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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Eosinophilic Esophagitis
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Ability to read, understand, and provide written informed consent
    2. Documented diagnosis of Esophageal intraepithelial eosinophilic (EoE) by endoscopy
    3. Must be symptomatic, defined as:
      1. History in the last month (on average of at least 2 days per week) with difficulty swallowing solid foods and
      2. At least 4 days with difficulty swallowing within the last 2 weeks
    4. Must be on a stable diet which includes solid foods for at least 2 months prior to the Screening Visit and throughout the study.
      Note: A stable diet means you're not starting or stopping any specific food groups, or bringing back foods you stopped eating before.
    5. Females must meet one of the following criteria:
      • If of childbearing potential, agree to use highly effective contraception from the time of the Screening Visit and for at least 150 days after receipt of study treatment. Methods of contraception include:
        1. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, administered as oral, intravaginal or transdermal
        2. progestogen-only hormonal contraception associated with inhibition of ovulation administered as oral, injectable or by implantable means
        3. intrauterine device (IUD)
        4. intrauterine hormone-releasing system (IUS)
      • Females of non-childbearing potential, who are surgically sterile (i.e., had undergone complete hysterectomy, salpingectomy and bilateral oophorectomy) or in a menopausal state (at least 1 year without menstruation) are eligible.
    6. Male patients must agree that while participating in the study and for at least 150 days after start of the study treatment, they will use highly effective methods of contraception with female partners of childbearing potential, and they will not donate sperm.
      Note: Vasectomy is considered to be a highly effective method of contraception provided that the vasectomized patient has received medical assessment confirming the surgical success.
    7. Willing and able to comply with all study requirements and procedures, including the completion of a daily symptom diary during screening and throughout the study.

You may not be eligible for this study if the following are true:

    1. Diagnosis of hypereosinophilic syndrome or Churg-Strauss syndrome (or eosinophilic granulomatosis with polyangiitis).
    2. History of a clinicopathologic diagnosis of eosinophilic gastritis or eosinophilic duodenitis.
    3. Known active Helicobacter pylori infection.
    4. History of coagulation disorders or esophageal varices.
    5. History of achalasia, Crohn’s disease, ulcerative colitis or celiac disease.
    6. Esophageal dilation within 3 months prior to the Screening Visit.
    7. Avoiding solid foods or using feeding tube.
    8. Require regular use of antiplatelet and/or anticoagulant therapy.
    9. Non-biologic systemic (oral or injectable) agents within 2 months prior to the Screening Visit.
      Note: Non-biologic systemic (oral or injectable) agents include but are 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.
    10. Biologic therapy within 3 months or 5 half-lives, whichever is longer, prior to the Screening Visit.
      Note: Biologic agents include but are 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.
    11. Oral immunotherapy (OIT) within 6 months prior to the Screening Visit.
    12. Sublingual immunotherapy (SLIT) and/or subcutaneous immunotherapy (SCIT), unless have been on a stable maintenance dose for at least 6 months prior to the Screening Visit.
    13. 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).
      • Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally inactivated virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Currently authorized COVID-19 vaccines are allowed.
    14. Women who are pregnant or nursing. All female patients with reproductive potential must have a negative pregnancy test prior to starting study treatment.
    15. Severe or uncontrolled chronic diseases (e.g., chronic hepatic or renal disease, diabetes mellitus) that might interfere with the evaluation of the clinical effect or safety of study treatment.
    16. Known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
    17. Patients with active COVID-19 infection.
    18. History of malignancy within 5 years before the Screening Visit, except fully treated carcinoma in-situ of the cervix, fully treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
    19. Known active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals during the Screening period.
    20. Procedures requiring general or epidural anaesthesia within 8 weeks prior to study treatment, minor procedures (e.g., dental) within 14 days prior to study treatment, or anticipation of procedures requiring general anaesthesia during study participation.
    21. Prior receipt of barzolvolimab.
    22. Patients who live in detention on court order or on regulatory action.
    23. Sponsor or contract research organization (CRO) staff directly involved in the conduct of the study, site staff supervised by the investigator, and their respective family members.

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