Celldex Therapeutics ((CLDX)) announced an update on their ongoing clinical study.
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Study Overview: 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.
Intervention/Treatment: The study tests barzolvolimab, a biological treatment administered subcutaneously. It is designed to help patients with CSU who are not adequately managed by existing antihistamine therapies.
Study Design: This is an interventional, randomized, parallel-group study with quadruple masking (participant, care provider, investigator, outcomes assessor). The primary purpose is treatment, and it involves a placebo-controlled phase followed by an active treatment phase.
Study Timeline: The study began on July 11, 2024, with an initial submission date of May 31, 2024. The latest update was submitted on August 11, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates.
Market Implications: The progress of this study could significantly impact Celldex Therapeutics’ stock performance and investor sentiment, especially if barzolvolimab proves effective. Success in this area could position Celldex favorably against competitors in the treatment of CSU, potentially leading to increased market share and investor interest.
The study is ongoing, with further details available on the ClinicalTrials portal.