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.
Trial Locations
- Locations (53)
AllerVie Clinical Research
🇺🇸Birmingham, Alabama, United States
One of a Kind Clinical Research Center
🇺🇸Scottsdale, Arizona, United States
GI Alliance- Arizona Digestive Health- Sun City
🇺🇸Sun City, Arizona, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
GW Research Inc.
🇺🇸Chula Vista, California, United States
Connecticut Clinical Research Institute, LLC
🇺🇸Bristol, Connecticut, United States
University of Florida (UF) - Jacksonville
🇺🇸Jacksonville, Florida, United States
ENCORE Borland Groover Clinical Research
🇺🇸Jacksonville, Florida, United States
Gastroenterology of Greater Orlando
🇺🇸Orange City, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center (KUMC)
🇺🇸Kansas City, Kansas, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Boston Specialists - Boston Food Allergy Center
🇺🇸Boston, Massachusetts, United States
NYU Langone Health
🇺🇸New York, New York, United States
University of North Carolina (UNC) Hospitals
🇺🇸Chapel Hill, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
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
University of Calgary
🇨🇦Calgary, Alberta, Canada
PerCuro Clinical Research Ltd.
🇨🇦Victoria, British Columbia, Canada
Universitaetsklinikum Augsburg
🇩🇪Augsburg, Germany
Klinikum Region Hannover GmbH Burgwedel
🇩🇪Hannover, Germany
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitaetsklinikum Magdeburg A.oe.R.
🇩🇪Magdeburg, Germany
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Azienda Ospedale - Università Padova
🇮🇹Padova, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona-Plesso "Ruggi"
🇮🇹Salerno, Italy
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
🇮🇹Verona, Italy
Centrum Zdrowia MDM - EB Group Sp. z o.o
🇵🇱Warszawa, Poland
WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warszawa, Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob
🇵🇱Warszawa, Poland
Centrum Medyczne Med-Gastr Sp. z o.o.
🇵🇱Łódź, Poland
Hospital General Universitario de Alicante Dr. Balmis
🇪🇸Alicante, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
🇪🇸Sabadell, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
St George's Hospital
🇬🇧London, United Kingdom
St. Thomas' Hospital
🇬🇧London, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom