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Lupus Erythematosus, SystemicPhase 3OPUS OLENCT06475742

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

A Phase 3 study testing Cenerimod in people with Lupus Erythematosus, Systemic, run by Viatris Innovation GmbH at 122 sites in 26 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Cenerimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
680 participants
Where
122 sitesin 26 countries
Study dates
30 Jul 2024to Sep 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

122 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

122 sites in 26 countries

United States14 sites

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Accurate Clinical Research Inc - (Najam)

    Baytown, Texas, 77521

  • Novel Research LLC

    Bellaire, Texas, 77401

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Omega Research MetroWest, LLC

    DeBary, Florida, 32713

  • Accurate Clinical Research Inc.

    Houston, Texas, 77089

  • Accurate Clinical Research Inc. - Lake Charles

    Lake Charles, Louisiana, 70605

  • RB Wellness Clinic

    Las Vegas, Nevada, 89102

  • SouthCoast Research Center, Inc.

    Miami, Florida, 33136

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • D&H National Research Centers INC

    Miami, Florida, 33155

  • Professional research Center INC

    Miami, Florida, 33172

  • San Marcus Res Clin Inc.

    Miami Lakes, Florida, 33014

  • Sun Research

    San Antonio, Texas, 78215

Other trials in United States

Georgia11 sites

  • LTD "New Plasma Clinic"

    Batumi, 6010

  • Institute of Clinical Cardiology, Ltd

    Tbilisi, 0159

  • LTD "Tbilisi Central Hospital"

    Tbilisi, 0159

  • National Institute of Endocrinology Ltd.

    Tbilisi, 0159

  • Tbilisi Heart and Vascular Clinic Ltd.

    Tbilisi, 0159

  • Aversi Clinic LTD

    Tbilisi, 0160

  • Medi Club Georgia Ltd.

    Tbilisi, 0160

  • Ltd. Mtskheta Street Clinic

    Tbilisi, 0179

  • The First Medical Center Ltd.

    Tbilisi, 0180

  • LLC "Innova"

    Tbilisi, 0186

  • LTD "Tbilisi Heart Center"

    Tbilisi, 0186

Other trials in Georgia

Philippines10 sites

  • Chong-Hua Hospital

    Cebu City, 6000

  • Davao Doctors Hospital

    Davao City, 8000

  • Iloilo Doctors Hospital

    Iloilo City, 5000

  • Lipa Medix Medical Center

    Lipa City, 4217

  • Makati Medical Center

    Makati, 1229

  • Ospital ng Makati

    Makati, 1642

  • St Lukes Medical Center

    Quezon City, 1102

  • Far Eastern University - Nicanor Reyes Medical Foundation

    Quezon City, 1118

  • St Luke's Medical Center Quezon City / University of Santo Tomas Hospital

    Sampaloc, 1015

  • Jose R. Reyes Memorial Medical Center

    Santa Cruz, 1003/1014

Other trials in Philippines

Argentina8 sites

  • Aprillus Asistencia e Investigacion

    Buenos Aires, 1406

  • Centro Médico Arsema

    Buenos Aires, 1416

  • Fundación Respirar

    Buenos Aires, 1426

  • IR Medical Center S.A.

    Mendoza, 5500

  • Instituto Medico CER

    Quilmes, B1878DVB

  • Instituto CAICI SRL

    Rosario, S2000PBJ

  • Centro de investigaciones medicas Tucuman

    San Miguel de Tucumán, T4000AXL

  • ICT (Investigaciones Clínicas Tucumán)

    San Miguel de Tucumán, T4000ICL

Other trials in Argentina

Colombia7 sites

  • Clínica de la costa S.A.S.

    Barranquilla, 080020

  • IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)

    Bogotá, 110221

  • Servimed S.A.S

    Bucaramanga, 680003

  • Centro de Estudios de Reumatología y Dermatología

    Cali, 760042

  • Preventive Care SAS

    Chía, 250001

  • Hospital Pablo Tobon Uribe

    Medellín, 050034

  • Healthy Medical Center SAS

    Zipaquirá, 250252

Other trials in Colombia

Poland7 sites

  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Centrum Medyczne Pratia Częstochowa

    Częstochowa, 42-217

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

  • Medyczne Centrum Hetmanska

    Poznan, 60-218

  • Twoja Przychodnia Poznańskie Centrum Medyczne

    Poznan, 60-324

  • Malwa-Med Iwona Chlebicka

    Wroclaw, 50-304

Other trials in Poland

Chile6 sites

  • Enroll SpA

    Providencia, 7500588

  • Biomedica Research Group

    Providencia, 7500710

  • Sociedad Médica del Aparato Locomotor S. A.

    Providencia, 7510186

  • Centro de Especialidades Medicas Vanguardia

    Temuco, 4810345

  • Clinical Research Chile SpA

    Valdivia, 5110683

  • Hospital San José de Victoria

    Victoria, 4720000

Other trials in Chile

Greece6 sites

  • Naval Hospital of Athens

    Athens, 115 21

  • General Hospital of Athens "Hippokration"

    Athens, 115 27

  • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

    Chaïdári, 12462

  • Euromedica - Kyanos Stavros

    Thessaloniki, 546 36

  • General Hospital of Thessaloniki "Hippokration"

    Thessaloniki, 546 42

  • 424 General Military Hospital

    Thessaloniki, 564 29

Other trials in Greece

Peru6 sites

  • Centro de Investigación del Hospital Militar Central

    Jesus Maria, 15076

  • Hospital Nacional Cayetano Heredia

    Lima, 15102

  • Unidad de Investigación de la Clinica International

    San Borja, 15036

  • Instituto Peruano del Hueso y la Articulación S.A.C. (IPHAR)

    San Isidro, 15046

  • Unidad de Investigación en Reumatología e Inmunología CSJB

    San Juan de Lurigancho, 15431

  • Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion

    Santiago de Surco, 15023

Other trials in Peru

Portugal5 sites

  • Hospital Prof. Doutor Fernando Fonseca

    Amadora, 2730-276

  • Centro Hospitalar Universitário do Algarve - Hospital de Faro

    Faro, 8000-386

  • ULS Guarda

    Guarda, 6300-749

  • Hospital Senhora Oliveira-Guimaraes

    Guimarães, 4835-044

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Serbia5 sites

  • Institute for Rheumatology, Belgrade

    Belgrade, 11000

  • Institute of Rheumatology, Belgrade

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11040

  • Special Hospital for Rheumatic Diseases, Novi Sad

    Novi Sad, 21000

Other trials in Serbia

Mexico4 sites

  • Morales Vargas Centro de Investigación S.C.

    León, 37000

  • Unidad de Atención Médica e Investigación en Salud

    Mérida, 97070

  • Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

    San Luis Potosí City, 78200

  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

    Zapopan, 45070

Other trials in Mexico

South Africa4 sites

  • Arthritis Clinical Research Trials

    Cape Town, 7405

  • Panorama Medical Centre

    Panorama, 7500

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, 2193

  • University of Pretoria

    Pretoria, 0002

Other trials in South Africa

Spain4 sites

  • Parc Taulí Sabadell University Hospital

    Sabadell, 08208

  • Clinica Gaias Santiago

    Santiago de Compostela, 15702

  • Hospital QuironSalud Sagrado Corazon

    Seville, 41013

  • Hospital Universitario Río Hortega de Valladolid

    Valladolid, 47012

Other trials in Spain

Taiwan4 sites

  • National Taiwan University Hospital

    Taipei, 100225

  • Taipei Veterans General Hospital

    Taipei, 11217

  • TRI-Service General Hospital

    Taipei, 114202

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333423

Other trials in Taiwan

Ukraine4 sites

  • Communal Non-Commercial Enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council", Cardio-Rheumatology Department

    Cherkasy, 18009

  • Medical Center LLC "Institute of Rheumatology", clinical trials department No.1

    Kyiv, 02081

  • Limited Liability Company "Medical Centre 'Consilium Medical'", Clinical and Consultation Department

    Kyiv, 04050

  • Ternopil Regional Clinical Hospital, Department of Internal Medicine No.2

    Ternopil, 46002

Other trials in Ukraine

Thailand3 sites

  • Rajavithi Hospital

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Brazil2 sites

  • LMK Servicos Medico S/S

    Porto Alegre, 90480000

  • SER - Serviços Especializados em Reumatologia da Bahia

    Salvador, 40150-150

Other trials in Brazil

Bulgaria2 sites

  • Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.

    Plovdiv, 4004

  • DCC Equita EOOD

    Varna, 9000

Other trials in Bulgaria

Czechia2 sites

  • iMedica s.r.o.

    Brno, 60200

  • Institute of Rheumatology Prague

    Prague, 128 00

Other trials in Czechia

Germany2 sites

  • Universitatsklinikum Leipzig

    Leipzig, 4103

  • Klinik für Rheumatologie und Klinische Immunologie

    Minden, 32429

Other trials in Germany

Puerto Rico2 sites

  • Centro Reumatologico de Caguas

    Caguas, 00725

  • GCM Medical Group, PSC

    San Juan, 00917

Other trials in Puerto Rico

France1 site

  • Centre Hospitalier Universitaire De La Reunion

    Saint-Denis, 97400

Other trials in France

Malaysia1 site

  • Sarawak General Hospital

    Kuching, 93586

Other trials in Malaysia

Romania1 site

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L

    Brasov, 500283

Other trials in Romania

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

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

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:

Read more
  • 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 up to 5 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 up to 5 years.

Read the 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 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.

Being tested
Cenerimod
Keywords
Skin and Connective Tissue Diseases, Connective Tissue Diseases, Immune System Diseases, Autoimmune Diseases, Musculoskeletal and connective tissue disorders
Medical subject headings
Lupus Erythematosus, Systemic, Skin and Connective Tissue Diseases, Connective Tissue Diseases, Immune System Diseases, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CenerimodDrug

    Also called ACT-334441

    Film-coated tablets at a dose of 4 mg.

Study groups in NCT06475742
Study groupRoleWhat they receive
Cenerimod 4 mgExperimentalParticipants will receive oral cenerimod once daily in addition to background systemic lupus erythematosus therapy, for up to 5 years.
Receives: Drug: Cenerimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Day 1 (post dose) to a maximum of 5.5 years

  2. 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).

    Measured: Day 1 (post dose) to a maximum of 5.5 years

  3. 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

    Measured: Day 1 (post dose) to a maximum of 5.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start30 Jul 2024
  3. Primary completionSep 2032 (estimated)
  4. Study completionSep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
680 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06475742
Sponsor's protocol ID
ID-064A303
Other IDs
2024-514354-67-00
Acronym
OPUS OLE
Status last verified
Sep 2026
First submitted
20 Jun 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cenerimod in people with Lupus Erythematosus, Systemic, run by Viatris Innovation GmbH at 122 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, Georgia, Philippines, Argentina, Colombia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent adverse events (time frame: Day 1 (post dose) to a maximum of 5.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06475742.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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