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A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

PHASE2RECRUITING

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

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Study details:

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

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
  • 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 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
  • 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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-06-01

    Primary completion: 2025-03-01

    Study completion finish: 2025-08-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT05774184

    Intervention or treatment

    BIOLOGICAL: barzolvolimab

    DRUG: Matching Placebo

    Conditions

    • Eosinophilic Esophagitis

    Find a site

    Closest Location:

    Royal Adelaide Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal Adelaide Hospital

      Adelaide, South Australia, Australia

    • The Alfred Hospital

      Melbourne, Victoria, Australia

    • St Vincent's Hospital Melbourne

      Melbourne, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    ACTIVE_COMPARATOR: Barzolvolimab (CDX-0159)
    • 300 mg subcutaneous administration every 4 weeks through week 24
    BIOLOGICAL: barzolvolimab
    • subcutaneous administration
    PLACEBO_COMPARATOR: Placebo then barzolvolimab (CDX-0159) 300mg
    • Matching placebo subcutaneous administration every 4 weeks through week 16, then 300mg subcutaneous administration every 4 weeks through week 24
    DRUG: Matching Placebo
    • subcutaneous administration

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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 outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    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)
    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)
    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)
    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)
    Incidence of Treatment Emergent Adverse Events.The rates of treatment emergent adverse events will be summarized.From first dose through Visit 14 (Week 44)

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

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