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-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 current antihistamine treatments.
Intervention/Treatment: The study tests barzolvolimab, a biological treatment administered subcutaneously. It is designed to improve symptoms in CSU patients who have not found relief with standard antihistamine therapy.
Study Design: This is a randomized, double-blind, placebo-controlled study with a parallel intervention model. Participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocations. The primary purpose is to assess treatment efficacy.
Study Timeline: The study began on June 7, 2024, with the primary completion and estimated study completion dates yet to be announced. The latest update was submitted on August 28, 2025, indicating ongoing recruitment and progress.
Market Implications: The progress of this study could significantly impact Celldex Therapeutics’ stock performance, as positive results may enhance investor confidence and market position. The study’s outcome could also influence the competitive landscape in the treatment of CSU, where effective new therapies are in demand.
The study is ongoing, with further details available on the ClinicalTrials portal.