Celldex Therapeutics ((CLDX)) announced an update on their ongoing clinical study.
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Celldex Therapeutics is conducting a Phase 3 study titled A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1). The study aims to evaluate the efficacy, safety, and tolerability of barzolvolimab in adults with Chronic Spontaneous Urticaria (CSU) who do not respond adequately to standard H1-antihistamine treatments.
The intervention being tested is barzolvolimab, a biological treatment administered subcutaneously. It is designed to alleviate symptoms in patients with CSU who are not sufficiently managed by existing antihistamine therapies.
This study is interventional, with participants randomly assigned to different treatment groups. It employs a parallel intervention model and uses quadruple masking to ensure unbiased results. The primary purpose of the study is treatment-focused.
The study began on July 11, 2024, and is currently recruiting participants. The last update was on August 11, 2025. These dates are crucial as they indicate the study’s progress and timelines for potential results.
This update could influence Celldex Therapeutics’ stock performance positively if the results show significant efficacy and safety of barzolvolimab. It may also affect investor sentiment, especially if the treatment proves to be a viable alternative in the competitive landscape of CSU therapies.
The study is ongoing, with further details available on the ClinicalTrials portal.