Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis

Summary

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).

Timeline

Start

2015-11-04

Primary completion

2019-11-26

Completion

2021-01-18

Publications

• Almquist J, Chia YL, Tummala R, Bertagnolli L, Jayne D, Tang W, Lindholm C. Anifrolumab Dose Regimen Selection for a Phase 3 Trial in Lupus Nephritis. Clin Pharmacol Ther. 2026 May 22. doi: 10.1002/cpt.70307. Online ahead of print.
• Fava A, Petri M, Gavin PG, Csomor E, Brohawn PZ, Muthas D, Platt A, Lindholm C, Ferrari N. Anifrolumab Treatment Leads to Rapid Reduction in Urinary Biomarkers of Intrarenal Inflammation in Lupus Nephritis: Results From the Phase 2 Randomized Trial. Arthritis Rheumatol. 2026 Feb 9. doi: 10.1002/art.70089. Online ahead of print.
• Brunner HI, Cody EM, Devarajan P, Huang B, Chen C, Sinibaldi D, Ramaswamy M, Knagenhjelm J, Jones F, Brohawn PZ, Tummala R, Lindholm C, White WI. The Renal Activity Index for Lupus Identifies Active Renal Disease and Treatment Response in Adult Patients With Systemic Lupus Erythematosus and Lupus Nephritis. Arthritis Care Res (Hoboken). 2026 Jun;78(6):723-732. doi: 10.1002/acr.25684. Epub 2026 Feb 23.
• Jayne D, Rovin B, Mysler E, Furie R, Houssiau F, Trasieva T, Knagenhjelm J, Schwetje E, Tang W, Tummala R, Lindholm C. Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. Lupus Sci Med. 2023 Aug;10(2):e000910. doi: 10.1136/lupus-2023-000910.
• Jayne D, Rovin B, Mysler EF, Furie RA, Houssiau FA, Trasieva T, Knagenhjelm J, Schwetje E, Chia YL, Tummala R, Lindholm C. Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. Ann Rheum Dis. 2022 Apr;81(4):496-506. doi: 10.1136/annrheumdis-2021-221478. Epub 2022 Feb 10.

Drugs

Indications