Recruiting
Phase 3

Remibrutinib

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

Aug, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Mar 30, 2029

Anticipated

Eligibility Criteria

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

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

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

Arkansas Childrens Hosp Rsch Inst

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Erin Thomas

+1 501 978 6413ThomasES@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 9050viviennean@calallergy.com

Principal Investigator:

Ricardo Tan

Respiratory Medicine Research Institute of Michigan

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Diana Grigoryan

+1 734 434 3007dgrigoryan@annarborallergy.com

Principal Investigator:

Jeffrey G Leflein

National Allergy and Asthma Research LLS

Recruiting

North Charleston, South Carolina, United States, 29420

Contacts

Faye Singleton

+1 843 820 1036fsingleton@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

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 2, 2026

Last verified

Aug, 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 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-02.