A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
Public ClinicalTrials.gov record NCT04963296. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04963296
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 303 participants
Conditions and interventions
Conditions
Interventions
- Obinutuzumab Drug
- Placebo Drug
- Acetaminophen/Paracetamol Drug
- Diphenhydramine hydrochloride Drug
- Methylprednisolone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 26, 2021 (Actual)
- Primary completion
- Sep 15, 2025 (Actual)
- Completion
- Mar 13, 2028 (Estimated)
- Last update posted
- May 14, 2026
2021 – 2028
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | — |
| Unity Health - White County Medical Center- Rheumatology | Searcy | Arkansas | 72143 | — |
| Providence Medical Foundation | Fullerton | California | 92835 | — |
| Arthritis & Rheumatism | Aventura | Florida | 33180 | — |
| Great Lakes Center of Rheumatology | Lansing | Michigan | 48911 | — |
| Clinical Research Institute of Michigan, LLC | Troy | Michigan | 48047 | — |
| Northwell Health Division of Rheumatology | Great Neck | New York | 11021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Joint & Muscle Research Institute | Charlotte | North Carolina | 28204 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43212 | — |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | 44130 | — |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | — |
| Texas Arthritis Center | El Paso | Texas | 79902 | — |
| Prolato Clinical Research Center | Houston | Texas | 77054 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 50 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04963296, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 14, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04963296 live on ClinicalTrials.gov.