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Recruiting Phase 3 Interventional

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

ClinicalTrials.gov ID: NCT07438496

Public ClinicalTrials.gov record NCT07438496. 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.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 1:03 AM EDT

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 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

Study identification

NCT ID
NCT07438496
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
600 participants

Conditions and interventions

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
Mar 4, 2026
Primary completion
Dec 5, 2028
Completion
Nov 6, 2031
Last update posted
Aug 27, 2026

2026 – 2031

United States locations

U.S. sites
36
U.S. states
13
U.S. cities
35
Facility City State ZIP Site status
David S Hallegua MD A Professional Corporation Beverly Hills California 90211 Recruiting
Providence Medical Foundation Fullerton California 92835 Recruiting
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis Hemet California 92543 Recruiting
Advanced Medical Research La Palma California 90623 Recruiting
Medvin Clinical Research San Leandro San Leandro California 94578 Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California 90502 Recruiting
Solace Clinical Research California Tustin California 92780 Recruiting
Inland Rheumatology Clinical Trials Inc. Upland California 91786 Recruiting
Arthritis & Rheumatic Disease Specialties Aventura Florida 33180 Recruiting
Clinical Research of West Florida 1 Clearwater Florida 33765 Recruiting
Avanti Clinical Research Corp Hialeah Florida 33013 Recruiting
LeJenue Research Associates PLLC Miami Florida 33126 Recruiting
Pro-Care Research Center, Corp. Miami Gardens Florida 33014 Recruiting
Floridian Clinical Research LLC Miami Lakes Florida 33016 Recruiting
Integral Rheumatology And Immunology Specialists Plantation Florida 33324 Recruiting
Clinical Research of West Florida Tampa Florida 33606 Recruiting
Atlanta Research Center for Rheumatology Marietta Georgia 30060 Recruiting
Willow Rheumatology and Wellness PLLC Willowbrook Illinois 60527 Recruiting
Accurate Clinical Research, Inc. Lake Charles Louisiana 70605 Recruiting
Revive Research Institute Sterling Heights Michigan 48313 Recruiting
Rutgers New Jersey Medical School Newark New Jersey 07103 Recruiting
Arthritis Rheumatic And Back Disease Associates Voorhees Township New Jersey 08043 Recruiting
Joint and Muscle Research Institute Charlotte North Carolina 28204 Recruiting
DJL Clinical Research, PLLC Charlotte North Carolina 28211 Recruiting
Cross Creek Medical Clinic Fayetteville North Carolina 28304 4422 Recruiting
Paramount Medical Research & Consulting Middleburg Heights Ohio 44130 Recruiting
Clinical Research Philadelphia Philadelphia Pennsylvania 19114 Recruiting
West Tennessee Research Institute Jackson Tennessee 38305 Recruiting
Amarillo Center for Clinical Research Amarillo Texas 79124 Recruiting
Arthritis and Rheumatology Research Institute Frisco Texas 75035 Recruiting
R and H Clinical Research Katy Texas 77449 Recruiting
Southwest Rheumatology Research LLC Mesquite Texas 75150 Recruiting
Texas Rheumatology Research Institute LLC Plano Texas 75024 Recruiting
Epic Medical Research 1 Red Oak Texas 75154 Recruiting
Fort Bend Rheumatology Associates PLLC Sugar Land Texas 77479 Recruiting
Carilion Clinic Virginia Tech Carilion School of Medicine Roanoke Virginia 24011 Recruiting

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 213 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07438496, 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 Aug 27, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07438496 live on ClinicalTrials.gov.

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