Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Launched by NOVARTIS PHARMACEUTICALS · Nov 15, 2023

Keywords

ClinConnect Summary

This clinical trial, called the SIRIUS-SLE Extension study, is looking at the long-term safety of a treatment called ianalumab for people with systemic lupus erythematosus (SLE), a condition that can affect many parts of the body and cause various symptoms. The study is open to those who have already participated in earlier studies of ianalumab and completed their treatment. To join, participants must be 18 years or older, or if they are younger, they need permission from a parent or guardian. They should also be expected to benefit from continuing the treatment.

Participants in this trial will receive ianalumab and will be monitored for any side effects or issues over an extended period. It's important to note that certain individuals, such as those with active infections or who are pregnant or nursing, cannot participate. Additionally, men and women who could become pregnant need to agree to use effective birth control during the study and for a time afterward. Overall, this study aims to gather more information about how safe ianalumab is when used for a longer time in people with lupus.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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.
• Key Exclusion Criteria:
• • 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.
• • Other protocol-defined inclusion/exclusion criteria may apply.