A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
NCT ID: NCT05774184
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
86 participants
INTERVENTIONAL
2023-06-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Barzolvolimab (CDX-0159)
300 mg subcutaneous administration every 4 weeks through week 24
barzolvolimab
subcutaneous administration
Placebo then barzolvolimab (CDX-0159) 300mg
Matching placebo subcutaneous administration every 4 weeks through week 16, then 300mg subcutaneous administration every 4 weeks through week 24
Matching Placebo
subcutaneous administration
Interventions
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barzolvolimab
subcutaneous administration
Matching Placebo
subcutaneous administration
Eligibility Criteria
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Inclusion Criteria
2. Documented diagnosis of eosinophilic esophagitis (EoE) by endoscopy
3. Peak esophageal intraepithelial eosinophil count (PEC) of ≥ 15 per high power field (hpf) from at least 2 of 3 levels (proximal, mid, and distal) of the esophagus
4. Symptomatic, defined as • Average of ≥ 2 days per week with dysphagia with solid food intake in the 1 month prior to Screening, and • ≥ 4 days with dysphagia within the last 2 weeks prior to randomization
5. On a stable diet which includes solid foods for ≥ 2 months prior to Screening (and throughout the study)
6. Inadequate response to or is inappropriate for and/or intolerant to a standard-of-care treatment for EoE (e.g., PPI, swallowed topical corticosteroids, or dietary elimination)
7. Willing to be compliant with completion of daily questionnaire
Exclusion Criteria
2. History of clinicopathologic diagnosis of eosinophilic gastritis or eosinophilic duodenitis
3. Known active Helicobacter pylori infection
4. History of coagulation disorders, esophageal varices, achalasia, Crohn's disease, ulcerative colitis, or celiac disease
5. Esophageal dilation within 3 months prior to Screening
6. Prior esophageal or gastric surgery that would confound the assessments of EoE
7. Esophageal stricture that is difficult to pass with a standard adult upper endoscope (9 to 10 mm) or stricture that requires dilation at the Screening EGD
8. Avoiding solid foods or using a feeding tube
9. Regular use of antiplatelet and/or anticoagulant therapy
10. Non-biologic systemic agents within 2 months prior to Screening, including but not limited to corticosteroid (oral, swallowed topical or parenteral), non-steroidal immunosuppressants (e.g., methotrexate, cyclosporin, tacrolimus, mycophenolate mofetil, azathioprine), other immunomodulators (e.g., Jak inhibitors, tyrosine kinase inhibitors), and investigational agents
11. Biologic therapy within 5 half-lives (or detectable serum level) prior to Screening, including but not limited to interleukin (IL)-4 receptor inhibitor (dupilumab), IL-5 inhibitors (e.g., mepolizumab, benralizumab), IL-13 inhibitors (e.g., tralokinumab, lebrikizumab), anti-IgE (e.g., omalizumab), IFN-γ inhibitors, or other approved or investigational biologics
12. Oral immunotherapy (OIT) within 6 months prior to Screening
13. Sublingual immunotherapy (SLIT) and/or subcutaneous immunotherapy (SCIT) Note: Not exclusionary if patient has been on a stable maintenance dose for at least 6 months prior to Screening
14. Receipt of a live vaccine within 2 months prior to the Baseline (Day 1) Visit (patients must agree to avoid live vaccination during study treatment and within 3 months thereafter).
15. Diagnosis of idiopathic anaphylaxis or other severe allergic reactions that in the opinion of the investigator, could increase the patient's risk for systemic hypersensitivity reactions
16. Prior receipt of barzolvolimab
There may be additional criteria your study doctor will review with you to confirm eligibility
18 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
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
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
Hanover, , Germany
Universitaetsklinikum Magdeburg A.oe.R.
Magdeburg, , Germany
IRCCS Ospedale San Raffaele
Milan, , 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 Medyczne Med-Gastr Sp. z o.o.
Lodz, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob
Warsaw, , Poland
Hospital General Universitario de Alicante Dr. Balmis
Alicante, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
St George's Hospital
London, , United Kingdom
St. Thomas' Hospital
London, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Countries
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Other Identifiers
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2022-001786-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-512767-30-00
Identifier Type: CTIS
Identifier Source: secondary_id
CDX0159-08
Identifier Type: -
Identifier Source: org_study_id