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

NCT04963296 PHASE3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Hoffmann-La Roche
Phase	PHASE3
Status	ACTIVE_NOT_RECRUITING
Enrolment	303
Start date	Tue Oct 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Mar 14 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Systemic Lupus Erythematosus

Interventions

• Obinutuzumab
• Placebo
• Acetaminophen/Paracetamol
• Diphenhydramine hydrochloride
• Methylprednisolone

Countries

France, Italy, New Zealand, Russia, South Africa, Peru, United Kingdom, Poland, Mexico, Argentina, Spain, United States, Brazil, Czechia