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New shot could ease swallowing for eosinophilic esophagitis patients

NCT ID NCT05774184

Disease control Sponsor: Celldex Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a biologic drug called barzolvolimab in 86 adults with active eosinophilic esophagitis, a condition that causes trouble swallowing due to inflammation in the esophagus. Participants received either the drug or a placebo as a shot under the skin. The study measured changes in mast cell counts in the esophagus and symptom scores to see if the drug can reduce inflammation and improve swallowing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
barzolvolimab (a biologic drug given as a shot under the skin)
What this could lead to
If it works, this could point toward a new treatment option for eosinophilic esophagitis that reduces inflammation and improves swallowing.
What could go wrong
This is a small, early phase 2 trial with only 86 participants. The results may not apply to everyone, and the drug might not work better than placebo or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

86 people

The number who actually took part.

Started

Jun 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

eosinophilic esophagitis esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic esophagitis

Contacts and locations

Locations

  • Advanced Research Institute - Ogden

    Ogden, Utah, 84405, United States

  • AllerVie Clinical Research

    Birmingham, Alabama, 35209, United States

  • Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

    Verona, Italy

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

    Salerno, Italy

  • Boston Specialists - Boston Food Allergy Center

    Boston, Massachusetts, 02111, United States

  • Care Access Research

    Salt Lake City, Utah, 84124, United States

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

    Lodz, Poland

  • Connecticut Clinical Research Institute, LLC

    Bristol, Connecticut, 06416, United States

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • ENCORE Borland Groover Clinical Research

    Jacksonville, Florida, 32256, United States

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

    Rome, Italy

  • GI Alliance- Arizona Digestive Health- Sun City

    Sun City, Arizona, 85351, United States

  • GW Research Inc.

    Chula Vista, California, 91910, United States

  • Gastroenterology of Greater Orlando

    Orange City, Florida, 32763, United States

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital General Universitario de Alicante Dr. Balmis

    Alicante, Spain

  • IRCCS Ospedale San Raffaele

    Milan, Italy

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Klinikum Region Hannover GmbH Burgwedel

    Hanover, Germany

  • NYU Langone Health

    New York, New York, 10016, United States

  • Norfolk and Norwich University Hospital

    Norwich, United Kingdom

  • Northwestern University

    Chicago, Illinois, 60208, United States

  • One of a Kind Clinical Research Center

    Scottsdale, Arizona, 85258, United States

  • PerCuro Clinical Research Ltd.

    Victoria, British Columbia, Canada

  • Royal Adelaide Hospital

    Adelaide, South Australia, Australia

  • St George's Hospital

    London, United Kingdom

  • St Vincent's Hospital Melbourne

    Melbourne, Australia

  • St. Thomas' Hospital

    London, United Kingdom

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • The Alfred Hospital

    Melbourne, Victoria, Australia

  • The Clinical Trials Network, LLC

    Willoughby, Ohio, 44096, United States

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

    Hershey, Pennsylvania, 17033, United States

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Universitaetsklinikum Augsburg

    Augsburg, Germany

  • Universitaetsklinikum Magdeburg A.oe.R.

    Magdeburg, Germany

  • University of Calgary

    Calgary, Alberta, Canada

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160, United States

  • University of North Carolina (UNC) Hospitals

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Vanderbilt University Medical Center-GI Clinical Research Program

    Nashville, Tennessee, 37232, United States

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, Poland

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

    Warsaw, Poland

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