Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
- Registration Number
- NCT06475742
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 680
-
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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cenerimod 4 mg Cenerimod 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.
- Primary Outcome Measures
Name Time Method Serious adverse events Day 1 (post dose) to a maximum of 3.5 years Occurrence of serious adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).
Adverse events of special interest Day 1 (post dose) to a maximum of 3.5 years 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 malignanciesTreatment-emergent adverse events Day 1 (post dose) to a maximum of 3.5 years 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
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
Centro de Investigación del Hospital Militar Central
🇵🇪Jesus Maria, Peru
Unidad de Investigación de la Clinica International
🇵🇪San Borja, Peru
SouthCoast Research Center, Inc.
🇺🇸Miami, Florida, United States
Accurate Clinical Research Inc. - Lake Charles
🇺🇸Lake Charles, Louisiana, United States
Accurate Clinical Research Inc - (Najam)
🇺🇸Baytown, Texas, United States
Accurate Clinical Research Inc.
🇺🇸Houston, Texas, United States
Aprillus Asistencia e Investigacion
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Centro de investigaciones medicas Tucuman
🇦🇷San Miguel de Tucumán, Argentina
ICT (Investigaciones Clínicas Tucumán)
🇦🇷San Miguel de Tucumán, Argentina
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
Clinical Research Chile SpA
🇨🇱Valdivia, Chile
Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion
🇵🇪Santiago de Surco, Peru
Chong-Hua Hospital
🇵🇭Cebu City, Philippines
Lipa Medix Medical Center
🇵🇭Lipa City, Philippines
Jose R. Reyes Memorial Medical Center
🇵🇭Santa Cruz, Philippines
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
Malwa-Med Iwona Chlebicka
🇵🇱Wroclaw, Poland
GCM Medical Group, PSC
🇵🇷San Juan, Puerto Rico
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L
🇷🇴Brasov, Romania
Panorama Medical Centre
🇿🇦Panorama, South Africa
Clinica Gaias Santiago
🇪🇸Santiago de Compostela, Spain