Novartis AG (NYSE:AG) on Wednesday released positive topline results from its pivotal Phase 3 RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU).

The Disease

The primary endpoint was met for the three most prevalent types of CIndU, achieving significantly higher complete response rates versus placebo at Week 121. The most common types include:

Minor skin pressure, scratching, or rubbing triggers itchy, red, linear wheals in Symptomatic dermographism patients.

Cold urticaria: Exposure to cold temperatures—air, water, or objects—triggers itchy red welts (hives).

Cholinergic urticaria is triggered by a rise in body temperature and sweat, causing small, itchy red bumps or wheals.

First Targeted Therapy

These data represent an important advance ...