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

NCT02550652 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-08-27

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-13
Primary Completion
2019-01-15
Completion
2023-08-02

Countries

  • United States
  • Argentina
  • Brazil
  • Colombia
  • Costa Rica
  • France
  • Israel
  • Italy
  • Mexico
  • Panama
  • Peru
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02550652 on ClinicalTrials.gov