A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

Summary

This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

Timeline

Start

2021-10-26

Primary completion

2025-09-15

Completion

2028-03-13

Outcome

Met primary endpoint

paper treatment with obinutuzumab was superior to placebo with respect to the primary and all key secondary end points. PMID 41789864 ↗

release “Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva” gene.com ↗

release “Phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint” gene.com ↗

Publications

• Furie RA, Dall'Era M, Vital EM, Garg JP, Irazoque Palazuelos F, Zuta Santillan AE, Ravelo-Hernandez J, Santiago MB, Zazueta Montiel B, Botha S, Leszczynski P, de Souza VA, Sicsik SA, Bellatin L, Naidoo A, Amoura Z, D'Agostino MA, Kumar S, Workeneh B, Rae J, Mao HA, Erblang F, Meier O, Maller JC, Askanase AD; ALLEGORY Trial Investigators. Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2026 Mar 6. doi: 10.1056/NEJMoa2516150. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obinutuzumab	Monoclonal antibody	1000 mg	Intravenous
Background	Acetaminophen	Small molecule	650 mg	—
Background	Acetaminophen	Small molecule	1000 mg	—
Background	Diphenhydramine	Small molecule	50 mg	—
Background	Methylprednisolone	Other / unclassified	80 mg	Intravenous

Indications