A Phase 3 trial of the remibrutinib pill in teens and adults with milk, egg or peanut allergy is underway. The medication is already approved to treat chronic hives.
The new trial will evaluate whether remibrutinib also protects against food allergy reactions after one month or six months of daily use.
Novartis, the drugmaker, calls it a “pivotal” study. Pivotal Phase 3 clinical trials are large-scale studies used to establish whether a drug is safe and effective enough for FDA approval for a particular use.
The trial, which launched in August 2026, aims to enroll 576 participants ages 12 to 65 at eight food allergy centers in Alabama, Arkansas, California, Maryland, Michigan, New Jersey, South Carolina and Texas.
The Phase 3 trial includes four sub-studies. Three will evaluate how well remibrutinib pills protect against reactions to peanut, milk or egg after six months. A fourth sub-study will test remibrutinib’s effectiveness in protecting against allergic reactions to any of the three allergens after one month of use.
Dr. Robert Wood, who led an earlier study on remibrutinib for food allergy, has previously said the medication could potentially be used to treat any food allergy, not just the allergens being tested. Wood is director of pediatric allergy and immunology at Johns Hopkins Children’s Center.
Pill for Food Allergies: Trial Design
Participants must have an allergy to peanut, milk or egg. This will be confirmed by a food challenge before the study begins. At the initial challenge, participants need to react to 100 milligrams (mg) or less of peanut protein. For milk or egg protein, they must react to 300 mg or less.
In three sub-studies, participants will be randomly assigned to receive either daily remibrutinib, or a placebo, for 24 weeks. They will then undergo another food challenge to see whether they can tolerate more of their allergen without significant symptoms of a reaction.
Researchers will consider participants responders if they can consume at least 600 mg of peanut protein, 1,000 mg of milk protein or 1,000 mg of egg protein before a significant reaction. That’s roughly the amount of protein in 2½ peanuts, two tablespoons of milk, or one-sixth of an egg. Food challenges can go as high as 3,000 mg of peanut, egg and milk protein.
Afterward, participants can continue into an open-label extension. During it, everyone, including those who initially received the placebo, will receive remibrutinib through one year.
The fourth sub-study will test whether remibrutinib is protective against reactions after just one month. Those participants will take either remibrutinib or a placebo daily for four weeks, and then undergo a food challenge. They too will continue into an open-label extension and receive remibrutinib through one year.
The study is expected to be completed by the end of 2029.
Blocking the Allergy Response
Remibrutinib was approved by the FDA in September 2025 to treat adults with chronic spontaneous urticaria (CSU) that’s not well-controlled by antihistamines. Sold under the brand name Rhapsido, the medication is a highly selective Bruton’s tyrosine kinase (BTK) inhibitor.
BTK is a signaling enzyme that activates mast cells and basophils during IgE-mediated allergic reactions. When activated, these immune cells release histamine and other inflammatory molecules. This causes symptoms such as itching, hives, swelling and potentially, anaphylaxis.
Remibrutinib prevents BTK from becoming activated, interrupting an important part of the pathway that triggers allergic reactions.
Remibrutinib: Promising Phase 2 Results
An earlier, Phase 2 study of remibrutinib in 59 peanut-allergic adults showed promising results. After four weeks of treatment, 84 percent of participants taking 100 mg of remibrutinib could tolerate at least 600 mg of peanut protein without significant allergic symptoms.
Researchers also tested 10 mg and 25 mg doses, as well as a placebo. After four weeks, about 41 percent of participants taking 10 mg could tolerate at least 600 mg of peanut protein. At 25 mg, about 52 percent could tolerate that amount. No one in the placebo group could tolerate 600 mg.
“This was a dose-related effect,” said Wood, who led the study. As the dose escalated, “there was clearly a higher success rate.”
The study also included one group who received a 25 mg dose for just one week. Of those, 88 percent tolerated at least 600 mg of peanut protein during the food challenge. This “suggests this drug has a very rapid onset,” Wood said.
There were no serious adverse events, and the drug was well-tolerated.
Approved for Chronic Hives
In the Phase 3 trials that led to its approval for chronic hives, remibrutinib significantly reduced itching and hives by 12 weeks. Some participants saw improvements within one week. After one year, nearly half were symptom-free.
People with chronic urticaria typically take 25 mg twice a day. Novartis has not shared the dosing frequency or amount being tested in the Phase 3 food allergy trial.
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