Recruiting

Phase 3

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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07768371

Conditions

IgE-Mediated Food Allergy

Peanut Allergy

Cow Milk Allergy

Egg Allergy

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

Interventions

Remibrutinib

Placebo

Study Details

Brief 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.

Conditions

IgE-Mediated Food Allergy

Peanut Allergy

Cow Milk Allergy

Egg Allergy

Study ID

NCT07768371

Start date

Aug 27, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Mar 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

576 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sub-study 1- LOU064

Participants with peanut allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.

placebo comparator: Sub-study 1- Placebo

Participants with peanut allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.

experimental: Sub-study 2- LOU064

Participants with cow's milk allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.

placebo comparator: Sub-study 2- Placebo

Participants with cow's milk allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.

experimental: Sub-study 3- LOU064

Participants with hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.

placebo comparator: Sub-study 3- Placebo

Participants with hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.

experimental: Sub-study 4- LOU064

Participants with peanut, cow's milk, and hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52.

placebo comparator: Sub-study 4- Placebo

Participants with peanut, cow's milk, and hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52.

Interventions

Remibrutinib

Oral administration of remibrutinib.

Placebo

Oral administration of placebo.

Primary outcome measure

Sub-study 1: Number of participants achieving response status (tolerated at least 600 mg of peanut protein) [ Time Frame: Week 24 ]
Sub-study 2: Number of participants achieving response status (tolerated at least 1000 mg of milk protein) [ Time Frame: Week 24 ]
Sub-study 3: Number of participants achieving response status (tolerated at least 1000 mg of egg protein) [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

Locations

AllerVie Clinical Research-Homewood

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Esther Patterson Lange

+1 205 871 9661 elange@allervie.com

Principal Investigator:

Weily Soong

Medical Resch of Arizona-Div of Allergy Asthma and Immunology

Recruiting

Scottsdale, Arizona, United States, 85251

Contacts

Jasmine Hernandez

+1 480 889 6313 jas@medicalresearchaz.com

Principal Investigator:

Michael E Manning

Arkansas Childrens Hosp Rsch Inst

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Erin Thomas

+1 501 978 6413 ThomasES@archildrens.org

Principal Investigator:

Amy Scurlock

California Allergy and Asthma Medical Group

Recruiting

Los Angeles, California, United States, 90025

Contacts

Vivienne An

+1 310 966 9050 viviennean@calallergy.com

Principal Investigator:

Ricardo Tan

Asthma and Allergy Associates P C

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

Sneha Tata

+1 719 473 8330 STata@aacos.com

Principal Investigator:

Daniel Soteres

Childrens Healthcare Of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Ashley Dulson

Ashley.Dulson@choa.org

Principal Investigator:

Brian Vickery

Sneeze Wheeze Itch Asso LLC

Recruiting

Normal, Illinois, United States, 61761

Contacts

Stephanie Oliver

stephanieoliver@asthma2.com

Principal Investigator:

Dareen D Siri

Asthma and Allergy Center of Chicago S C

Recruiting

River Forest, Illinois, United States, 60305

Contacts

Emily Rodriguez

emily@asthmaallergycenterofchicago.com

Principal Investigator:

Rachna Shah

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Gledson Hanelt

ghanelt1@jhu.edu

Principal Investigator:

Robert Wood

Institute for Asthma and Allergy PC

Recruiting

Chevy Chase, Maryland, United States, 20815

Contacts

Amy Tran

iaaresearchatran@gmail.com

Principal Investigator:

Huamin Henry Li

Childrens Hosp Boston Dept of Heme

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sidney Wang

+1 617 355 7700 sidney.wang@childrens.harvard.edu

Principal Investigator:

Rima Rachid

Respiratory Medicine Research Institute of Michigan

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Diana Grigoryan

+1 734 434 3007 dgrigoryan@annarborallergy.com

Principal Investigator:

Jeffrey G Leflein

Impact Medical - Circuit Clinical

Recruiting

Riverdale, New Jersey, United States, 07457

Contacts

Melba Ventura

mventura@circuitclinical.com

Principal Investigator:

Jeffrey Weiss

Northwell Health

Recruiting

New York, New York, United States, 10028

Contacts

Aaqil Ali

+1 516 622 5064 aali27@northwell.edu

Principal Investigator:

Sherry Farzan

Montefiore Health System

Recruiting

The Bronx, New York, United States, 10461

Contacts

Patricia Pallo

ppallor@montefiore.org

Principal Investigator:

Punita Ponda

National Allergy and Asthma Research LLS

Recruiting

North Charleston, South Carolina, United States, 29420

Contacts

Faye Singleton

+1 843 820 1036 fsingleton@nationalallergyandent.com

Principal Investigator:

Patricia Gerber

Western Sky Medical Research

Recruiting

El Paso, Texas, United States, 79924

Contacts

Laura Herrera

lherrera@westernskymed.com

Principal Investigator:

Todd Funkhouser

Allergy Associates of Utah

Recruiting

Sandy City, Utah, United States, 84093

Contacts

Rylee Roper

+1 801 263 8700 rylee.roper@utahallergies.com

Principal Investigator:

Andrew M Smith

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

IgE-mediated food allergy,
peanut allergy,
milk allergy,
egg allergy,
remibrutinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.