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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 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

Status

Recruiting

Address

AllerVie Clinical Research

Birmingham, Alabama, 35209

Site Contact

Ashley Brown

Asbrown@Allervie.com

844-723-9363

One of a Kind Clinical Research Center, Scottsdale, Arizona

Status

Recruiting

Address

One of a Kind Clinical Research Center

Scottsdale, Arizona, 85258

Site Contact

Anna Fehr

anna@1-oak.net

844-723-9363

Sun City, Arizona

Status

Recruiting

Address

GI Alliance- Arizona Digestive Health- Sun City

Sun City, Arizona, 85351

Site Contact

Claire Petersen

cpetersen@arizonadigestivehealth.com

844-723-9363

Del Sol Research Management, LLC, Tucson, Arizona

Status

Recruiting

Address

Del Sol Research Management, LLC

Tucson, Arizona, 85715

Site Contact

Nayeli Lopez

nlopez@delsolresearch.com

844-723-9363

GW Research Inc., Chula Vista, California

Status

Recruiting

Address

GW Research Inc.

Chula Vista, California, 91910

Site Contact

Lindsay Osorio

crc8@gwresearch.net

844-723-9363

Bristol, Connecticut

Status

Recruiting

Address

Connecticut Clinical Research Institute, LLC

Bristol, Connecticut, 06416

Site Contact

Cecile Guttermuth

cguttermuth@connecticutgi.org

844-723-9363

Jacksonville, Florida

Status

Recruiting

Address

University of Florida (UF) - Jacksonville

Jacksonville, Florida, 32209

Site Contact

Kelly Jackman

kelly.jackman@jax.ufl.edu

844-723-9363

ENCORE Borland Groover Clinical Research, Jacksonville, Florida

Status

Recruiting

Address

ENCORE Borland Groover Clinical Research

Jacksonville, Florida, 32256

Site Contact

Jacob Wolfer

jawolfer@encoredocs.com

844-723-9363

Gastroenterology of Greater Orlando, Orange City, Florida

Status

Recruiting

Address

Gastroenterology of Greater Orlando

Orange City, Florida, 32763

Site Contact

Parteek Sharma

psharma@gastro-md.com

844-723-9363

Treasure Valley Medical Research, Boise, Idaho

Status

Recruiting

Address

Treasure Valley Medical Research

Boise, Idaho, 83706

Site Contact

Stephanie Gil

sgil@tvmedresearch.com

844-723-9363

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60208

Site Contact

Tenesha Thomas-McCain

tenesha.thomas@northwestern.edu

844-723-9363

University of Iowa, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa

Iowa City, Iowa, 52242

Site Contact

Ethan Hoover

ethan-hoover@uiowa.edu

844-723-9363

Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, 66160

Site Contact

Jill Torneden

jtorneden2@kumc.edu

844-723-9363

Tandem Clinical Research, Marrero, Louisiana

Status

Recruiting

Address

Tandem Clinical Research

Marrero, Louisiana, 70072

Site Contact

Brittany Valence

bvalence@tandemclinicalresearch.com

844-723-9363

Boston, Massachusetts

Status

Recruiting

Address

Boston Specialists - Boston Food Allergy Center

Boston, Massachusetts, 02111

Site Contact

Rachel Solecki

rachel.s@bfac.org

844-723-9363

NYU Langone Health, New York, New York

Status

Recruiting

Address

NYU Langone Health

New York, New York, 10016

Site Contact

Matthew OMara

Matthew.Omara@nyulangone.org

844-723-9363

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina (UNC) Hospitals

Chapel Hill, North Carolina, 27514

Site Contact

Gracie Whitley

gracie_whitley@med.unc.edu

844-723-9363

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Chris Efird

Chris.Efird@duke.edu

844-723-9363

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Pratibha Kemtur

pratibha.kemtur@cchmc.org

844-723-9363

The Clinical Trials Network, LLC, Willoughby, Ohio

Status

Recruiting

Address

The Clinical Trials Network, LLC

Willoughby, Ohio, 44096

Site Contact

Marisha Lewis

MarishaL@greatlakesgastro.net

844-723-9363

Hershey, Pennsylvania

Status

Recruiting

Address

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

Hershey, Pennsylvania, 17033

Site Contact

Z.Stella Chroneos

zchroneos1@pennstatehealth.psu.edu

844-723-9363

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Maureen DeMarshall

demarshm@pennmedicine.upenn.edu

844-723-9363

Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center-GI Clinical Research Program

Nashville, Tennessee, 37232

Site Contact

Larry Raber

larry.w.raber@vumc.org

844-723-9363

Advanced Research Institute - Ogden, Ogden, Utah

Status

Recruiting

Address

Advanced Research Institute - Ogden

Ogden, Utah, 84405

Site Contact

Nephi Georgi

nephi@advresearch.org

844-723-9363

Care Access Research, Salt Lake City, Utah

Status

Recruiting

Address

Care Access Research

Salt Lake City, Utah, 84124

Site Contact

Lisa Gamble

l.gamble@careaccess.com

844-723-9363

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84132

Site Contact

Amy Nichols

amy.nichols@hsc.utah.edu

844-723-9363

International Sites

St Vincent's Hospital Melbourne, Melbourne, Australia

Status

Recruiting

Address

St Vincent's Hospital Melbourne

Melbourne, ,

Site Contact

Rose Sloane

Rosemary.Sloane@svha.org.au

844-723-9363

University of Calgary, Calgary, Alberta, Canada

Status

Recruiting

Address

University of Calgary

Calgary, Alberta,

Site Contact

Karen Graham

kagraham@ucalgary.ca

844-723-9363

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

Status

Recruiting

Address

PerCuro Clinical Research Ltd.

Victoria, British Columbia,

Site Contact

Ghassan AlWafai

Ghassan@percuro.ca

844-723-9363

Universitaetsklinikum Augsburg, Augsburg, Germany

Status

Recruiting

Address

Universitaetsklinikum Augsburg

Augsburg, ,

Site Contact

Sandra Nagl

sandra.nagl@uk-augsburg.de

844-723-9363

Klinikum Region Hannover GmbH Burgwedel, Hannover, Germany

Status

Recruiting

Address

Klinikum Region Hannover GmbH Burgwedel

Hannover, ,

Site Contact

Jiezel De Guzman

jiezel.deguzman@nnuh.nhs.uk

844-723-9363

Universitaetsklinikum Leipzig, Leipzig, Germany

Status

Recruiting

Address

Universitaetsklinikum Leipzig

Leipzig, ,

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

Status

Recruiting

Address

Universitaetsklinikum Magdeburg A.oe.R.

Magdeburg, ,

Site Contact

Ines Gromeier

ines.gromeier@med.ovgu.de

844-723-9363

IRCCS Ospedale San Raffaele, Milano, Italy

Status

Recruiting

Address

IRCCS Ospedale San Raffaele

Milano, ,

Site Contact

Carmen Di Matteo

dimatteo.carmen@hsr.it

844-723-9363

Azienda Ospedale - Università Padova, Padova, Italy

Status

Recruiting

Address

Azienda Ospedale - Università Padova

Padova, ,

Site Contact

Greta Lorenzon

gretalorenzon90@gmail.com

844-723-9363

Rome, Italy

Status

Recruiting

Address

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

Rome, ,

Istituto Clinico Humanitas, Rozzano, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Rozzano, ,

Site Contact

Morena Merigo

morena.merigo@humanitas.it

844-723-9363

Salerno, Italy

Status

Recruiting

Address

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

Salerno, ,

Site Contact

Ornella De Santis

ornella.desanti@aornmoscatis.it

844-723-9363

Verona, Italy

Status

Recruiting

Address

Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

Verona, ,

Site Contact

Silvia Palmerio

Silvia.palmerio@crc.vr.it

844-723-9363

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

Status

Recruiting

Address

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

Warszawa, ,

Site Contact

Magdalena Kulis

magdalena.kulis@czmdm.pl

844-723-9363

WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland

Status

Recruiting

Address

WIP Warsaw IBD Point Profesor Kierkus

Warszawa, ,

Site Contact

Maria Ciekot

m.ciekot@wip.waw.pl

844-723-9363

Warszawa, Poland

Status

Recruiting

Address

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

Warszawa, ,

Site Contact

Oliwia Rozum-Fraczek

orozum@wim.mil.pl

844-723-9363

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

Status

Recruiting

Address

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

Łódź, ,

Site Contact

Milena Mamos

milena.myssera@gmail.com

844-723-9363

Alicante, Spain

Status

Recruiting

Address

Hospital General Universitario de Alicante Dr. Balmis

Alicante, ,

Site Contact

Alejandro Martinez

scalejandromr@gmail.com

844-723-9363

Hospital Clinico San Carlos, Madrid, Spain

Status

Recruiting

Address

Hospital Clinico San Carlos

Madrid, ,

Site Contact

Juan Pablo Fernandez Sanchez

jotape1795@gmail.com

844-723-9363

Hospital Universitario de La Princesa, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de La Princesa

Madrid, ,

Site Contact

Jennifer Fernandez Pacheco

jennifer.secrcsantander@hotmail.com

844-723-9363

Sabadell, Spain

Status

Recruiting

Address

Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

Sabadell, ,

Site Contact

Aida Gonzalez

agonzalezru01@tauli.cat

844-723-9363

Hospital Universitario Miguel Servet, Zaragoza, Spain

Status

Recruiting

Address

Hospital Universitario Miguel Servet

Zaragoza, ,

Site Contact

Laura Vicente-Manso

lvicentemanso@gmail.com

844-723-9363

St George's Hospital, London, United Kingdom

Status

Recruiting

Address

St George's Hospital

London, ,

Site Contact

Abigail Seward

abigail.seward@stgeorges.nhs.uk

844-723-9363

St. Thomas' Hospital, London, United Kingdom

Status

Recruiting

Address

St. Thomas' Hospital

London, ,

Site Contact

Francis Aguilar

Francisco.Aguilar@gstt.nhs.uk

844-723-9363

Norfolk and Norwich University Hospital, Norwich, United Kingdom

Status

Recruiting

Address

Norfolk and Norwich University Hospital

Norwich, ,

Site Contact

Ian Beales

ian.beales@nnuh.nhs.uk

844-723-9363

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