A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Drug: Matching Placebo
- Registration Number
- NCT05774184
- Lead Sponsor
- Celldex Therapeutics
- Brief Summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
- Detailed Description
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 86
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo then barzolvolimab (CDX-0159) 300mg Matching Placebo Matching placebo subcutaneous administration every 4 weeks through week 16, then 300mg subcutaneous administration every 4 weeks through week 24 Barzolvolimab (CDX-0159) barzolvolimab 300 mg subcutaneous administration every 4 weeks through week 24
- Primary Outcome Measures
Name Time Method Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf). From baseline to Visit 6 (Week 12) 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.
- Secondary Outcome Measures
Name Time Method Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ). From baseline to Visit 6 (Week 12) DSQ is a questionnaire designed to measure difficulty swallowing associated with Eosinophilic Esophagitis (EoE), with total scores ranging from 0 to 84; higher DSQ scores indicate worse symptoms.
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC ≥ 12/hpf. From baseline to Visit 6 (Week 12) 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.
Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf). From baseline to Visit 6 (Week 12) Peak esophageal intraepithelial eosinophils will be determined by counting eosinophils in the most inflamed high-power field (hpf) of each of the 3 esophageal (proximal, mid, distal) levels and reported as eosinophils/hpf.
Percent (%) change from baseline to Week 12 in PMC/hpf. From baseline to Visit 6 (Week 12) 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.
Incidence of Treatment Emergent Adverse Events. From first dose through Visit 14 (Week 44) The rates of treatment emergent adverse events will be summarized.
Related Research Topics
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Trial Locations
- Locations (45)
The Clinical Trials Network, LLC
🇺🇸Willoughby, Ohio, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center-GI Clinical Research Program
🇺🇸Nashville, Tennessee, United States
Advanced Research Institute - Ogden
🇺🇸Ogden, Utah, United States
Care Access Research
🇺🇸Salt Lake City, Utah, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
St Vincent's Hospital Melbourne
🇦🇺Melbourne, Australia
Scroll for more (35 remaining)The Clinical Trials Network, LLC🇺🇸Willoughby, Ohio, United States