お知らせ • Mar 28
Celldex Therapeutics, Inc. Presents Positive Data From Phase 2 Chronic Spontaneous Urticaria And Phase 2 Cold Urticaria And Symptomatic Dermographism Studies Demonstrating Rapid, Profound And Durable Improvements In Patient Quality Of Life At AAD 2026
Celldex Therapeutics, Inc. presented additional positive data from the completed Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD) demonstrating profound improvements in patient quality of life (QoL) across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Barzolvolimab is a humanized monoclonal antibody with a completely novel mechanism of action that uniquely targets the root cause of CSU, ColdU and SD—the mast cell. The data were presented at the 2026 Americal Academy of Dermatology (AAD) Annual Meeting being held March 27 – 31, 2026 in Denver, CO. Posters are available on the Celldex website. The Dermatology Life Quality Index (DLQI) measures impact of skin disease on quality of life, with a score of 0/1 indicating no effect of the disease on a patient’s life. As previously reported in the Phase 2 CSU study, up to 51% of patients on study experienced symptom free complete response (UAS7=0; no itch/no hives) at 12 weeks, which continued to deepen over 52 weeks of active therapy to up to 71% of patients. This profound clinical benefit continued even after patients were off therapy—up to 41% of patients reported complete response seven months after receiving their last dose of barzolvolimab. In the post hoc analysis presented at AAD, the impact of disease on QoL for the subset of patients who received 52 weeks of barzolvolimab therapy (150 mg every four weeks or 300 mg every eight weeks) and completed treatment with at least well controlled disease (UAS7<6) at Week 52 and had DLQI data through Week 76 was explored. The vast majority of patients included in this analysis had substantial disease burden at baseline (68% had both severe disease and angioedema) and patients had CSU for a long time (6 years, mean). Patients reported that their CSU had a very large negative impact on their QoL (DLQI mean baseline score of 15.6). At Week 52, 94% of patients with well controlled disease at Week 52 also had a DLQI of 0/1, indicating their disease had no impact on their QoL. Barzolvolimab treatment led to prolonged, off-treatment enhanced QoL seven months after the last dose of barzolvolimab. At baseline, patients reported their CSU significantly impacted their QoL across all 6 DLQI domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Profound improvements were observed across all 6 domains at both Weeks 52 and 76. 76% of patients with well controlled disease at Week 52 also reported that the disease had small to no impact (DLQI score = 5) on their QoL at Week 76. The majority of patients with well controlled disease at Week 52 achieved DLQI domain scores of 0/1 (no impact on QoL) at Week 76. This sustained off-treatment improvement in QoL was observed despite barzolvolimab clearance and normalization of tryptase (a measure of mast cell burden), suggesting disease modification and supports barzolvolimab’s significant potential to become a transformative treatment option for patients suffering from CSU. As previously reported in the Phase 2 ColdU and SD study, up to 53% of patients with ColdU and 58% with SD achieved complete response (negative provocation test) at Week 12 (primary endpoint analysis) and up to 66% of patients with ColdU and 49% with SD achieved complete response at Week 20. Barzolvolimab treatment improved the QoL of patients with ColdU and SD throughout the 20-week treatment period. Mean DLQI improved from a very large effect of disease on QoL at baseline to a small effect of disease on QoL at Week 20. Benefits on QoL were rapid and apparent by the first DLQI measurement at Week 4 (300 mg every eight weeks). Barzolvolimab treatment increased the rate of achieving no impact of disease on QoL (DLQI of 0/1) at Week 20 by up to 3.1-fold in patients with ColdU and 4.0-fold in patients with SD vs placebo. Barzolvolimab treatment resulted in improvements across all six DLQI domains, indicating broad, beneficial effects on QoL. This Phase 2 study is the first large randomized, placebo-controlled study to demonstrate clinical benefit in patients with chronic inducible urticaria. CSU is an underdiagnosed disease of misery marked by spontaneous hives, unbearable itch, and unpredictable episodes of disfiguring swelling (angioedema) that causes substantial mental health burden, profound impact on quality of life and is associated with a 1.7-fold increase in all cause mortality at 5 years. Mast cell activation plays a central role in the onset and progression of CSU. While the goal of CSU treatment is the complete absence of symptoms, the vast majority of patients today, even those receiving the most advanced approved and available therapies, continue to suffer from itch, hives, swelling, sleep disruption, and unrelenting anxiety about when the next flare up will occur. In February, Celldex announced the completion of enrollment in the Company’s global Phase 3 program in CSU. The Program, which fully accrued six months ahead of guidance, consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. Topline data from the studies are expected in the fourth quarter of 2026. Chronic inducible urticaria (CIndU) is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them. ColdU symptoms include itching, burning wheals/hives and angioedema when skin is exposed to cold temperatures. SD symptoms include the development of wheals in response to stroking, scratching or rubbing of the skin.
