A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

Study Purpose

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key Inclusion Criteria. 1. ≥ 18 years of age. 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.Key Exclusion Criteria. 1. Diagnosed with hypereosinophilic syndrome or Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis) 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05774184
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Celldex Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Australia, Canada, Germany, Italy, Poland, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Additional Details

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.

Arms & Interventions

Arms

Active Comparator: Barzolvolimab (CDX-0159)

300 mg subcutaneous administration every 4 weeks through week 24

Placebo Comparator: 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

Interventions

Biological: - barzolvolimab

subcutaneous administration

Drug: - Matching Placebo

subcutaneous administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

AllerVie Clinical Research, Birmingham, Alabama

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AllerVie Clinical Research

Birmingham, Alabama, 35209

One of a Kind Clinical Research Center, Scottsdale, Arizona

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One of a Kind Clinical Research Center

Scottsdale, Arizona, 85258

Sun City, Arizona

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GI Alliance- Arizona Digestive Health- Sun City

Sun City, Arizona, 85351

Del Sol Research Management, LLC, Tucson, Arizona

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Del Sol Research Management, LLC

Tucson, Arizona, 85715

GW Research Inc., Chula Vista, California

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GW Research Inc.

Chula Vista, California, 91910

Bristol, Connecticut

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Connecticut Clinical Research Institute, LLC

Bristol, Connecticut, 06416

Jacksonville, Florida

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University of Florida (UF) - Jacksonville

Jacksonville, Florida, 32209

ENCORE Borland Groover Clinical Research, Jacksonville, Florida

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ENCORE Borland Groover Clinical Research

Jacksonville, Florida, 32256

Gastroenterology of Greater Orlando, Orange City, Florida

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Gastroenterology of Greater Orlando

Orange City, Florida, 32763

Treasure Valley Medical Research, Boise, Idaho

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Treasure Valley Medical Research

Boise, Idaho, 83706

Northwestern University, Chicago, Illinois

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Northwestern University

Chicago, Illinois, 60208

University of Iowa, Iowa City, Iowa

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University of Iowa

Iowa City, Iowa, 52242

Kansas City, Kansas

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University of Kansas Medical Center (KUMC)

Kansas City, Kansas, 66160

Tandem Clinical Research, Marrero, Louisiana

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Tandem Clinical Research

Marrero, Louisiana, 70072

Boston, Massachusetts

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Boston Specialists - Boston Food Allergy Center

Boston, Massachusetts, 02111

NYU Langone Health, New York, New York

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NYU Langone Health

New York, New York, 10016

Chapel Hill, North Carolina

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University of North Carolina (UNC) Hospitals

Chapel Hill, North Carolina, 27514

Duke University Medical Center, Durham, North Carolina

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Duke University Medical Center

Durham, North Carolina, 27710

Cincinnati, Ohio

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

The Clinical Trials Network, LLC, Willoughby, Ohio

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The Clinical Trials Network, LLC

Willoughby, Ohio, 44096

Hershey, Pennsylvania

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The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

University of Pennsylvania, Philadelphia, Pennsylvania

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University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Nashville, Tennessee

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Vanderbilt University Medical Center-GI Clinical Research Program

Nashville, Tennessee, 37232

Advanced Research Institute - Ogden, Ogden, Utah

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Advanced Research Institute - Ogden

Ogden, Utah, 84405

Care Access Research, Salt Lake City, Utah

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Care Access Research

Salt Lake City, Utah, 84124

University of Utah, Salt Lake City, Utah

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University of Utah

Salt Lake City, Utah, 84132

International Sites

Royal Adelaide Hospital, Adelaide, South Australia, Australia

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Royal Adelaide Hospital

Adelaide, South Australia,

The Alfred Hospital, Melbourne, Victoria, Australia

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The Alfred Hospital

Melbourne, Victoria,

St Vincent's Hospital Melbourne, Melbourne, Australia

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St Vincent's Hospital Melbourne

Melbourne, ,

University of Calgary, Calgary, Alberta, Canada

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University of Calgary

Calgary, Alberta,

PerCuro Clinical Research Ltd., Victoria, British Columbia, Canada

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PerCuro Clinical Research Ltd.

Victoria, British Columbia,

Universitaetsklinikum Augsburg, Augsburg, Germany

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Universitaetsklinikum Augsburg

Augsburg, ,

Klinikum Region Hannover GmbH Burgwedel, Hannover, Germany

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Klinikum Region Hannover GmbH Burgwedel

Hannover, ,

Universitaetsklinikum Leipzig, Leipzig, Germany

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Universitaetsklinikum Leipzig

Leipzig, ,

Universitaetsklinikum Magdeburg A.oe.R., Magdeburg, Germany

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Universitaetsklinikum Magdeburg A.oe.R.

Magdeburg, ,

IRCCS Ospedale San Raffaele, Milano, Italy

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IRCCS Ospedale San Raffaele

Milano, ,

Azienda Ospedale - Università Padova, Padova, Italy

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Azienda Ospedale - Università Padova

Padova, ,

Rome, Italy

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Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Rome, ,

Istituto Clinico Humanitas, Rozzano, Italy

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Istituto Clinico Humanitas

Rozzano, ,

Salerno, Italy

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Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona-Plesso "Ruggi"

Salerno, ,

Verona, Italy

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Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

Verona, ,

Centrum Zdrowia MDM - EB Group Sp. z o.o, Warszawa, Poland

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Centrum Zdrowia MDM - EB Group Sp. z o.o

Warszawa, ,

WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland

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WIP Warsaw IBD Point Profesor Kierkus

Warszawa, ,

Warszawa, Poland

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Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob

Warszawa, ,

Centrum Medyczne Med-Gastr Sp. z o.o., Łódź, Poland

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Centrum Medyczne Med-Gastr Sp. z o.o.

Łódź, ,

Alicante, Spain

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Hospital General Universitario de Alicante Dr. Balmis

Alicante, ,

Hospital Clinico San Carlos, Madrid, Spain

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Hospital Clinico San Carlos

Madrid, ,

Hospital Universitario de La Princesa, Madrid, Spain

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Hospital Universitario de La Princesa

Madrid, ,

Sabadell, Spain

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Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

Sabadell, ,

Hospital Universitario Miguel Servet, Zaragoza, Spain

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Hospital Universitario Miguel Servet

Zaragoza, ,

St George's Hospital, London, United Kingdom

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St George's Hospital

London, ,

St. Thomas' Hospital, London, United Kingdom

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St. Thomas' Hospital

London, ,

Norfolk and Norwich University Hospital, Norwich, United Kingdom

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Norfolk and Norwich University Hospital

Norwich, ,

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