NCT02550652

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil/Mycophenolic Acid	MMF/MPA will be administered as per schedule specified in the respective arm.
DRUG	Obinutuzumab	Obinutuzumab will be administered as per schedule specified in the respective arm.
OTHER	Placebo	Placebo matching to obinutuzumab will be administered as per schedule specified in the respective arm.
DRUG	Methylprednisolone	Methylprednisolone IV will be administered as per schedule specified in the respective arm.
DRUG	Prednisone	Prednisone will be administered as per schedule specified in the respective arm.

Timeline

• Start date: 2015-11-13
• Primary completion: 2019-01-15
• Completion: 2023-08-02
• First posted: 2015-09-15
• Last updated: 2024-08-27
• Results posted: 2020-02-26

Locations

46 sites across 12 countries: United States, Argentina, Brazil, Colombia, Costa Rica, France, Israel, Italy, Mexico, Panama, Peru, Spain