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NCT06369467 · ClinicalTrials.gov registry record · Phase 1

Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy

A Phase 1 study of Food Allergy, sponsored by Regeneron Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
6
Enrollment target
7
Study locations

NCT06369467 is a Phase 1 study of Food Allergy that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 6 participants, below the 964-participant average among 17 other Food Allergy trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 6 states.

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The verdict

NCT06369467, a Phase 1 study of Food Allergy, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
6 participants
Enrollment target
7
Study locations

Study Summary

This study is researching an experimental drug called linvoseltamab combined with another drug called dupilumab. The study is looking at patients who have severe IgE-mediated food allergy. If the patient has an allergy, the body's defense system (immune system) overreacts to an allergen (eg, certain foods like peanuts, milk, shellfish) by making antibodies called IgE. An antibody is a protein that allows the immune system to find and fight off things the body does not recognize (allergens). IgE antibodies are sent out by cells like plasma cells. These antibodies and allergens bind to other cells that send out chemicals, causing an allergic reaction. The aim of the study is to see what side effects happen when linvoseltamab is combined with dupilumab. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * Does linvoseltamab combined with dupilumab affect other types of antibodies in the blood at different times * How much study drug(s) is in the blood at different times

Conditions Studied

Food Allergy

Interventions

  • DRUG dupilumab
  • DRUG linvoseltamab

Study Locations (7)

Other

  • Clinica Universidad de Navarra - Madrid - Madrid
  • Clinica Universidad de Navarra- Pamplona - Pamplona

Florida

  • University of South Florida - Tampa

Georgia

  • Emory University- Winship Cancer Institute - Atlanta

Massachusetts

  • Massachusetts General Hospital - Boston

New York

  • Icahn School of Medicine at Mount Sinai - New York

Pennsylvania

  • The Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2024-05-17
Est. Completion 2028-03-28
Phase Phase 1

Sponsor

Regeneron Pharmaceuticals

280 total trials

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What the Registry Record Tells You About NCT06369467

The ClinicalTrials.gov registry entry for NCT06369467 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 964-participant average among 17 other Food Allergy trials with a reported enrollment target (99% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Food Allergy appearing as the primary indexed condition, and to 2 interventions - of which dupilumab is the first listed.

NCT06369467 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Other, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06369467 about?

NCT06369467 is a clinical study titled "Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy". This study is researching an experimental drug called linvoseltamab combined with another drug called dupilumab. The study is looking at patients who have severe IgE-mediated food allergy. If the patient has an allergy, the body's defense system (immune system) overreacts to an allergen (eg, certain...

What is the current status of trial NCT06369467?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2024-05-17. Estimated completion is 2028-03-28.

What conditions does trial NCT06369467 study?

This clinical trial studies the following conditions: Food Allergy.

What interventions are being tested in trial NCT06369467?

The interventions under investigation include: dupilumab (DRUG), linvoseltamab (DRUG).

Who is sponsoring clinical trial NCT06369467?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06369467 being conducted?

This trial has 7 study locations across Florida, Georgia, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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