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A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

NCT04221477 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2026-05-11

Study results available
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Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

Conditions

Interventions

DRUG

Obinutuzumab

Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.

DRUG

MMF

MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.

DRUG

Prednisone

Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.

DRUG

Placebo

Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.

DRUG

Methylprednisolone

Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.

DRUG

Acetaminophen

Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

DRUG

Diphenhydramine

Diphenhydramine 50 mg will be administered as premedication prior to infusions.

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
2020-08-10
Primary Completion
2024-08-15
Completion
2031-03-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Colombia
  • France
  • Germany
  • Israel
  • Italy
  • Mexico
  • Peru
  • Poland
  • Russia
  • South Africa
  • Spain
  • United Kingdom

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 NCT04221477 on ClinicalTrials.gov