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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05774184
Recruitment Status : Recruiting
First Posted : March 17, 2023
Last Update Posted : April 2, 2024
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

Tracking Information
First Submitted Date  ICMJE March 7, 2023
First Posted Date  ICMJE March 17, 2023
Last Update Posted Date April 2, 2024
Actual Study Start Date  ICMJE June 1, 2023
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2023)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2023)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2023)
  • Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ). [ Time Frame: From baseline to Visit 6 (Week 12) ]
    DSQ is a validated daily patient-reported outcome to specifically measure the frequency and severity of dysphagia symptoms associated with eosinophilic esophagitis.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE
  • Biological: barzolvolimab
    subcutaneous administration
  • Drug: Matching Placebo
    subcutaneous administration
Study Arms  ICMJE
  • Active Comparator: Barzolvolimab (CDX-0159)
    300 mg subcutaneous administration every 4 weeks through week 24
    Intervention: Biological: barzolvolimab
  • 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
    Intervention: Drug: Matching Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2024)		 75
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2023)		 60
Estimated Study Completion Date  ICMJE August 2025
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Celldex Therapeutics 844-723-9363 info@celldex.com
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05774184
Other Study ID Numbers  ICMJE CDX0159-08
2022-001786-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Celldex Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Celldex Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Celldex Therapeutics
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP