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1/1/2099


Title A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Adult and Adolescent Patients with Active Eosinophilic Esophagitis
Therapeutic Area Eosinophilic Esophagitis
Principal Investigator John Leung, MD
Min Age 12 Years
Max Age 80 Years
Gender All
Contact Selma Sinanovic
617-636-2392
ssinanovic@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04322708

Overview

Participation during screening will last no less than 2 weeks and no more than 4 weeks. If you qualify for the study, you will participate for 7 additional months if you participate in only the randomized, double-blind, placebo-controlled part of the study or 13 additional months (if you complete the randomized, double-blind, placebo-controlled part of the study and decide to participate in an extended dosing period during which all participants receive 6 doses of AK002. Therefore, the total period of participation is approximately 8 months or 14 months.

If you are eligible and choose to participate in the OLE Period of the study, you will participate in the randomized, double-blind, placebo-controlled part of the study for approximately 24 weeks and will complete study visits through the Day 155 visit. You will begin following the OLE Period schedule and extended dosing at the Day 169 visit.

Overall, approximately 300 men and women 12 to 80 years of age are expected to be enrolled in this study which is being conducted at approximately 60 sites.

Study Details

Inclusion Criteria

  • Confirmed diagnosis of EoE and intraepithelial eosinophilic infiltration of ≥15 eosinophils/hpf in 1 hpf from the biopsy collected during the Screening EGD, without any other cause for the esophageal eosinophilia.
  • Subjects must have failed or not be adequately controlled on standard of care treatments for EoE symptoms, which could include PPI, systemic or topical corticosteroids, and/or diet, among others.
  • History (by patient report) of an average of ≥2 episodes of dysphagia with intake of solid foods per week during the 4 weeks prior to Screening.

Exclusion Criteria

  • Concomitant EG, EGE, or eosinophilic colitis (EC).* * Except EoE patients that were screened and did not meet symptom or histology inclusion criteria for the AK002-016 (Phase 3 EG/EGE) study.
  • Causes of esophageal eosinophilia other than EoE or one the following: hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, or peripheral blood absolute eosinophil count >1500 eosinophils/μL.
  • Use of any biologics or medications that may interfere with the study such as immunosuppressive or immunomodulatory drugs including azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, tacrolimus, anti-TNF, anti-IL-4 receptor (e.g., dupilumab), anti-IL-5 (e.g., mepolizumab), anti-IL-5 receptor (e.g., benralizumab), anti-IL-13 (e.g., lebrikizumab), anti-IgE (e.g., omalizumab) or systemic corticosteroids with daily dose >10 mg prednisone or equivalent, during 5 half-lives or 12 weeks, whichever is shorter, prior to or during the Screening period.
    • Omalizumab, at a stable dose for at least 4 weeks prior to Screening, is allowed for asthma and/or urticaria when asthma and/or urticaria cannot be controlled on other medications.

Study Requirements

Total study duration is approximately 34–36 weeks, although the study duration could be extended if the absolute lymphocyte and/or eosinophil counts have not recovered by Day 225. There are 6 infusions scheduled in this study and 6 open label extension days. Visits will last between 2-6 hours. There are 12 blood draws scheduled in this study, total volume 258mL. There is one EKG scheduled and 2 EGD’s scheduled in this study.