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 in 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 alleviate symptoms of CSU in patients who are unresponsive to standard antihistamine treatments.
This study is interventional, with participants randomly assigned to different treatment groups. It follows a parallel intervention model with quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are all blinded. The primary purpose of the study is treatment.
The study began on July 19, 2024, with primary completion expected by July 2025. The last update was submitted on July 29, 2025. These dates are crucial for tracking the study’s progress and potential market entry.
The outcome of this study could significantly impact Celldex Therapeutics’ stock performance. Positive results may boost investor confidence and position Celldex competitively within the pharmaceutical industry, especially against other companies developing treatments for CSU.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.