Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cenerimod.
- Who it may be relevant to
- Registry conditions: Lupus Erythematosus, Systemic. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Brazil, Bulgaria, Chile +21
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- Drug Cenerimod
Film-coated tablets at a dose of 4 mg.
Primary outcome measures
- Treatment-emergent adverse events [Time frame: Day 1 (post dose) to a maximum of 5.5 years]
- Serious adverse events [Time frame: Day 1 (post dose) to a maximum of 5.5 years]
- Adverse events of special interest [Time frame: Day 1 (post dose) to a maximum of 5.5 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 14 centers
- University of Colorado Denver — Aurora
- Clinical Research of West Florida, Inc. — Clearwater
- Omega Research MetroWest, LLC — DeBary
- SouthCoast Research Center, Inc. — Miami
- Allied Biomedical Research Institute — Miami
- D&H National Research Centers INC — Miami
- Professional research Center INC — Miami
- San Marcus Res Clin Inc. — Miami Lakes
- … and 6 more centers
Georgia · 11 centers
- LTD "New Plasma Clinic" — Batumi
- Institute of Clinical Cardiology, Ltd — Tbilisi
- LTD "Tbilisi Central Hospital" — Tbilisi
- National Institute of Endocrinology Ltd. — Tbilisi
- Tbilisi Heart and Vascular Clinic Ltd. — Tbilisi
- Aversi Clinic LTD — Tbilisi
- Medi Club Georgia Ltd. — Tbilisi
- Ltd. Mtskheta Street Clinic — Tbilisi
- … and 3 more centers
Philippines · 10 centers
- Chong-Hua Hospital — Cebu City
- Davao Doctors Hospital — Davao City
- Iloilo Doctors Hospital — Iloilo City
- Lipa Medix Medical Center — Lipa City
- Makati Medical Center — Makati
- Ospital ng Makati — Makati
- St Lukes Medical Center — Quezon City
- Far Eastern University - Nicanor Reyes Medical Foundation — Quezon City
- … and 2 more centers
Argentina · 8 centers
- Aprillus Asistencia e Investigacion — Buenos Aires
- Centro Médico Arsema — Buenos Aires
- Fundación Respirar — Buenos Aires
- IR Medical Center S.A. — Mendoza
- Instituto Medico CER — Quilmes
- Instituto CAICI SRL — Rosario
- Centro de investigaciones medicas Tucuman — San Miguel de Tucumán
- ICT (Investigaciones Clínicas Tucumán) — San Miguel de Tucumán
Colombia · 7 centers
- Clínica de la costa S.A.S. — Barranquilla
- IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán) — Bogotá
- Servimed S.A.S — Bucaramanga
- Centro de Estudios de Reumatología y Dermatología — Cali
- Preventive Care SAS — Chía
- Hospital Pablo Tobon Uribe — Medellín
- Healthy Medical Center SAS — Zipaquirá
Poland · 7 centers
Center list to be confirmed — check the primary protocol.
Chile · 6 centers
- Enroll SpA — Providencia
- Biomedica Research Group — Providencia
- Sociedad Médica del Aparato Locomotor S. A. — Providencia
- Centro de Especialidades Medicas Vanguardia — Temuco
- Clinical Research Chile SpA — Valdivia
- Hospital San José de Victoria — Victoria
Greece · 6 centers
- Naval Hospital of Athens — Athens
- General Hospital of Athens "Hippokration" — Athens
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara — Chaïdári
- Euromedica - Kyanos Stavros — Thessaloniki
- General Hospital of Thessaloniki "Hippokration" — Thessaloniki
- 424 General Military Hospital — Thessaloniki
Peru · 6 centers
- Centro de Investigación del Hospital Militar Central — Jesus Maria
- Hospital Nacional Cayetano Heredia — Lima
- Unidad de Investigación de la Clinica International — San Borja
- Instituto Peruano del Hueso y la Articulación S.A.C. (IPHAR) — San Isidro
- Unidad de Investigación en Reumatología e Inmunología CSJB — San Juan de Lurigancho
- Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion — Santiago de Surco
Portugal · 5 centers
Center list to be confirmed — check the primary protocol.
Serbia · 5 centers
Center list to be confirmed — check the primary protocol.
Mexico · 4 centers
- Morales Vargas Centro de Investigación S.C. — León
- Unidad de Atención Médica e Investigación en Salud — Mérida
- Centro de Atención e Investigación Cardiovascular del Potosí, S.C. — San Luis Potosí City
- Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. — Zapopan
South Africa · 4 centers
Center list to be confirmed — check the primary protocol.
Spain · 4 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Ukraine · 4 centers
Center list to be confirmed — check the primary protocol.
Thailand · 3 centers
Center list to be confirmed — check the primary protocol.
Brazil · 2 centers
- LMK Servicos Medico S/S — Porto Alegre
- SER - Serviços Especializados em Reumatologia da Bahia — Salvador
Bulgaria · 2 centers
- Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh — Plovdiv
- DCC Equita EOOD — Varna
Czechia · 2 centers
- iMedica s.r.o. — Brno
- Institute of Rheumatology Prague — Prague
Germany · 2 centers
- Universitatsklinikum Leipzig — Leipzig
- Klinik für Rheumatologie und Klinische Immunologie — Minden
Puerto Rico · 2 centers
Center list to be confirmed — check the primary protocol.
France · 1 center
- Centre Hospitalier Universitaire De La Reunion — Saint-Denis
Malaysia · 1 center
- Sarawak General Hospital — Kuching
Romania · 1 center
Center list to be confirmed — check the primary protocol.
South Korea · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06475742 · ID-064A303 · 2024-514354-67-00