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NCT04963296 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
A Phase 3 study of Systemic Lupus Erythematosus, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 303
- Enrollment target
- 20
- Study locations
NCT04963296: Active Phase 3 study of Systemic Lupus Erythematosus, sponsored by Hoffmann-La Roche.
NCT04963296 is a Phase 3 study of Systemic Lupus Erythematosus that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 303 participants, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04963296, a Phase 3 study of Systemic Lupus Erythematosus, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 303 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
SRI(4) requires reduction from baseline of \>=4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), no new systems or organs affected, as defined by \>=1 new British Isles Lupus Assessment Group (BILAG) A or \>=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of \>=0.30 points on a 3-point Physician's Global Assessment Visual Analogue Scale (PGA-VAS).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2021-10-26 |
| Est. Completion | 2028-03-14 |
| Phase | Phase 3 |
What the registry record for NCT04963296 still lists
NCT04963296 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (20% lower).
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.
NCT04963296 names 20 study sites across 12 states, led by Texas, Other, Michigan.
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.
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).
Who is sponsoring clinical trial NCT04963296?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04963296's enrollment target sits among peer trials
303 29th of 99 higher than 71 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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