A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Drug: Matching PlaceboBiological: barzolvolimab
- 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
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
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 โฅ 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)
Northwestern University
๐บ๐ธChicago, Illinois, United States
Cincinnati Children's Hospital Medical Center
๐บ๐ธCincinnati, Ohio, United States
Duke University Medical Center
๐บ๐ธDurham, North Carolina, United States
Care Access Research
๐บ๐ธSalt Lake City, Utah, United States
University of Utah
๐บ๐ธSalt Lake City, Utah, United States
AllerVie Clinical Research
๐บ๐ธBirmingham, Alabama, United States
Azienda Ospedale - Universitร Padova
๐ฎ๐นPadova, Italy
Istituto Clinico Humanitas
๐ฎ๐นRozzano, Italy
St Vincent's Hospital Melbourne
๐ฆ๐บMelbourne, Australia
Universitaetsklinikum Augsburg
๐ฉ๐ชAugsburg, Germany
PerCuro Clinical Research Ltd.
๐จ๐ฆVictoria, British Columbia, Canada
University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
IRCCS Ospedale San Raffaele
๐ฎ๐นMilano, Italy
WIP Warsaw IBD Point Profesor Kierkus
๐ต๐ฑWarszawa, Poland
Centrum Medyczne Med-Gastr Sp. z o.o.
๐ต๐ฑลรณdลบ, Poland
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
๐ฎ๐นVerona, Italy
Royal Adelaide Hospital
๐ฆ๐บAdelaide, South Australia, Australia
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
๐ฎ๐นRome, Italy
St George's Hospital
๐ฌ๐งLondon, United Kingdom
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
๐ช๐ธSabadell, Spain
Hospital Clinico San Carlos
๐ช๐ธMadrid, Spain
Hospital Universitario de La Princesa
๐ช๐ธMadrid, Spain
Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona-Plesso "Ruggi"
๐ฎ๐นSalerno, Italy
Norfolk and Norwich University Hospital
๐ฌ๐งNorwich, United Kingdom
St. Thomas' Hospital
๐ฌ๐งLondon, United Kingdom
Universitaetsklinikum Magdeburg A.oe.R.
๐ฉ๐ชMagdeburg, Germany
Klinikum Region Hannover GmbH Burgwedel
๐ฉ๐ชHannover, Germany
Universitaetsklinikum Leipzig
๐ฉ๐ชLeipzig, Germany
Hospital General Universitario de Alicante Dr. Balmis
๐ช๐ธAlicante, Spain
Hospital Universitario Miguel Servet
๐ช๐ธZaragoza, Spain
Advanced Research Institute - Ogden
๐บ๐ธOgden, Utah, United States
GI Alliance- Arizona Digestive Health- Sun City
๐บ๐ธSun City, Arizona, United States
Del Sol Research Management, LLC
๐บ๐ธTucson, Arizona, United States
GW Research Inc.
๐บ๐ธChula Vista, California, United States
ENCORE Borland Groover Clinical Research
๐บ๐ธJacksonville, Florida, United States
University of Florida (UF) - Jacksonville
๐บ๐ธJacksonville, Florida, United States
Gastroenterology of Greater Orlando
๐บ๐ธOrange City, Florida, United States
University of Iowa
๐บ๐ธIowa City, Iowa, United States
Tandem Clinical Research
๐บ๐ธMarrero, Louisiana, United States
Boston Specialists - Boston Food Allergy Center
๐บ๐ธBoston, Massachusetts, United States
University of Kansas Medical Center (KUMC)
๐บ๐ธKansas City, Kansas, United States
NYU Langone Health
๐บ๐ธNew York, New York, United States
University of North Carolina (UNC) Hospitals
๐บ๐ธChapel Hill, North Carolina, United States
The Clinical Trials Network, LLC
๐บ๐ธWilloughby, Ohio, United States
Treasure Valley Medical Research
๐บ๐ธBoise, Idaho, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
๐บ๐ธHershey, Pennsylvania, United States
Vanderbilt University Medical Center-GI Clinical Research Program
๐บ๐ธNashville, Tennessee, United States
One of a Kind Clinical Research Center
๐บ๐ธScottsdale, Arizona, United States
Centrum Zdrowia MDM - EB Group Sp. z o.o
๐ต๐ฑWarszawa, Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob
๐ต๐ฑWarszawa, Poland
Connecticut Clinical Research Institute, LLC
๐บ๐ธBristol, Connecticut, United States
University of Calgary
๐จ๐ฆCalgary, Alberta, Canada
The Alfred Hospital
๐ฆ๐บMelbourne, Victoria, Australia