Extension Study to Assess Long-Term Safety of Ianalumab in Adolescents and Adults With Systemic Lupus Erythematosus

What this Trial Is About

Researchers are evaluating the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus SLE who have previously completed treatment in one of two core SIRIUS-SLE studies. This Phase 3 extension study compares monthly or quarterly subcutaneous ianalumab to monthly placebo in participants who are positive for anti-nuclear antibodies ANA. The study aims to understand how ianalumab performs over an extended period in this patient group. Participants receive ianalumab either monthly or quarterly via subcutaneous injection, or a monthly placebo injection, throughout the extension study. Only those who completed the initial 60-week treatment period of the core studies without discontinuation are eligible. The study involves random assignment to one of the three groups and follows a quadruple-blind design to ensure unbiased results. During the trial, participants are monitored for treatment-emergent adverse events and serious adverse events up to approximately 91 months. Researchers also assess lupus disease activity, damage progression, corticosteroid use, and flare rates. Safety and tolerability are closely observed through regular evaluations, with the study lasting until April 2032, allowing for comprehensive long-term data collection.

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