Core Insights - Celldex has initiated a global Phase 3 trial (EMBARQ-ColdU and SD) to evaluate the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who are symptomatic despite H1 antihistamine treatment [1][2] - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, crucial for mast cell function, which is a key driver in ColdU and SD [1][7] - The trial aims to enroll approximately 240 participants across 75 clinical sites in 7 countries, with a primary endpoint focused on the percentage of patients achieving a complete response at Week 12 [2][3] Study Design and Objectives - The EMBARQ-ColdU and SD trial will include two cohorts: one for ColdU and one for SD, with participants randomized in a 1:1 ratio to receive either barzolvolimab or placebo for 24 weeks [2][3] - The primary endpoint will assess the complete response rate using TempTest® for ColdU and FricTest® for SD at Week 12, with follow-up for 16 weeks post-treatment [2][5] Clinical Background and Need - ColdU and SD affect over 533,000 patients in the U.S. and Europe, with no advanced therapies currently approved, leading to inadequate disease control for over 80% of patients [3][4] - Patients often experience severe itching and hives, significantly impacting their mental and emotional well-being, daily activities, and social interactions [3][4] Previous Study Results - A Phase 2 study showed that barzolvolimab met its primary endpoint, demonstrating a statistically significant difference in negative provocation tests compared to placebo at Week 12, with up to 75% of ColdU patients and 67% of SD patients achieving a partial or complete response [3][5] - Secondary endpoints also showed strong support for the primary results, with sustained effects through the end of the treatment period [5] Future Directions - Barzolvolimab is being studied across five indications, including chronic spontaneous urticaria, with ongoing Phase 3 studies and plans for additional indications [3][7] - The initiation of the EMBARQ-ColdU and SD trial represents a significant advancement in treatment options for patients suffering from these conditions [4][5]