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New lupus drug tested for Long-Term safety in 680 patients

NCT ID NCT06475742

Disease control Sponsor: Viatris Innovation GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study looks at the long-term safety of cenerimod in adults with moderate-to-severe lupus. About 680 participants who were in a previous study will take cenerimod for up to 3 years, along with their usual lupus medications. Researchers will track side effects and see how well the drug controls lupus symptoms over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 680 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

autoimmune disease connective tissue disorder immune system disorder Skin and Connective Tissue Diseases systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus erythematosus, systemic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    122 sites in 26 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 424 General Military Hospital

    Thessaloniki, 564 29, Greece

  • Accurate Clinical Research Inc - (Najam)

    Baytown, Texas, 77521, United States

  • Accurate Clinical Research Inc.

    Houston, Texas, 77089, United States

  • Accurate Clinical Research Inc. - Lake Charles

    Lake Charles, Louisiana, 70605, United States

  • Allied Biomedical Research Institute

    Miami, Florida, 33155, United States

  • Aprillus Asistencia e Investigacion

    Buenos Aires, 1406, Argentina

  • Arthritis Clinical Research Trials

    Cape Town, 7405, South Africa

  • Aversi Clinic LTD

    Tbilisi, 0160, Georgia

  • Biomedica Research Group

    Providencia, 7500710, Chile

  • Centre Hospitalier Universitaire De La Reunion

    Saint-Denis, 97400, France

  • Centro Hospitalar Universitário do Algarve - Hospital de Faro

    Faro, 8000-386, Portugal

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

    Vila Nova de Gaia, 4434-502, Portugal

  • Centro Médico Arsema

    Buenos Aires, 1416, Argentina

  • Centro Reumatologico de Caguas

    Caguas, 00725, Puerto Rico

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

    San Luis Potosí City, 78200, Mexico

  • Centro de Especialidades Medicas Vanguardia

    Temuco, 4810345, Chile

  • Centro de Estudios de Reumatología y Dermatología

    Cali, 760042, Colombia

  • Centro de Investigación del Hospital Militar Central

    Jesus Maria, 15076, Peru

  • Centro de investigaciones medicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

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

    Brasov, 500283, Romania

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611, Poland

  • Centrum Medyczne Pratia Częstochowa

    Częstochowa, 42-217, Poland

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, 2193, South Africa

  • Chong-Hua Hospital

    Cebu City, 6000, Philippines

  • Clinica Gaias Santiago

    Santiago de Compostela, 15702, Spain

  • Clinical Research Chile SpA

    Valdivia, 5110683, Chile

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765, United States

  • Clínica de la costa S.A.S.

    Barranquilla, 080020, Colombia

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

    Cherkasy, 18009, Ukraine

  • D&H National Research Centers INC

    Miami, Florida, 33155, United States

  • DCC Equita EOOD

    Varna, 9000, Bulgaria

  • Davao Doctors Hospital

    Davao City, 8000, Philippines

  • Enroll SpA

    Providencia, 7500588, Chile

  • Euromedica - Kyanos Stavros

    Thessaloniki, 546 36, Greece

  • Far Eastern University - Nicanor Reyes Medical Foundation

    Quezon City, 1118, Philippines

  • Fundación Respirar

    Buenos Aires, 1426, Argentina

  • GCM Medical Group, PSC

    San Juan, 00917, Puerto Rico

  • General Hospital of Athens "Hippokration"

    Athens, 115 27, Greece

  • General Hospital of Thessaloniki "Hippokration"

    Thessaloniki, 546 42, Greece

  • Healthy Medical Center SAS

    Zipaquirá, 250252, Colombia

  • Hospital Nacional Cayetano Heredia

    Lima, 15102, Peru

  • Hospital Pablo Tobon Uribe

    Medellín, 050034, Colombia

  • Hospital Prof. Doutor Fernando Fonseca

    Amadora, 2730-276, Portugal

  • Hospital QuironSalud Sagrado Corazon

    Seville, 41013, Spain

  • Hospital San José de Victoria

    Victoria, 4720000, Chile

  • Hospital Senhora Oliveira-Guimaraes

    Guimarães, 4835-044, Portugal

  • Hospital Universitario Río Hortega de Valladolid

    Valladolid, 47012, Spain

  • ICT (Investigaciones Clínicas Tucumán)

    San Miguel de Tucumán, T4000ICL, Argentina

  • IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)

    Bogotá, 110221, Colombia

  • IR Medical Center S.A.

    Mendoza, 5500, Argentina

  • Iloilo Doctors Hospital

    Iloilo City, 5000, Philippines

  • Institute for Rheumatology, Belgrade

    Belgrade, 11000, Serbia

  • Institute of Clinical Cardiology, Ltd

    Tbilisi, 0159, Georgia

  • Institute of Rheumatology Prague

    Prague, 128 00, Czechia

  • Institute of Rheumatology, Belgrade

    Belgrade, 11000, Serbia

  • Instituto CAICI SRL

    Rosario, S2000PBJ, Argentina

  • Instituto Medico CER

    Quilmes, B1878DVB, Argentina

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

    San Isidro, 15046, Peru

  • Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion

    Santiago de Surco, 15023, Peru

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

    Zapopan, 45070, Mexico

  • Jose R. Reyes Memorial Medical Center

    Santa Cruz, 1003/1014, Philippines

  • Klinik für Rheumatologie und Klinische Immunologie

    Minden, 32429, Germany

  • LLC "Innova"

    Tbilisi, 0186, Georgia

  • LMK Servicos Medico S/S

    Porto Alegre, 90480000, Brazil

  • LTD "New Plasma Clinic"

    Batumi, 6010, Georgia

  • LTD "Tbilisi Central Hospital"

    Tbilisi, 0159, Georgia

  • LTD "Tbilisi Heart Center"

    Tbilisi, 0186, Georgia

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

    Kyiv, 04050, Ukraine

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333423, Taiwan

  • Lipa Medix Medical Center

    Lipa City, 4217, Philippines

  • Ltd. Mtskheta Street Clinic

    Tbilisi, 0179, Georgia

  • Makati Medical Center

    Makati, 1229, Philippines

  • Malwa-Med Iwona Chlebicka

    Wroclaw, 50-304, Poland

  • Medi Club Georgia Ltd.

    Tbilisi, 0160, Georgia

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

    Kyiv, 02081, Ukraine

  • Medyczne Centrum Hetmanska

    Poznan, 60-218, Poland

  • Military Medical Academy

    Belgrade, 11040, Serbia

  • Morales Vargas Centro de Investigación S.C.

    León, 37000, Mexico

  • National Institute of Endocrinology Ltd.

    Tbilisi, 0159, Georgia

  • National Taiwan University Hospital

    Taipei, 100225, Taiwan

  • Naval Hospital of Athens

    Athens, 115 21, Greece

  • Novel Research LLC

    Bellaire, Texas, 77401, United States

  • Omega Research MetroWest, LLC

    DeBary, Florida, 32713, United States

  • Ospital ng Makati

    Makati, 1642, Philippines

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

    Plovdiv, 4004, Bulgaria

  • Panorama Medical Centre

    Panorama, 7500, South Africa

  • Parc Taulí Sabadell University Hospital

    Sabadell, 08208, Spain

  • Preventive Care SAS

    Chía, 250001, Colombia

  • Professional research Center INC

    Miami, Florida, 33172, United States

  • RB Wellness Clinic

    Las Vegas, Nevada, 89102, United States

  • Rajavithi Hospital

    Bangkok, 10400, Thailand

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • SER - Serviços Especializados em Reumatologia da Bahia

    Salvador, 40150-150, Brazil

  • San Marcus Res Clin Inc.

    Miami Lakes, Florida, 33014, United States

  • Sarawak General Hospital

    Kuching, 93586, Malaysia

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Servimed S.A.S

    Bucaramanga, 680003, Colombia

  • Sociedad Médica del Aparato Locomotor S. A.

    Providencia, 7510186, Chile

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • SouthCoast Research Center, Inc.

    Miami, Florida, 33136, United States

  • Special Hospital for Rheumatic Diseases, Novi Sad

    Novi Sad, 21000, Serbia

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

    Sampaloc, 1015, Philippines

  • St Lukes Medical Center

    Quezon City, 1102, Philippines

  • Sun Research

    San Antonio, Texas, 78215, United States

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

    Bydgoszcz, 85-168, Poland

  • TRI-Service General Hospital

    Taipei, 114202, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tbilisi Heart and Vascular Clinic Ltd.

    Tbilisi, 0159, Georgia

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

    Ternopil, 46002, Ukraine

  • The First Medical Center Ltd.

    Tbilisi, 0180, Georgia

  • Twoja Przychodnia Poznańskie Centrum Medyczne

    Poznan, 60-324, Poland

  • ULS Guarda

    Guarda, 6300-749, Portugal

  • Unidad de Atención Médica e Investigación en Salud

    Mérida, 97070, Mexico

  • 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

  • Universitatsklinikum Leipzig

    Leipzig, 4103, Germany

  • University Clinical Center of Serbia

    Belgrade, 11000, Serbia

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

    Chaïdári, 12462, Greece

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Pretoria

    Pretoria, 0002, South Africa

  • Vita Longa Sp. z o.o.

    Katowice, 40-748, Poland

  • iMedica s.r.o.

    Brno, 60200, Czechia

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