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RECRUITING Phase 3

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

NCT07438496 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • DRUG Placebo
  • DRUG Nipocalimab
  • DRUG Standard of care treatment

Study Locations (5)

California

  • Advanced Medical Research — La Palma

Florida

  • Clinical Research of West Florida — Tampa

North Carolina

  • Joint and Muscle Research Institute — Charlotte

Ohio

  • Paramount Medical Research & Consulting — Middleburg Heights

Pennsylvania

  • Clinical Research Philadelphia — Philadelphia

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2026-03-05
Est. Completion 2031-11-07
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07438496

The ClinicalTrials.gov registry entry for NCT07438496 describes a study currently listed as 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 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 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 Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT07438496 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, North Carolina. 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 NCT07438496 about?

NCT07438496 is a clinical study titled "A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus". 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...

What is the current status of trial NCT07438496?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2026-03-05. Estimated completion is 2031-11-07.

What conditions does trial NCT07438496 study?

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

What interventions are being tested in trial NCT07438496?

The interventions under investigation include: Placebo (DRUG), Nipocalimab (DRUG), Standard of care treatment (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07438496?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07438496 being conducted?

This trial has 5 study locations across California, Florida, North Carolina, Ohio, Pennsylvania. 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