A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

Summary

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

Timeline

Start

2015-11-13

Primary completion

2019-01-15

Completion

2023-08-02

Outcome

Met primary endpoint

registry OBINUTUZUMAB 1000MG and MMF vs PLACEBO and MMF; p = 0.1145; Difference in Percentage of Participants 12.3 (95% CI -3.4 to 28.1) NCT02550652 ↗

registry Statistically significant at pre-specified alpha of 20%. NCT02550652 ↗

release “The study met the primary endpoint with Gazyva” gene.com ↗

Publications

• Rovin BH, Furie RA, Ross Terres JA, Giang S, Schindler T, Turchetta A, Garg JP, Pendergraft WF 3rd, Malvar A. Kidney Outcomes and Preservation of Kidney Function With Obinutuzumab in Patients With Lupus Nephritis: A Post Hoc Analysis of the NOBILITY Trial. Arthritis Rheumatol. 2024 Feb;76(2):247-254. doi: 10.1002/art.42734. Epub 2023 Nov 10.
• Furie RA, Aroca G, Cascino MD, Garg JP, Rovin BH, Alvarez A, Fragoso-Loyo H, Zuta-Santillan E, Schindler T, Brunetta P, Looney CM, Hassan I, Malvar A. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-107. doi: 10.1136/annrheumdis-2021-220920. Epub 2021 Oct 6.
• Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obinutuzumab	Monoclonal antibody	1000 mg	Intravenous
Background	Methylprednisolone	Other / unclassified	750 mg	Intravenous
Background	Methylprednisolone	Other / unclassified	1000 mg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	2000 mg	Oral
Background	Mycophenolate Mofetil	Small molecule	2500 mg	Oral
Background	Prednisone	Other / unclassified	7.5 mg	Oral
Background	mycophenolic acid	Small molecule	1440 mg	Oral
Background	mycophenolic acid	Small molecule	1800 mg	Oral

Indications