Celldex Therapeutics (CLDX) announced an update on their ongoing clinical study.
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Study Overview: Celldex Therapeutics is conducting a Phase 3b study titled ‘A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13.’ The study aims to gather long-term efficacy and safety data on barzolvolimab for adults with Chronic Spontaneous Urticaria (CSU) who completed prior Phase 3 trials. This extension study is significant as it provides post-trial access to the treatment, fulfilling Celldex’s commitment to its participants.
Intervention/Treatment: The study is testing barzolvolimab, a biological treatment administered subcutaneously. It is intended to manage CSU symptoms more effectively than standard care, which includes second-generation Type 1 antihistamines.
Study Design: This interventional study is non-randomized and follows a parallel intervention model. It is designed with no masking, and its primary purpose is treatment. Participants are divided into two groups: one receiving standard care with potential barzolvolimab intervention if symptoms worsen, and another receiving regular barzolvolimab treatment.
Study Timeline: The study began on November 20, 2025, with the latest update submitted on December 2, 2025. These dates are crucial as they mark the study’s initiation and recent progress, indicating ongoing recruitment and data collection.
Market Implications: The update on this study could positively influence Celldex’s stock performance by demonstrating commitment to long-term treatment efficacy and safety. Investors may view this as a strategic move to strengthen Celldex’s position in the competitive CSU treatment market, potentially impacting investor sentiment favorably.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.
To learn more about CLDX’s potential, visit the Celldex Therapeutics drug pipeline page.