A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06133972Tipo: INTERVENTIONALInicio: 21 de may de 2024Fin estimado: 5 de abr de 2032

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

Descripción detallada

The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.

Criterios de exclusión

Use of prohibited therapies.
Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
Plans for administration of live vaccines during the study period.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.

Intervenciones

drug

Placebo

Placebo s.c. monthly

drug

Ianalumab

Ianalumab s.c. monthly Ianalumab s.c. quarterly

Ubicaciones

Novartis Investigative Site

San Miguel, Buenos Aires, Argentina

RECRUITING

Novartis Investigative Site

San Miguel, Tucumán Province, Argentina

RECRUITING

Novartis Investigative Site

Caba, Argentina

RECRUITING

Novartis Investigative Site

San Miguel de Tucumán, Argentina

RECRUITING

Patrocinadores

PrincipalNovartis Pharmaceuticals

Contactos

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com 1-888-669-6682

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com +41613241111

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