Novartis Launches Phase III Trial of Pill That Could Help Protect Against Reactions

Pharmaceutical giant Novartis is recruiting teenagers and adults with peanut, milk, or egg allergies for a large, international clinical trial of an experimental oral medication called remibrutinib (LOU064). The Phase III study, registered as NCT07768371, will investigate whether the medication can increase the amount of an allergen a person can tolerate before experiencing a reaction. If successful, the treatment could eventually provide an additional layer of protection against accidental food allergen exposure.

Unlike oral immunotherapy (OIT), which involves consuming gradually increasing amounts of an allergen to build tolerance, remibrutinib works by interfering with the body’s allergic response. The drug blocks an enzyme called Bruton’s tyrosine kinase (BTK), which helps activate immune cells involved in allergic reactions. By blocking this enzyme, researchers hope to reduce the release of chemicals that cause symptoms such as hives, swelling, difficulty breathing, and potentially life-threatening anaphylaxis.

The study is divided into four smaller investigations, each designed to answer a different question. The first three will evaluate how well remibrutinib works against peanut, cow’s milk, and hen’s egg allergies after 24 weeks of treatment. The fourth will investigate whether the medication can begin providing protection in as little as four weeks. If researchers can demonstrate that it works this quickly, remibrutinib could offer a different approach from treatments that require months of gradual allergen exposure.

Participants will initially be randomly assigned to receive either remibrutinib or a placebo, an inactive pill, without knowing which treatment they are taking. In the first three sub-studies, this comparison lasts up to 24 weeks; in the fourth, it lasts up to four weeks. Participants who continue into the next phase will receive remibrutinib through Week 52, allowing researchers to gather additional information about its effectiveness and safety. Eligible participants may also have the opportunity to enter a separate follow-up study to evaluate longer-term treatment effects.

To qualify, volunteers must be between 12 and 65 years old and have a confirmed allergy to peanuts, cow’s milk, or eggs. Researchers will use skin prick tests and blood tests to assess allergic sensitivity. Participants must also undergo a carefully supervised food challenge confirming that they react to 100 milligrams or less of peanut protein, or 300 milligrams or less of milk or egg protein. These small amounts help researchers identify participants who are particularly sensitive to their allergens and measure whether treatment increases the amount they can tolerate.

Importantly, participants must continue avoiding their allergens throughout the trial. Remibrutinib is being investigated as an additional layer of protection against accidental exposure, not as a way to make allergenic foods safe to eat freely. It is also not an emergency treatment for anaphylaxis and would not replace epinephrine. Because the medication is experimental for food allergies, researchers must determine both its benefits and potential side effects. People who have previously taken remibrutinib or other BTK inhibitors are excluded from participating.

The trial plans to enroll 576 participants and began in August 2026, with an estimated completion date of December 2029. Study locations include major medical institutions across the United States, such as Johns Hopkins Hospital, Boston Children’s Hospital, and Montefiore Health System, along with international research centers. Although it is too early to know whether remibrutinib will prove effective, the prospect of a pill that could increase protection against accidental exposure represents an intriguing direction in food allergy treatment. Researchers will be watching closely to learn how much protection it provides, how quickly it begins working, and whether it can be used safely over time.

Interested in joining this clinical trial? Click here for more information.