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

Primary Purpose

Eosinophilic Esophagitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
barzolvolimab
Matching Placebo
Sponsored by
Celldex Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring barzolvolimab, esophagitis, EoE, mast cells, CDX-0159

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria ≥ 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 Key Exclusion Criteria 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 3 months or 5 half-lives (whichever is shorter) 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 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 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 There may be additional criteria your study doctor will review with you to confirm eligibility

Sites / Locations

  • GI Alliance- Arizona Digestive Health- Sun CityRecruiting
  • Del Sol Research Management, LLCRecruiting
  • Gw research Inc.Recruiting
  • Connecticut Clinical Research Institute, LLCRecruiting
  • University of Florida (UF) - JacksonvilleRecruiting
  • ENCORE Borland Groover Clinical ResearchRecruiting
  • Gastroenterology of Greater OrlandoRecruiting
  • Treasure Valley Medical ResearchRecruiting
  • University of IowaRecruiting
  • Tandem Clinical ResearchRecruiting
  • Boston Specialists - Boston Food Allergy CenterRecruiting
  • University of North Carolina (UNC) HospitalsRecruiting
  • The Clinical Trials Network, LLCRecruiting
  • University of PennsylvaniaRecruiting
  • Vanderbilt University Medical Center-GI Clinical Research ProgramRecruiting
  • Care Access ResearchRecruiting
  • Klinikum Region Hannover GmbH BurgwedelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Barzolvolimab (CDX-0159)

Placebo then barzolvolimab (CDX-0159) 300mg

Arm Description

300 mg subcutaneous administration every 8 weeks through week 24

Matching placebo subcutaneous administration every 8 weeks through week 16, then 300mg subcutaneous administration every 8 weeks through week 24

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Incidence of Treatment Emergent Adverse Events.
The rates of treatment emergent adverse events will be summarized.

Full Information

First Posted
March 7, 2023
Last Updated
October 10, 2023
Sponsor
Celldex Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05774184
Brief Title
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Acronym
EvolvE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
barzolvolimab, esophagitis, EoE, mast cells, CDX-0159

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Barzolvolimab (CDX-0159)
Arm Type
Active Comparator
Arm Description
300 mg subcutaneous administration every 8 weeks through week 24
Arm Title
Placebo then barzolvolimab (CDX-0159) 300mg
Arm Type
Placebo Comparator
Arm Description
Matching placebo subcutaneous administration every 8 weeks through week 16, then 300mg subcutaneous administration every 8 weeks through week 24
Intervention Type
Biological
Intervention Name(s)
barzolvolimab
Intervention Description
subcutaneous administration
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
subcutaneous administration
Primary Outcome Measure Information:
Title
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).
Description
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.
Time Frame
From baseline to Visit 6 (Week 12)
Secondary Outcome Measure Information:
Title
Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ).
Description
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.
Time Frame
From baseline to Visit 6 (Week 12)
Title
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC ≥ 12/hpf.
Description
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.
Time Frame
From baseline to Visit 6 (Week 12)
Title
Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf).
Description
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.
Time Frame
From baseline to Visit 6 (Week 12)
Title
Percent (%) change from baseline to Week 12 in PMC/hpf.
Description
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.
Time Frame
From baseline to Visit 6 (Week 12)
Title
Incidence of Treatment Emergent Adverse Events.
Description
The rates of treatment emergent adverse events will be summarized.
Time Frame
From first dose through Visit 14 (Week 44)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria ≥ 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 Key Exclusion Criteria 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 3 months or 5 half-lives (whichever is shorter) 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 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 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 There may be additional criteria your study doctor will review with you to confirm eligibility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celldex Therapeutics
Phone
844-723-9363
Email
info@celldex.com
Facility Information:
Facility Name
GI Alliance- Arizona Digestive Health- Sun City
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Petersen
Email
cpetersen@arizonadigestivehealth.com
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayeli Lopez
Email
nlopez@delsolresearch.com
Facility Name
Gw research Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Osorio
Email
crc8@gwresearch.net
Facility Name
Connecticut Clinical Research Institute, LLC
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile Guttermuth
Email
cguttermuth@connecticutgi.org
Facility Name
University of Florida (UF) - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Jackman
Email
kelly.jackman@jax.ufl.edu
Facility Name
ENCORE Borland Groover Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Wolfer
Email
jawolfer@encoredocs.com
Facility Name
Gastroenterology of Greater Orlando
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parteek Sharma
Email
psharma@gastro-md.com
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Gil
Email
sgil@tvmedresearch.com
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Hoover
Email
ethan-hoover@uiowa.edu
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Valence
Email
bvalence@tandemclinicalresearch.com
Facility Name
Boston Specialists - Boston Food Allergy Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Solecki
Email
rachel.s@bfac.org
Facility Name
University of North Carolina (UNC) Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gracie Whitley
Email
gracie_whitley@med.unc.edu
Facility Name
The Clinical Trials Network, LLC
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisha Lewis
Email
MarishaL@greatlakesgastro.net
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen DeMarshall
Email
demarshm@pennmedicine.upenn.edu
Facility Name
Vanderbilt University Medical Center-GI Clinical Research Program
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larry Raber
Email
larry.w.raber@vumc.org
Facility Name
Care Access Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Gamble
Email
l.gamble@careaccess.com
Facility Name
Klinikum Region Hannover GmbH Burgwedel
City
Hannover
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebru Akcivan
Email
ebru.akcivan@krh.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

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