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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05774184
Other study ID # CDX0159-08
Secondary ID 2022-001786-12
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2023
Est. completion date August 2025

Study information

Verified date June 2024
Source Celldex Therapeutics
Contact Celldex Therapeutics
Phone 844-723-9363
Email info@celldex.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date August 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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-? 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
barzolvolimab
subcutaneous administration
Drug:
Matching Placebo
subcutaneous administration

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia St Vincent's Hospital Melbourne Melbourne
Australia The Alfred Hospital Melbourne Victoria
Canada University of Calgary Calgary Alberta
Canada PerCuro Clinical Research Ltd. Victoria British Columbia
Germany Universitaetsklinikum Augsburg Augsburg
Germany Klinikum Region Hannover GmbH Burgwedel Hannover
Germany Universitaetsklinikum Leipzig Leipzig
Germany Universitaetsklinikum Magdeburg A.oe.R. Magdeburg
Italy IRCCS Ospedale San Raffaele Milano
Italy Azienda Ospedale - Università Padova Padova
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore Rome
Italy Istituto Clinico Humanitas Rozzano
Italy Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona-Plesso "Ruggi" Salerno
Italy Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma Verona
Poland Centrum Medyczne Med-Gastr Sp. z o.o. Lódz
Poland Centrum Zdrowia MDM - EB Group Sp. z o.o Warszawa
Poland WIP Warsaw IBD Point Profesor Kierkus Warszawa
Poland Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob Warszawa
Spain Hospital General Universitario de Alicante Dr. Balmis Alicante
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Universitario de La Princesa Madrid
Spain Corporacio Sanitaria Parc Tauli - Hospital de Sabadell Sabadell
Spain Hospital Universitario Miguel Servet Zaragoza
United Kingdom St George's Hospital London
United Kingdom St. Thomas' Hospital London
United Kingdom Norfolk and Norwich University Hospital Norwich
United States AllerVie Clinical Research Birmingham Alabama
United States Treasure Valley Medical Research Boise Idaho
United States Boston Specialists - Boston Food Allergy Center Boston Massachusetts
United States Connecticut Clinical Research Institute, LLC Bristol Connecticut
United States University of North Carolina (UNC) Hospitals Chapel Hill North Carolina
United States Northwestern University Chicago Illinois
United States GW Research Inc. Chula Vista California
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Duke University Medical Center Durham North Carolina
United States The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center Hershey Pennsylvania
United States University of Iowa Iowa City Iowa
United States ENCORE Borland Groover Clinical Research Jacksonville Florida
United States University of Florida (UF) - Jacksonville Jacksonville Florida
United States University of Kansas Medical Center (KUMC) Kansas City Kansas
United States Tandem Clinical Research Marrero Louisiana
United States Vanderbilt University Medical Center-GI Clinical Research Program Nashville Tennessee
United States NYU Langone Health New York New York
United States Advanced Research Institute - Ogden Ogden Utah
United States Gastroenterology of Greater Orlando Orange City Florida
United States University of Pennsylvania Philadelphia Pennsylvania
United States Care Access Research Salt Lake City Utah
United States University of Utah Salt Lake City Utah
United States One of a Kind Clinical Research Center Scottsdale Arizona
United States GI Alliance- Arizona Digestive Health- Sun City Sun City Arizona
United States Del Sol Research Management, LLC Tucson Arizona
United States The Clinical Trials Network, LLC Willoughby Ohio

Sponsors (1)

Lead Sponsor Collaborator
Celldex Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

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