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-CSU2)’. The study aims to evaluate the efficacy, safety, and tolerability of barzolvolimab for adults with Chronic Spontaneous Urticaria (CSU) who do not respond adequately to H1-antihistamines.
The intervention being tested is barzolvolimab, a biological treatment administered subcutaneously. It is designed to help manage symptoms in patients with CSU who have not found relief with standard antihistamine treatments.
This interventional study is randomized and follows a parallel assignment model with quadruple masking. Its primary purpose is treatment, aiming to provide a new therapeutic option for CSU patients.
The study began on July 19, 2024, with an estimated primary completion date yet to be announced. The latest update was submitted on June 25, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
The outcome of this study could significantly impact Celldex Therapeutics’ stock performance, as positive results may enhance investor confidence and market position. The competitive landscape in the CSU treatment market could also shift, depending on the study’s findings.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.