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NCT04221477 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Lupus Nephritis, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 3
Development phase
271
Enrollment target
20
Study locations

NCT04221477 is a Phase 3 study of Lupus Nephritis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 271 participants, below the 301-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT04221477, a Phase 3 study of Lupus Nephritis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
271 participants
Enrollment target
20
Study locations

Study 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 Studied

Lupus Nephritis

Interventions

  • DRUG Obinutuzumab
  • DRUG Placebo
  • DRUG Prednisone
  • DRUG Methylprednisolone
  • DRUG MMF

Study Locations (20)

California

  • Wallace Rheumatic Study Center - Beverly Hills
  • Kaiser Permanente - Fontana - Fontana
  • Kaiser Permanente - San Francisco Medical Center - San Francisco
  • Stanford University Medical Center - Stanford

New York

  • North Shore University Hospital - Manhasset
  • NYU Langone Medical Center - New York
  • Columbia University Medical Center - New York
  • AD-CARE, University of Rochester Medical Center - Rochester

Texas

  • University of Texas Southwestern - Dallas
  • Southwest Rheumatology - Mesquite

Other

  • Organizacion Medica de Investigacion - Buenos Aires
  • DOM Centro de Reumatología - Buenos Aires

Alabama

  • University of Alabama at Birmingham Medical Center - Birmingham

Colorado

  • Univ Colorado Health Sci Ctr - Aurora

Connecticut

  • Yale Medical Group - New Haven

Florida

  • University of Miami Miller School of Medicine - Miami

Trial Details

FieldValue
Enrollment Target 271 participants
Start Date 2020-08-10
Est. Completion 2031-02-28
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT04221477

The ClinicalTrials.gov registry entry for NCT04221477 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 271 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 301-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (10% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 5 interventions - of which Obinutuzumab is the first listed.

NCT04221477 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, New York, Texas.

Frequently Asked Questions

What is clinical trial NCT04221477 about?

NCT04221477 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis". 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 mycop...

What is the current status of trial NCT04221477?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 271 participants. The study started on 2020-08-10. Estimated completion is 2031-02-28.

What conditions does trial NCT04221477 study?

This clinical trial studies the following conditions: Lupus Nephritis.

What interventions are being tested in trial NCT04221477?

The interventions under investigation include: Obinutuzumab (DRUG), Placebo (DRUG), Prednisone (DRUG), Methylprednisolone (DRUG), MMF (DRUG).

Who is sponsoring clinical trial NCT04221477?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04221477 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.