A Study of CDX-0159 in Patients With Eosinophilic Esophagitis (EvolvE)

May 22, 2026 updated by: Celldex Therapeutics

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults With Active Eosinophilic Esophagitis (The "EvolvE" Study)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • St Vincent's Hospital Melbourne
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia
        • The Alfred Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University Of Calgary
    • British Columbia
      • Victoria, British Columbia, Canada
        • PerCuro Clinical Research Ltd.
  • Germany
      • Augsburg, Germany
        • Universitaetsklinikum Augsburg
      • Hanover, Germany
        • Klinikum Region Hannover GmbH Burgwedel
      • Magdeburg, Germany
        • Universitaetsklinikum Magdeburg A.oe.R.
  • Italy
      • Milan, Italy
        • IRCCS Ospedale San Raffaele
      • Rome, Italy
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
      • Rozzano, Italy
        • Istituto Clinico Humanitas
      • Salerno, Italy
        • Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona-Plesso "Ruggi"
      • Verona, Italy
        • Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
  • Poland
      • Lodz, Poland
        • Centrum Medyczne Med-Gastr Sp. z o.o.
      • Warsaw, Poland
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warsaw, Poland
        • Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante Dr. Balmis
      • Madrid, Spain
        • Hospital Clinico San Carlos
  • United Kingdom
      • London, United Kingdom
        • St George's Hospital
      • London, United Kingdom
        • St. Thomas' Hospital
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Allervie Clinical Research
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • One of a Kind Clinical Research Center
      • Sun City, Arizona, United States, 85351
        • GI Alliance- Arizona Digestive Health- Sun City
      • Tucson, Arizona, United States, 85715
        • Del Sol Research Management, LLC
    • California
      • Chula Vista, California, United States, 91910
        • GW Research Inc.
    • Connecticut
      • Bristol, Connecticut, United States, 06416
        • Connecticut Clinical Research Institute, LLC
    • Florida
      • Jacksonville, Florida, United States, 32256
        • ENCORE Borland Groover Clinical Research
      • Orange City, Florida, United States, 32763
        • Gastroenterology of Greater Orlando
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60208
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center (KUMC)
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Boston Specialists - Boston Food Allergy Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina (UNC) Hospitals
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Willoughby, Ohio, United States, 44096
        • The Clinical Trials Network, LLC
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center-GI Clinical Research Program
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute - Ogden
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
      • Salt Lake City, Utah, United States, 84124
        • Care Access Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Barzolvolimab (CDX-0159)
300 mg subcutaneous administration every 4 weeks through week 24
Biological: barzolvolimab
subcutaneous administration
Other Names:
  • CDX-0159
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
Biological: barzolvolimab
subcutaneous administration
Other Names:
  • CDX-0159
Drug: Matching Placebo
subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).
Time Frame: 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.
From baseline to Visit 6 (Week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC ≥ 12/hpf.
Time Frame: 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.
From baseline to Visit 6 (Week 12)
Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf).
Time Frame: 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.
From baseline to Visit 6 (Week 12)
Percent (%) change from baseline to Week 12 in PMC/hpf.
Time Frame: 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.
From baseline to Visit 6 (Week 12)
Incidence of Treatment Emergent Adverse Events.
Time Frame: From first dose through Visit 14 (Week 44)
The rates of treatment emergent adverse events will be summarized.
From first dose through Visit 14 (Week 44)
Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ).
Time Frame: 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.
From baseline to Visit 6 (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celldex Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

June 4, 2025

Study Completion (Actual)

January 23, 2026

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX0159-08
  • 2022-001786-12 (EudraCT Number)
  • 2024-512767-30-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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