães, Portugal, 4835-044
    • Hospital Senhora Oliveira-Guimaraes
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Centro Reumatologico de Caguas
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group, PSC
• Romania
  • Brasov, Romania, 500283
    • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology, Belgrade
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia
  • Belgrade, Serbia, 11040
    • Military Medical Academy
  • Novi Sad, Serbia, 21000
    • Special Hospital for Rheumatic Diseases, Novi Sad
• South Africa
  • Cape Town, South Africa, 7405
    • Arthritis Clinical Research Trials
  • Panorama, South Africa, 7500
    • Panorama Medical Centre
  • Parktown, South Africa, 2193
    • Charlotte Maxeke Johannesburg Academic Hospital
  • Pretoria, South Africa, 0002
    • University Of Pretoria
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
• Spain
  • Sabadell, Spain, 08208
    • Parc Taulí Sabadell University Hospital
  • Santiago de Compostela, Spain, 15702
    • Clínica Gaias Santiago
  • Seville, Spain, 41013
    • Hospital Quirónsalud Sagrado Corazón
  • Valladolid, Spain, 47012
    • Hospital Universitario Río Hortega de Valladolid
• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 114202
    • Tri-Service General Hospital
  • Taoyuan City, Taiwan, 333423
    • Linkou Chang Gung Memorial Hospital
• Thailand
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital
• United States
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • DeBary, Florida, United States, 32713
      • Omega Research MetroWest, LLC
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research Institute
    • Miami, Florida, United States, 33136
      • SouthCoast Research Center, Inc.
    • Miami, Florida, United States, 33155
      • D&H National Research Centers INC
    • Miami, Florida, United States, 33172
      • Professional Research Center Inc
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Res Clin Inc.
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Accurate Clinical Research Inc. - Lake Charles
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • RB Wellness Clinic
  • Texas
    • Baytown, Texas, United States, 77521
      • Accurate Clinical Research Inc - (Najam)
    • Bellaire, Texas, United States, 77401
      • Novel Research LLC
    • Houston, Texas, United States, 77089
      • Accurate Clinical Research Inc.
    • San Antonio, Texas, United States, 78215
      • Sun Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cenerimod 4 mg; Participants 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.	Drug: Cenerimod; Film-coated tablets at a dose of 4 mg.; Other Names: ACT-334441

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Viatris Innovation GmbH
• Investigators: Study Director: Clinical Trials, Viatris Innovation GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Immune System Diseases; Connective Tissue Diseases; Autoimmune Diseases; Musculoskeletal and connective tissue disorders; Skin and Connective Tissue Diseases
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic; Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; cenerimod
• Other Study ID Numbers: ID-064A303; 2024-514354-67-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No