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

NCT ID: NCT06475742

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2028-05-31

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.

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.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cenerimod

Intervention Type: DRUG

Film-coated tablets at a dose of 4 mg.

Interventions

Cenerimod

Film-coated tablets at a dose of 4 mg.

Intervention Type: DRUG

Other Intervention Names

ACT-334441

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viatris Innovation GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Viatris Innovation GmbH

Locations

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Omega Research MetroWest, LLC

DeBary, Florida, United States

SouthCoast Research Center, Inc.

Miami, Florida, United States

D&H National Research Centers INC

Miami, Florida, United States

San Marcus Res Clin Inc.

Miami Lakes, Florida, United States

Accurate Clinical Research Inc. - Lake Charles

Lake Charles, Louisiana, United States

RB Wellness Clinic

Las Vegas, Nevada, United States

Accurate Clinical Research Inc - (Najam)

Baytown, Texas, United States

Novel Research LLC

Bellaire, Texas, United States

Accurate Clinical Research Inc.

Houston, Texas, United States

Aprillus Asistencia e Investigacion

Buenos Aires, , Argentina

Centro Médico Arsema

Buenos Aires, , Argentina

Fundación Respirar

Buenos Aires, , Argentina

IR Medical Center S.A.

Mendoza, , Argentina

Instituto Medico CER

Quilmes, , Argentina

Instituto CAICI SRL

Rosario, , Argentina

Centro de investigaciones medicas Tucuman

San Miguel de Tucumán, , Argentina

ICT (Investigaciones Clínicas Tucumán)

San Miguel de Tucumán, , Argentina

LMK Servicos Medico S/S

Porto Alegre, , Brazil

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

Plovdiv, , Bulgaria

DCC Equita EOOD

Varna, , Bulgaria

Enroll SpA

Providencia, , Chile

Biomedica Research Group

Providencia, , Chile

Sociedad Médica del Aparato Locomotor S. A.

Providencia, , Chile

Centro de Especialidades Medicas Vanguardia

Temuco, , Chile

Clinical Research Chile SpA

Valdivia, , Chile

Hospital San José de Victoria

Victoria, , Chile

iMedica s.r.o.

Brno, , Czechia

Institute of Rheumatology Prague

Prague, , Czechia

LTD "New Plasma Clinic"

Batumi, , Georgia

Institute of Clinical Cardiology, Ltd

Tbilisi, , Georgia

LTD "Tbilisi Central Hospital"

Tbilisi, , Georgia

National Institute of Endocrinology Ltd.

Tbilisi, , Georgia

Tbilisi Heart and Vascular Clinic Ltd.

Tbilisi, , Georgia

Aversi Clinic LTD

Tbilisi, , Georgia

Medi Club Georgia Ltd.

Tbilisi, , Georgia

Ltd. Mtskheta Street Clinic

Tbilisi, , Georgia

The First Medical Center Ltd.

Tbilisi, , Georgia

LLC "Innova"

Tbilisi, , Georgia

LTD "Tbilisi Heart Center"

Tbilisi, , Georgia

Universitatsklinikum Leipzig

Leipzig, , Germany

Klinik für Rheumatologie und Klinische Immunologie

Minden, , Germany

General Hospital of Athens "Hippokration"

Athens, , Greece

Euromedica - Kyanos Stavros

Thessaloniki, , Greece

General Hospital of Thessaloniki "Hippokration"

Thessaloniki, , Greece

424 General Military Hospital

Thessaloniki, , Greece

Centro de Investigación del Hospital Militar Central

Jesus Maria, , Peru

Unidad de Investigación de la Clinica International

San Borja, , Peru

Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion

Santiago de Surco, , Peru

Chong-Hua Hospital

Cebu City, , Philippines

Lipa Medix Medical Center

Lipa City, , Philippines

Makati Medical Center

Makati, , Philippines

Ospital ng Makati

Makati, , Philippines

St Lukes Medical Center

Quezon City, , Philippines

Far Eastern University - Nicanor Reyes Medical Foundation

Quezon City, , Philippines

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

Sampaloc, , Philippines

Jose R. Reyes Memorial Medical Center

Santa Cruz, , Philippines

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

Bydgoszcz, , Poland

Centrum Medyczne Pratia Częstochowa

Częstochowa, , Poland

Centrum Medyczne Angelius Provita

Katowice, , Poland

Vita Longa Sp. z o.o.

Katowice, , Poland

Medyczne Centrum Hetmanska

Poznan, , Poland

Twoja Przychodnia Poznańskie Centrum Medyczne

Poznan, , Poland

Malwa-Med Iwona Chlebicka

Wroclaw, , Poland

Hospital Prof. Doutor Fernando Fonseca

Amadora, , Portugal

Centro Hospitalar Universitário do Algarve - Hospital de Faro

Faro, , Portugal

ULS Guarda

Guarda, , Portugal

Hospital Senhora Oliveira-Guimaraes

Guimarães, , Portugal

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

Vila Nova de Gaia, , Portugal

Centro Reumatologico de Caguas

Caguas, , Puerto Rico

GCM Medical Group, PSC

San Juan, , Puerto Rico

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

Brasov, , Romania

Institute of Rheumatology, Belgrade

Belgrade, , Serbia

University Clinical Center of Serbia

Belgrade, , Serbia

Special Hospital for Rheumatic Diseases, Novi Sad

Novi Sad, , Serbia

Panorama Medical Centre

Panorama, , South Africa

Charlotte Maxeke Johannesburg Academic Hospital

Parktown, , South Africa

Seoul National University Hospital

Seoul, , South Korea

Parc Taulí Sabadell University Hospital

Sabadell, , Spain

Clinica Gaias Santiago

Santiago de Compostela, , Spain

Hospital QuironSalud Sagrado Corazon

Seville, , Spain

Hospital Universitario Río Hortega de Valladolid

Valladolid, , Spain

Taipei Veterans General Hospital

Taipei, , Taiwan

TRI-Service General Hospital

Taipei, , Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Countries

United States; Argentina; Brazil; Bulgaria; Chile; Czechia; Georgia; Germany; Greece; Peru; Philippines; Poland; Portugal; Puerto Rico; Romania; Serbia; South Africa; South Korea; Spain; Taiwan

Other Identifiers

2024-514354-67-00

Identifier Type: CTIS

Identifier Source: secondary_id

ID-064A303

Identifier Type: -

Identifier Source: org_study_id