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

Phase 3 Active not recruiting 303 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

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

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	Unknown	50 mg	—
Background	Methylprednisolone	Other / unclassified	80 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications