Novartis’ Phase 2 study of iptacopan for active lupus nephritis is listed as terminated, closing a trial that tested the drug alongside standard treatment for the kidney complication of lupus.
The study, registered as NCT05268289, was organized in two parts. ClinicalTrials.gov updated its status to terminated Thursday, Oct. 15. According to the registry, strategic considerations drove the sponsor’s decision to conclude the study after the last participant in Part 1 completed their last visit.
The study was designed to assess iptacopan’s effects in patients receiving standard care, including safety and tolerability. The registry identifies the study drug as iptacopan (LNP023); the U.S. Food and Drug Administration’s prescribing information identifies it as Fabhalta, an oral complement Factor B inhibitor. The registry’s objectives covered the treatment’s benefits, risks and how well patients tolerated it.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) describes lupus nephritis as kidney disease caused by lupus. The registry says the study focused on patients with active disease.
