NCT04963296

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
DRUG	Placebo	Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.
DRUG	Acetaminophen/Paracetamol	Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
DRUG	Diphenhydramine hydrochloride	Diphenhydramine 50 mg will be administered as premedication prior to infusions.
DRUG	Methylprednisolone	Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.

Timeline

• Start date: 2021-10-26
• Primary completion: 2025-09-15
• Completion: 2028-03-14
• First posted: 2021-07-15
• Last updated: 2026-04-06

Locations

64 sites across 14 countries: United States, Argentina, Brazil, Czechia, France, Italy, Mexico, New Zealand, Peru, Poland, Russia, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study