Celldex Therapeutics ((CLDX)) announced an update on their ongoing clinical study.
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Celldex Therapeutics is conducting a Phase 3 clinical trial 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 improve symptoms in patients with CSU, offering a potential new therapeutic option for those who have limited relief from existing medications.
This study is interventional and uses a randomized, parallel assignment model. It employs quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation. The primary purpose of the study is treatment-focused.
The study began on May 31, 2024, with primary completion expected in 2025. The latest update was submitted on August 26, 2025. These dates are crucial for tracking the study’s progress and anticipating when results might be available.
The outcome of this study could significantly impact Celldex Therapeutics’ stock performance and investor sentiment, as successful results may position barzolvolimab as a leading treatment in the CSU market. This could also affect the competitive landscape, influencing other companies in the dermatology and immunology sectors.
The study is currently ongoing, with further details available on the ClinicalTrials portal.