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

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ClinicalTrials.gov Identifier: NCT05774184
Recruitment Status : Recruiting
First Posted : March 17, 2023
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

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

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Biological: barzolvolimab Drug: Matching Placebo Phase 2

Detailed Description:
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Barzolvolimab (CDX-0159)
300 mg subcutaneous administration every 8 weeks through week 24
 Biological: barzolvolimab
subcutaneous administration
Placebo Comparator: Placebo then barzolvolimab (CDX-0159) 300mg
Matching placebo subcutaneous administration every 8 weeks through week 16, then 300mg subcutaneous administration every 8 weeks through week 24
 Drug: Matching Placebo
subcutaneous administration


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
  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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05774184


Contacts
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Contact: Celldex Therapeutics 844-723-9363 info@celldex.com

Locations
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Sponsors and Collaborators
Celldex Therapeutics
More Information
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Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT05774184    
Other Study ID Numbers: CDX0159-08
2022-001786-12 ( EudraCT Number )
First Posted: March 17, 2023    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celldex Therapeutics:
barzolvolimab
esophagitis
EoE
mast cells
CDX-0159
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases