clinical trial · NCT04963296
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
Hoffmann-La Roche·phase3·active not recruiting·n = 303
Systemic Lupus ErythematosusObinutuzumabPlaceboAcetaminophen/ParacetamolDiphenhydramine hydrochlorideMethylprednisolone
brief 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.
started
Oct 26, 2021
primary completion
Sep 15, 2025
completion
Mar 14, 2028
last updated
Apr 6, 2026
official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol