A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

NCT05774184 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: CDX0159-082022-001786-122024-512767-30-00
• Study Type: interventional
• Target: 86
• Locations: 8 countries
• Sites: 45

Brief Summary

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

Conditions

Eosinophilic Esophagitis

Keywords

barzolvolimab; esophagitis; EoE; mast cells; CDX-0159

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).

  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 Outcomes (5)

• Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ).

  From baseline to Visit 6 (Week 12)

• Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC ≥ 12/hpf.

  From baseline to Visit 6 (Week 12)

• Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf).

  From baseline to Visit 6 (Week 12)

• Percent (%) change from baseline to Week 12 in PMC/hpf.

  From baseline to Visit 6 (Week 12)

• Incidence of Treatment Emergent Adverse Events.

  From first dose through Visit 14 (Week 44)

Study Arms (2)

Barzolvolimab (CDX-0159)

ACTIVE COMPARATOR

300 mg subcutaneous administration every 4 weeks through week 24

Biological: barzolvolimab

Placebo then barzolvolimab (CDX-0159) 300mg

PLACEBO COMPARATOR

Matching placebo subcutaneous administration every 4 weeks through week 16, then 300mg subcutaneous administration every 4 weeks through week 24

Drug: Matching Placebo

Interventions

barzolvolimab BIOLOGICAL

subcutaneous administration

Barzolvolimab (CDX-0159)

Matching Placebo DRUG

subcutaneous administration

Placebo then barzolvolimab (CDX-0159) 300mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Documented diagnosis of eosinophilic esophagitis (EoE) by endoscopy
• 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
• 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
• On a stable diet which includes solid foods for ≥ 2 months prior to Screening (and throughout the study)
• 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)
• Willing to be compliant with completion of daily questionnaire

You may not qualify if:

• Diagnosed with hypereosinophilic syndrome or Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis)
• History of clinicopathologic diagnosis of eosinophilic gastritis or eosinophilic duodenitis
• Known active Helicobacter pylori infection
• History of coagulation disorders, esophageal varices, achalasia, Crohn's disease, ulcerative colitis, or celiac disease
• Esophageal dilation within 3 months prior to Screening
• Prior esophageal or gastric surgery that would confound the assessments of EoE
• 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
• Avoiding solid foods or using a feeding tube
• Regular use of antiplatelet and/or anticoagulant therapy
• 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
• 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
• Oral immunotherapy (OIT) within 6 months prior to Screening
• 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).
• 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
• Prior receipt of barzolvolimab

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (45)

AllerVie Clinical Research

Birmingham, Alabama, 35209, United States

Location

One of a Kind Clinical Research Center

Scottsdale, Arizona, 85258, United States

Location

GI Alliance- Arizona Digestive Health- Sun City

Sun City, Arizona, 85351, United States

Location

Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States

Location

GW Research Inc.

Chula Vista, California, 91910, United States

Location

Connecticut Clinical Research Institute, LLC

Bristol, Connecticut, 06416, United States

Location

ENCORE Borland Groover Clinical Research

Jacksonville, Florida, 32256, United States

Location

Gastroenterology of Greater Orlando

Orange City, Florida, 32763, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Northwestern University

Chicago, Illinois, 60208, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, 66160, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Boston Specialists - Boston Food Allergy Center

Boston, Massachusetts, 02111, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

University of North Carolina (UNC) Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Clinical Trials Network, LLC

Willoughby, Ohio, 44096, United States

Location

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

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center-GI Clinical Research Program

Nashville, Tennessee, 37232, United States

Location

Advanced Research Institute - Ogden

Ogden, Utah, 84405, United States

Location

Care Access Research

Salt Lake City, Utah, 84124, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

St Vincent's Hospital Melbourne

Melbourne, Australia

Location

University of Calgary

Calgary, Alberta, Canada

Location

PerCuro Clinical Research Ltd.

Victoria, British Columbia, Canada

Location

Universitaetsklinikum Augsburg

Augsburg, Germany

Location

Klinikum Region Hannover GmbH Burgwedel

Hanover, Germany

Location

Universitaetsklinikum Magdeburg A.oe.R.

Magdeburg, Germany

Location

IRCCS Ospedale San Raffaele

Milan, Italy

Location

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

Rome, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

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

Salerno, Italy

Location

Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

Verona, Italy

Location

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

Lodz, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Location

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

Warsaw, Poland

Location

Hospital General Universitario de Alicante Dr. Balmis

Alicante, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

St George's Hospital

London, United Kingdom

Location

St. Thomas' Hospital

London, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Esophagitis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 17, 2023
• Study Start: June 1, 2023
• Primary Completion: June 4, 2025
• Study Completion: January 23, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

IT (5); US (24); CA (2); PL (3); ES (2); GB (3); DE (3); AU (3)