Clinical Trials in Poland / NCT06475742
Enrolling by invitation
Phase 3
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
NCT06475742 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Lupus Erythematosus, Systemic
Investigational drug(s) / intervention(s)
Cenerimod: Film-coated tablets at a dose of 4 mg.
Study 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 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.
Eligibility
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).
Primary outcome measure(s)
- Treatment-emergent adverse events — Day 1 (post dose) to a maximum of 5.5 years
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). - Serious adverse events — Day 1 (post dose) to a maximum of 5.5 years
Occurrence of serious adverse events up to the final study visit (maximum 5 years of study treatment plus 6-month safety follow-up period). - Adverse events of special interest — Day 1 (post dose) to a maximum of 5.5 years
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
Trial sites (122)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | |
| Omega Research MetroWest, LLC | DeBary | Florida | |
| SouthCoast Research Center, Inc. | Miami | Florida | |
| Allied Biomedical Research Institute | Miami | Florida | |
| D&H National Research Centers INC | Miami | Florida | |
| Professional research Center INC | Miami | Florida | |
| San Marcus Res Clin Inc. | Miami Lakes | Florida | |
| Accurate Clinical Research Inc. - Lake Charles | Lake Charles | Louisiana | |
| RB Wellness Clinic | Las Vegas | Nevada | |
| Accurate Clinical Research Inc - (Najam) | Baytown | Texas | |
| Novel Research LLC | Bellaire | Texas | |
| Accurate Clinical Research Inc. | Houston | Texas | |
| Sun Research | San Antonio | Texas | |
| 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 | |
| SER - Serviços Especializados em Reumatologia da Bahia | Salvador | 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 | |
| Clínica de la costa S.A.S. | Barranquilla | Colombia | |
| IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán) | Bogotá | Colombia | |
| Servimed S.A.S | Bucaramanga | Colombia | |
| Centro de Estudios de Reumatología y Dermatología | Cali | Colombia | |
| Preventive Care SAS | Chía | Colombia | |
| Hospital Pablo Tobon Uribe | Medellín | Colombia | |
| Healthy Medical Center SAS | Zipaquirá | Colombia | |
| iMedica s.r.o. | Brno | Czechia |
+ 82 more sites — see the full list on the official registry below.
More Viatris Innovation GmbH trials in Poland
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Active, not recruiting
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Enrolling by invitation
Other trials for the same condition
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
Active, not recruiting
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06475742 on ClinicalTrials.gov ↗ ← All trials in Poland