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ACTIVE NOT RECRUITING Phase 3

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

NCT04963296 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Obinutuzumab
  • DRUG Placebo
  • DRUG Methylprednisolone
  • DRUG Acetaminophen/Paracetamol
  • DRUG Diphenhydramine hydrochloride

Study Locations (20)

Texas

  • Precision Comprehensive Clinical Research Solutions — Colleyville
  • Texas Arthritis Center — El Paso
  • Prolato Clinical Research Center — Houston

Other

  • Organizacion Medica de Investigacion — Buenos Aires
  • DOM Centro de Reumatología — Buenos Aires
  • Centro de Investigaciones Médicas Tucuman — San Miguel

Michigan

  • Great Lakes Center of Rheumatology — Lansing
  • Clinical Research Institute of Michigan, LLC — Troy

New York

  • Northwell Health Division of Rheumatology — Great Neck
  • Columbia University Medical Center — New York

Ohio

  • The Ohio State University Wexner Medical Center — Columbus
  • Paramount Medical Research & Consulting, LLC — Middleburg Heights

Minas Gerais

  • Hospital das Clinicas - UFMG — Belo Horizonte
  • Santa Casa de Misericordia — Belo Horizonte

Alabama

  • Pinnacle Research Group — Anniston

Arkansas

  • Unity Health - White County Medical Center- Rheumatology — Searcy

Trial Details

FieldValue
Enrollment Target 303 participants
Start Date 2021-10-26
Est. Completion 2028-03-14
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04963296

The ClinicalTrials.gov registry entry for NCT04963296 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 5 interventions — of which Obinutuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04963296 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, Other, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04963296 about?

NCT04963296 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus". 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.

What is the current status of trial NCT04963296?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 303 participants. The study started on 2021-10-26. Estimated completion is 2028-03-14.

What conditions does trial NCT04963296 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04963296?

The interventions under investigation include: Obinutuzumab (DRUG), Placebo (DRUG), Methylprednisolone (DRUG), Acetaminophen/Paracetamol (DRUG), Diphenhydramine hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04963296?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04963296 being conducted?

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

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial