Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

A pill that could outsmart food allergies? trial tests remibrutinib

NCT ID NCT07768371

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Sep 17, 2026 · Updated 8 times

Summary

This Phase 3 study is testing whether an oral drug called remibrutinib can help people with IgE-mediated allergies to peanuts, cow's milk, or hen's egg tolerate larger amounts of the allergen without symptoms. Adults and adolescents aged 12 to 65 will receive either the drug or a placebo for up to 52 weeks. The main goal is to see if more participants can eat a predefined amount of the allergen during a food challenge without a reaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remibrutinib (LOU064), an oral drug
What this could lead to
If successful, this could lead to a daily pill that raises the amount of peanut, milk, or egg a person can eat without an allergic reaction, potentially reducing the risk from accidental exposure.
What could go wrong
The trial is still in progress, and results may not confirm benefit. The drug may cause side effects, and the effect could vary by allergen or person.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 576 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cow milk allergy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Egg Hypersensitivity food allergy Heiner syndrome Milk Hypersensitivity Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cow milk allergy Egg allergy IgE-mediated food allergy Peanut allergy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allervie Clinical Research

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • Arkansas Childrens Hosp Rsch Inst

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • California Allergy and Asthma Medical Group

    RECRUITING

    Los Angeles, California, 90025, United States

  • Institute for Asthma and Allergy PC

    RECRUITING

    Chevy Chase, Maryland, 20815, United States

  • Medical Resch of Arizona-Div of Allergy Asthma and Immunology

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • National Allergy and Asthma Research LLS

    RECRUITING

    North Charleston, South Carolina, 29420, United States

  • Northwell Health

    RECRUITING

    New York, New York, 10028, United States

  • Respiratory Medicine Research Institute of Michigan

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Weiss Medical

    RECRUITING

    Riverdale, New Jersey, 07457, United States

  • Western Sky Medical Research

    RECRUITING

    El Paso, Texas, 79924, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.