Celldex Therapeutics (CLDX) announced an update on their ongoing clinical study.
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Study Overview
The EvolvE study, officially titled “A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults With Active Eosinophilic Esophagitis (The EvolvE Study),” evaluates Celldex Therapeutics’ lead drug in patients with eosinophilic esophagitis, a chronic inflammatory disease of the esophagus. The main goal is to see whether barzolvolimab can reduce disease activity and improve symptoms while maintaining an acceptable safety profile, a key step toward potential late-stage development and future commercialization.
Intervention/Treatment
The study tests barzolvolimab (CDX-0159), a biological medicine given by injection under the skin. One group receives 300 mg every four weeks for 24 weeks, while another group receives a matching placebo every four weeks through week 16 and then switches to barzolvolimab through week 24. The intent is to block disease-driving pathways and offer a targeted treatment option for patients who have few effective choices today.
Study Design
This is an interventional Phase 2 trial with patients randomly assigned to barzolvolimab or placebo. It uses a parallel group design, meaning each patient stays in their assigned group during the blinded phase. The study is “quadruple-blind,” so patients, caregivers, investigators, and outcome assessors do not know who receives active drug or placebo during that phase. The primary purpose is treatment, focused on how well the drug works and how safe it is versus placebo.
Study Timeline
The study was first submitted to the registry on March 7, 2023, marking the formal start of regulatory tracking and investor visibility. The trial is listed as Phase 2 and has now been updated with an overall status of “Completed,” indicating that treatment and follow-up are finished. While primary and final completion dates are not explicitly shown here, the most recent update was filed on January 29, 2026, signaling that Celldex has locked in key study information and is preparing, or may soon prepare, data disclosures.
Market Implications
The completion and recent update of the EvolvE study are important catalysts for Celldex (CLDX). With a Phase 2 trial in eosinophilic esophagitis now completed, investors will focus on the strength of upcoming data, including symptom relief, tissue healing, and safety. Positive results could support moving barzolvolimab into larger Phase 3 trials, strengthening Celldex’s pipeline value and possibly driving a rerating of the stock. Because eosinophilic esophagitis is an emerging market with few approved therapies and strong interest from larger players, a clear efficacy signal could draw partnership interest or position Celldex as a potential acquisition target. Conversely, weak or mixed outcomes may pressure the share price, as barzolvolimab is a central asset for the company. In the broader sector, competitors working on eosinophilic and allergic diseases will be watched in parallel, but the main trading driver in the near term will be how the EvolvE readout matches or exceeds investor expectations.
The EvolvE study of barzolvolimab in eosinophilic esophagitis is now completed and recently updated, with further details available on the ClinicalTrials.gov portal.
To learn more about CLDX’s potential, visit the Celldex Therapeutics drug pipeline page.
