NCT05268289

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

Detailed description

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Iptacopan (part 1)	Taken for 52 Weeks
DRUG	Iptacopan (part 2)	Taken for 52 Weeks
DRUG	Placebo + standard of care	Taken for 52 Weeks
DRUG	Iptacopan + placebo	Taken for 52 Weeks

Timeline

• Start date: 2022-08-10
• Primary completion: 2026-03-30
• Completion: 2028-09-28
• First posted: 2022-03-07
• Last updated: 2026-03-20

Locations

103 sites across 20 countries: United States, Argentina, Brazil, China, Colombia, France, Germany, Hong Kong, Hungary, India, Israel, Malaysia, Mexico, Philippines, Portugal, Puerto Rico, Singapore, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study