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NCT07768371PHASE3Recruiting

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

Novartis Pharmaceuticals

Start Date

8/27/2026

Completion Date

12/31/2029

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.

Detailed Description

This study is a Phase III, 52-week, multi-center, placebo controlled pivotal study to evaluate the efficacy and safety of remibrutinib compared to placebo in adolescent and adult participants with peanut, milk, or egg IgE-mediated allergy. This study will be conducted in 4 Sub-studies: Sub-study 1 to evaluate response to peanut allergen at Week 24, Sub-study 2 to evaluate response to milk allergen at Week 24, Sub-study 3 to evaluate response to egg allergen at Week 24, and Sub-study 4 to evaluate response to peanut or milk, or egg allergen at Week 4. Treatment period 1: Participants will receive one of the two treatment groups, double-blind remibrutinib or placebo, for a period up to 24 weeks for Sub-studies 1, 2, and 3, and up to 4 weeks for Sub-study 4. Treatment period 2: For all Sub-studies, the open label period starts at Week 24, except for Sub-study 4, where the open label period starts at Week 4. Participants from each Sub-study will continue in the study and receive, or initiate, active open label remibrutinib until Week 52. Following completion of the treatment period 2, eligible participants may enroll in a separate open-label post-trial access study and receive remibrutinib to evaluate long-term treatment effects. Participants who do not enroll in the post-trial access study will enter a 4-week safety follow-up period off treatment, during which adverse events will be monitored.

Eligibility Criteria

Age Range: 12 years to 65 years

Inclusion Criteria: * Signed informed consent and/or assent (where applicable) must be obtained prior to study participation. Participant (and parent/legal guardian for adolescents) must be able to understand and provide informed consent and assent, as applicable. If a minor participant providing assent reaches the age of legal majority (as defined by local law), he/she must be re-consented (ICF) at the next study visit. * Male or female participants who are 12 to 65 years of age, inclusive, at the time of signing informed consent/assent. * Positive allergen-specific (peanut, milk, or egg), IgE (≥ 0.35 kUA/L) at Screening Visit 1. * Positive Skin Prick Testing (SPT) for peanut, milk, or egg at Screening Visit 1. This is defined as the average diameter (longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to the negative control. * A positive DBPCFC at baseline (Screening Visit 2), defined as the occurrence of dose-limiting symptoms at a single dose: * ≤ 100 mg of peanut allergen protein * ≤ 300 mg for milk or egg allergen protein * Participants must be able and willing to participate in the DBPCFC and must be willing to continue avoiding exposure to peanut, milk (cooked and uncooked), or egg (cooked and uncooked) and any other foods that they are allergic to throughout this study. Exclusion Criteria: * Previous use of remibrutinib or other Bruton Tyrosine Kinase (BTK) inhibitors. * History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes. * Hypersensitivity or intolerance to any of the matrix components used within the material for the DBPCFC. * Any occurrence of dose-limiting symptoms against placebo allergen at baseline DBPCFC (Screening Visit Part 1 and/or Part 2). * Medical examination, medical conditions or laboratory findings that, in the opinion of the investigator, renders the participant unsuitable for the study. Other protocol-defined inclusion/exclusion criteria may apply.

Interventions

DRUG

Remibrutinib

DRUG

Placebo

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Conditions

IgE-Mediated Food AllergyPeanut AllergyCow Milk AllergyEgg Allergy

Locations

AllerVie Clinical Research-Homewood

Birmingham, Alabama 35209

United States

Medical Resch of Arizona-Div of Allergy Asthma and Immunology

Scottsdale, Arizona 85251

United States

Arkansas Childrens Hosp Rsch Inst

Little Rock, Arkansas 72202

United States

California Allergy and Asthma Medical Group

Los Angeles, California 90025

United States

Asthma and Allergy Associates P C

Colorado Springs, Colorado 80907

United States

Childrens Healthcare Of Atlanta

Atlanta, Georgia 30329

United States

Sneeze Wheeze Itch Asso LLC

Normal, Illinois 61761

United States

Asthma and Allergy Center of Chicago S C

River Forest, Illinois 60305

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Institute for Asthma and Allergy PC

Chevy Chase, Maryland 20815

United States

Childrens Hosp Boston Dept of Heme

Boston, Massachusetts 02115

United States

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan 48197

United States

Impact Medical - Circuit Clinical

Riverdale, New Jersey 07457

United States

Northwell Health

New York, New York 10028

United States

Montefiore Health System

The Bronx, New York 10461

United States

National Allergy and Asthma Research LLS

North Charleston, South Carolina 29420

United States

Western Sky Medical Research

El Paso, Texas 79924

United States

Allergy Associates of Utah

Sandy City, Utah 84093

United States