Phase 2 Study of Iptacopan Added to Standard Treatment for Adults With Active Lupus Nephritis Classes III-IV, With or Without Class V

What this Trial Is About

Researchers are evaluating iptacopan LNP023 alongside standard care to study its effectiveness, safety, and tolerability in adults with active lupus nephritis Class III-IV, with or without Class V. This phase 2 trial is randomized, double-blind, and placebo-controlled, aiming to explore dosing and treatment outcomes in this patient group. Participants receive either iptacopan combined with standard care, placebo matching iptacopan with standard care, or iptacopan with placebo as part of the standard care. Each treatment is taken for 52 weeks. The study proceeds in two parts, with different combination regimens of iptacopan, placebo, and standard care, including oral corticosteroids or their absence. During the study, participants undergo assessments at baseline and weeks 24 and 52 to measure kidney response, protein levels in urine, fatigue, and lupus disease activity using specific scoring tools. Researchers monitor the proportion of patients achieving complete renal response without flares and other kidney and health outcomes. Safety and tolerability are also evaluated over the course of treatment and follow-up.

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V