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

NCT07768371 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CLOU064I123012024-519159-28-00
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 14

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Sub-study 1: Number of participants achieving response status (tolerated at least 600 mg of peanut protein)

  Response status is defined as tolerating an oral dose of at least 600 mg peanut protein (1044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).

  Week 24

• Sub-study 2: Number of participants achieving response status (tolerated at least 1000 mg of milk protein)

  Response status is defined as tolerating an oral dose of at least 1000 mg milk protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).

  Week 24

• Sub-study 3: Number of participants achieving response status (tolerated at least 1000 mg of egg protein)

  Response status is defined as tolerating an oral dose of at least 1000 mg egg protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).

  Week 24

Secondary Outcomes (16)

• Sub-study 1: Number of participants achieving response status (tolerated at least 1000 mg of peanut protein)

  Week 24

• Sub-study 1: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose of peanut protein

  Baseline and Week 24

• Sub-study 2: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose of milk protein

  Baseline and Week 24

• Sub-study 3: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose of egg protein

  Baseline and Week 24

• Sub-study 1: Number of participants by Maximum Symptom Severity During Peanut Protein Challenge

  Week 24

Study Arms (8)

Sub-study 1- LOU064

EXPERIMENTAL

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.

Drug: Remibrutinib; Drug: Placebo

Sub-study 1- Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Sub-study 2- LOU064

EXPERIMENTAL

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.

Drug: Remibrutinib; Drug: Placebo

Sub-study 2- Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Sub-study 3- LOU064

EXPERIMENTAL

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.

Drug: Remibrutinib; Drug: Placebo

Sub-study 3- Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Sub-study 4- LOU064

EXPERIMENTAL

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.

Drug: Remibrutinib; Drug: Placebo

Sub-study 4- Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Placebo DRUG

Oral administration of placebo.

Sub-study 1- LOU064; Sub-study 1- Placebo; Sub-study 2- LOU064; Sub-study 2- Placebo; Sub-study 3- LOU064; Sub-study 3- Placebo; Sub-study 4- LOU064; Sub-study 4- Placebo

Remibrutinib DRUG

Oral administration of remibrutinib.

Also known as: LOU064

Sub-study 1- LOU064; Sub-study 2- LOU064; Sub-study 3- LOU064; Sub-study 4- LOU064

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (14)

Allervie Clinical Research

Birmingham, Alabama, 35209, United States

RECRUITING

Medical Resch of Arizona-Div of Allergy Asthma and Immunology

Scottsdale, Arizona, 85251, United States

RECRUITING

Arkansas Childrens Hosp Rsch Inst

Little Rock, Arkansas, 72202, United States

RECRUITING

California Allergy and Asthma Medical Group

Los Angeles, California, 90025, United States

RECRUITING

Childrens Healthcare Of Atlanta

Atlanta, Georgia, 30329, United States

RECRUITING

Sneeze Wheeze Itch Asso LLC

Normal, Illinois, 61761, United States

RECRUITING

Asthma and Allergy Center of Chicago S C

River Forest, Illinois, 60305, United States

RECRUITING

Institute for Asthma and Allergy PC

Chevy Chase, Maryland, 20815, United States

RECRUITING

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan, 48197, United States

RECRUITING

Weiss Medical

Riverdale, New Jersey, 07457, United States

RECRUITING

Northwell Health

New York, New York, 10028, United States

RECRUITING

Montefiore Health System

The Bronx, New York, 10461, United States

RECRUITING

National Allergy and Asthma Research LLS

North Charleston, South Carolina, 29420, United States

RECRUITING

Western Sky Medical Research

El Paso, Texas, 79924, United States

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Milk Hypersensitivity; Egg Hypersensitivity

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: August 27, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (14)