Clinical trial NCT06475742: Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Lupus Erythematosus, Systemic
Keywords: Skin and Connective Tissue Diseases
Connective Tissue Diseases
Immune System Diseases
Autoimmune Diseases
Musculoskeletal and connective tissue disorders
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-26
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Treatment-emergent adverse events
timeFrame: Day 1 (post dose) to a maximum of 3.5 years
measure: Serious adverse events
timeFrame: Day 1 (post dose) to a maximum of 3.5 years
measure: Adverse events of special interest
timeFrame: Day 1 (post dose) to a maximum of 3.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: SouthCoast Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers INC
state: Florida
city: Lake Charles
country: United States
facility: Accurate Clinical Research Inc. - Lake Charles
state: Louisiana
city: Baytown
country: United States
facility: Accurate Clinical Research Inc - (Najam)
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research Inc.
state: Texas
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Aprillus Asistencia e Investigacion
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Médico Arsema
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundación Respirar
city: San Miguel de Tucumán
country: Argentina
facility: Centro de investigaciones medicas Tucuman
city: San Miguel de Tucumán
country: Argentina
facility: ICT (Investigaciones Clínicas Tucumán)
city: Plovdiv
country: Bulgaria
facility: Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.
city: Varna
country: Bulgaria
facility: DCC Equita EOOD
city: Providencia
country: Chile
facility: Enroll SpA
city: Providencia
country: Chile
facility: Biomedica Research Group
city: Providencia
country: Chile
facility: Sociedad Médica del Aparato Locomotor S. A.
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA
city: Victoria
country: Chile
facility: Hospital San José de Victoria
city: Brno
country: Czechia
facility: iMedica s.r.o.
city: Prague
country: Czechia
facility: Institute of Rheumatology Prague
city: Batumi
country: Georgia
facility: LTD "New Plasma Clinic"
city: Tbilisi
country: Georgia
facility: Institute of Clinical Cardiology, Ltd
city: Tbilisi
country: Georgia
facility: LTD "Tbilisi Central Hospital"
city: Tbilisi
country: Georgia
facility: National Institute of Endocrinology Ltd.
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic Ltd.
city: Tbilisi
country: Georgia
facility: Aversi Clinic LTD
city: Tbilisi
country: Georgia
facility: Medi Club Georgia Ltd.
city: Tbilisi
country: Georgia
facility: Ltd. Mtskheta Street Clinic
city: Tbilisi
country: Georgia
facility: The First Medical Center Ltd.
city: Tbilisi
country: Georgia
facility: LLC "Innova"
city: Tbilisi
country: Georgia
facility: LTD "Tbilisi Heart Center"
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Minden
country: Germany
facility: Klinik für Rheumatologie und Klinische Immunologie
city: Athens
country: Greece
facility: General Hospital of Athens "Hippokration"
city: Thessaloniki
country: Greece
facility: Euromedica - Kyanos Stavros
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Hippokration"
city: Jesus Maria
country: Peru
facility: Centro de Investigación del Hospital Militar Central
city: San Borja
country: Peru
facility: Unidad de Investigación de la Clinica International
city: Santiago de Surco
country: Peru
facility: Investigaciones Clinicas / Instituto de Ginecologa y Reproduccion
city: Cebu City
country: Philippines
facility: Chong-Hua Hospital
city: Lipa City
country: Philippines
facility: Lipa Medix Medical Center
city: Santa Cruz
country: Philippines
facility: Jose R. Reyes Memorial Medical Center
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Katowice
country: Poland
facility: Vita Longa Sp. z o.o.
city: Poznan
country: Poland
facility: Medyczne Centrum Hetmanska
city: Wroclaw
country: Poland
facility: Malwa-Med Iwona Chlebicka
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L
city: Belgrade
country: Serbia
facility: Institute of Rheumatology, Belgrade
city: Novi Sad
country: Serbia
facility: Special Hospital for Rheumatic Diseases, Novi Sad
city: Panorama
country: South Africa
facility: Panorama Medical Centre
city: Santiago de Compostela
country: Spain
facility: Clinica Gaias Santiago
city: Sevilla
country: Spain
facility: Hospital QuironSalud Sagrado Corazon
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: