Novartis terminates Phase 2 iptacopan lupus nephritis trial after Part 1

Novartis Pharmaceuticals has stopped its Phase 2 trial of iptacopan, also known as LNP023, in patients with active lupus nephritis, according to the study record on ClinicalTrials.gov (NCT05268289). The record lists the trial's overall status as terminated and states that the decision to conclude the study after Part 1 LPLV is based on strategic considerations by the Sponsor.¹ The record does not specify any safety or efficacy findings as reasons for the decision.

The trial, formally titled "An Adaptive, Randomized, Double-blind, Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2 Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in Combination With Standard-of-care With and Without Oral Corticosteroids in Patients With Active Lupus Nephritis Class III-IV, +/- V," began on August 10, 2022, according to the actual start date listed. Primary completion is listed as March 19, 2026, and study completion as October 1, 2026, with the record first posted on March 7, 2022, and last updated on October 15, 2026.¹

The study enrolled 81 participants and was designed to test iptacopan in addition to standard of care across a randomized, quadruple-masked, sequential design¹ in patients with biopsy-proven lupus nephritis. Iptacopan was administered for 52 weeks across both Part 1 and Part 2 arms.¹ The primary outcome measured the proportion of patients achieving Complete Renal Response at week 24 in the absence of renal flares.¹ The trial had been running at 74 sites in 19 countries, including the United States, Argentina, Brazil, China, and several European and Asian nations.¹