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RecruitingPhase 3NCT07768371

A 52-week Study of Remibrutinib in IgE-mediated Food Allergy

A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy and Safety of Remibrutinib (LOU064) in Adult and Adolescent Participants With IgE-mediated Food Allergy

Sponsor

Novartis Pharmaceuticals

Enrollment

576 participants

Start Date

Aug 27, 2026

Study Type

INTERVENTIONAL

Conditions

Egg allergyIgE-mediated food allergyPeanut allergyCow Milk Allergy

Summary

The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk ("milk", cooked and uncooked) or hen's egg ("egg", cooked and uncooked) immunoglobulin E (IgE)- mediated allergy in comparison to placebo.

Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Remibrutinib for people with cow milk allergy, egg allergy, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 12 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemibrutinib

Oral administration of remibrutinib.

DRUGPlacebo

Oral administration of placebo.

Locations(8)

Allervie Clinical Research

Birmingham, Alabama, United States

Arkansas Childrens Hosp Rsch Inst

Little Rock, Arkansas, United States

California Allergy and Asthma Medical Group

Los Angeles, California, United States

Institute for Asthma and Allergy PC

Chevy Chase, Maryland, United States

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan, United States

Weiss Medical

Riverdale, New Jersey, United States

National Allergy and Asthma Research LLS

North Charleston, South Carolina, United States

Western Sky Medical Research

El Paso, Texas, United States

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NCT07768371

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