Barzolvolimab Shows Promise for Cold Urticaria and Dermographism

The investigational monoclonal antibody barzolvolimab significantly improved provocation test outcomes and reduced symptoms compared with placebo in patients with cold urticaria and symptomatic dermographism, according to results from a phase II trial presented at the recent American College of Allergy, Asthma & Immunology annual meeting.

In this exclusive MedPage Today video, investigator Jonathan Bernstein, MD, of the University of Cincinnati Medical Center, discusses the study results.

Following is a transcript of his remarks:

The study was broken into two groups of patients: patients who had a history of cold-induced urticaria, and this is diagnosed by either something called a TempTest, where you can show a wheel and flare in response to cold temperatures and it grades, it tells you actually what the lowest temperature that elicits a wheel and flare; and then also symptomatic dermographism, and this can be diagnosed by something called the FricTest, which has multiple prongs, and you scratch the forearm and you can see the skin welt up within 2 minutes. And so these are two tests that have been used to diagnose and quantify response to treatment.

And for each arm there were 96 patients in the cold-induced urticaria patient population, there were 97 patients in the symptomatic dermatographia population. There were three arms. There was a placebo arm. Every 4 weeks there was barzolvolimab, which is 150 mg every 4 weeks. And barzolvolimab 300 mg every 8 weeks. And this was the same design for both the cold-induced urticaria and the symptomatic dermographism.

So they had to have these conditions for 3 months to qualify. They had to have evidence of wheels that were present despite the use of antihistamines. And then they had to also have a positive provocation test. And at randomization, they had to show poor control in response to these triggers.

And so the primary endpoint was to look at the percentage of patients with negative provocation test at week 12, either using the cold TempTest or for the symptomatic dermographism, the FricTest. They had several other secondary endpoints. And then, of course, an exploratory endpoint was the urticaria control test.

And the bottom line was that when we looked at the randomization of these groups — there was good randomization at baseline, so the patients were equally distributed between groups — and what they found was at the end of the 12 weeks for cold-induced urticaria and for symptomatic dermographism, that barzolvolimab was effective at increasing the number of patients who had a negative provocation test, either using the TempTest for cold-induced, or the FricTest for symptomatic dermatographia.

So it was also very effective at reducing itch at the time of provocation compared to placebo for both groups. And the urticaria control test also improved in both groups, which is a validated test to look at control of hives.

It was generally well tolerated. The safety profile was very consistent with previous studies. So there are phase III trials planned for CIndU [chronic inducible urticaria].