An oral pill helped more people with trigger-induced hives than a dummy pill at week 12

IN SOME PEOPLE, everyday triggers such as light scratching, cold, or a rise in body heat cause itchy hives or swelling that keep coming back. That long-lasting condition is chronic inducible urticaria. Three common types are hives after light scratching or rubbing, known as symptomatic dermographism, hives after cold, known as cold urticaria, and small hives after the body heats up, including from exercise or a hot bath, known as cholinergic urticaria.

The itching and swelling are driven by histamine and other chemicals released from immune cells called mast cells. An oral pill can block Bruton's tyrosine kinase, a signaling protein inside those cells that helps them release histamine. Medicines that work this way are BTK inhibitors. The pill tested here is remibrutinib, sold under the brand name Rhapsido.

Novartis tested that pill in RemIND, a Phase 3 trial in 362 adults whose symptoms were not controlled by standard antihistamine pills. The study had six groups, two for each of the three types. Within each type, people were assigned by chance, a step called randomization, in a one-to-one ratio, to remibrutinib 25 mg twice daily or to a dummy pill, or placebo. For the first 24 weeks, the participants, the investigators, and the people scoring the tests were not told the assignment. From week 24 to week 52, everyone received remibrutinib and the assignment was no longer concealed, an open-label switch, so there was no remaining dummy-pill group.

The main question the trial was built to answer, its primary endpoint, was the share of people with a complete response at week 12 on a trigger test for each type. A complete response meant no hives after a standard scratch test for dermographism, no hives at any setting of 4°C or warmer on a cold test device for cold urticaria, and no itch after a controlled exercise test for cholinergic urticaria. In the dermographism group, 17 of 58 people on remibrutinib (29.3%) had a complete response, against 8 of 57 (14.0%) on placebo, figures from the Food and Drug Administration's official label. In cold urticaria the rates were 56.3% versus 14.6%, among 48 people in each arm. In cholinergic urticaria they were 29.3% versus 15.8%, among 75 people on the drug and 76 on placebo.

On November 12th, 2026, at a meeting of the American College of Allergy, Asthma and Immunology in Phoenix, investigators including Giselle Mosnaim, an allergist and immunologist at Endeavor Health and the lead RemIND investigator, reported results through week 52. Novartis described the findings as showing "sustained" efficacy. The later figures are complete-or-partial response rates, not complete response alone, from observed data in people who still had a measurable test. The slides give no evaluable number at week 52, so rates appear beside the number randomized. Among people first assigned to remibrutinib, the combined rates were 46.8% in dermographism (58 randomized), 83.3% in cold urticaria (48), and 58.2% in cholinergic urticaria (75). Among people who switched from placebo at week 24, they were 47.7% (57 randomized), 88.9% (48), and 69.8% (76).

Because everyone could take the drug after week 24, those later rates can speak to how responses lasted, but they cannot re-prove the drug against a dummy pill, and they are not a new test of the week-12 primary question. The FDA label says, of the dermographism group, that although RemIND included an open-label period, "efficacy is based on results from 115 patients treated during the placebo-controlled period of 24 weeks."

The late-breaking slides say that in the 24-week dummy-pill period, 117 of 181 people on remibrutinib (64.6%) and 114 of 181 on placebo (63.0%) had any adverse event, with serious events in none versus 5 of 181 (2.8%), and with 8 of 181 (4.4%) and 5 of 181 (2.8%) stopping because of an adverse event, and no deaths reported. Novartis and the authors describe that safety profile as "favorable."

On October 7, 2026, the FDA approved remibrutinib for symptomatic dermographism in adults whose symptoms are not controlled by antihistamines, on the basis of the dermographism group in RemIND. The pill was already approved for chronic spontaneous urticaria, hives that appear without a known trigger, and cold urticaria and cholinergic urticaria are not approved uses. Novartis says it plans additional regulatory submissions for chronic inducible urticaria based on these results. An optional extension is still running, with the trial registry estimating completion on June 15, 2029.