Share
Save
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Study details:
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-06-01
Primary completion: 2025-03-01
Study completion finish: 2025-08-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05774184
Intervention or treatment
BIOLOGICAL: barzolvolimab
DRUG: Matching Placebo
Conditions
- • Eosinophilic Esophagitis
Find a site
Closest Location:
Royal Adelaide Hospital
Research sites nearby
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital Melbourne
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Barzolvolimab (CDX-0159)
| BIOLOGICAL: barzolvolimab
|
PLACEBO_COMPARATOR: Placebo then barzolvolimab (CDX-0159) 300mg
| DRUG: Matching Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf). | 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. | From baseline to Visit 6 (Week 12) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ). | 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. | From baseline to Visit 6 (Week 12) |
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC ≥ 12/hpf. | 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. | From baseline to Visit 6 (Week 12) |
Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf). | 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. | From baseline to Visit 6 (Week 12) |
Percent (%) change from baseline to Week 12 in PMC/hpf. | 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. | From baseline to Visit 6 (Week 12) |
Incidence of Treatment Emergent Adverse Events. | The rates of treatment emergent adverse events will be summarized. | From first dose through Visit 14 (Week 44) |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!