Clinical Trial: A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: 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)
Brief Summary: The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Detailed Summary: The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Sponsor: Celldex Therapeutics
Current Primary Outcome: Peak esophageal intraepithelial mast cell counts will be determined by counting mast cells in the most inflamed high-power field (hpf) of each of the 3 esophageal (proximal, mid, distal) levels and reported as mast cells/hpf.
Original Primary Outcome: Peak esophageal intraepithelial mast cell counts will be determined by counting mast cells in the most inflamed high-power field (hpf) of each of the 3 esophageal (proximal, mid, distal) levels and reported as mast cells/hpf.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Celldex Therapeutics
Dates:
Date Received: March 07, 2023
Date Started: June 01, 2023
Date Completion: June 01, 2023
Last Updated: December 01, 2023
Last Verified: December 01, 2023