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AK002-003


Title A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients with Eosinophilic Gastritis with or without Eosinophilic Gastroenteritis
Therapeutic Area Eosinophilic Disorders
Principal Investigator John Leung, MD
Min Age 18 Years
Max Age 80 Years
Gender Any
Contact Teresa Brown
617-636-4941
More Information https://www.clinicaltrials.gov/ct2/show/NCT0349657

Overview

This study is being conducted to test the efficacy and safety of AK002 in patients with Eosinophilic Gastritis with or without Eosinophilic Gastroenteritis and requires nine study visits over the course of 24 weeks. Participants will receive study drug or placebo via infusion during four of these visits. 

Study Details

Inclusion Criteria

  • Eosinophilia of the gastric mucosae >30 eosinophils/HPF in 5 HPFs from the EGD performed during the screening period, without any other causes for the gastric eosinophilia (e.g. parasitic or other infection or malignancy).
  • Subjects must have failed or not be adequately controlled on standard care treatments for EG (which could include PPIs, systemic or topical corticosteriods, and/or diet, among others).
  • If on other treatments for EG, EGE, or EoE at enrollment, stable dose for at least 8 weeks prior to screening and willingness to continue on that dose for the duration of the study. [Only 4 weeks prior to screening for a proton-pump-inhibitor (PPI)].

Exclusion Criteria

  • Use during the 30 days before Screening (or 5 half-lives, whichever is longer) or use during the Screening period of any medications that may interfere with the study with as immunosupressive or immunodulatory drugs (including azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, anti-TNF, anti-IL-5, anti-IL-5 receptor, dupilumab, anti-IgE antibodies, omalizumab) or systemic corticosteroids with a daily dose >10mg of prednisone or equivalent.
  • History of malignancy; except carcinoma in situ in the cervix, early stage prostate cancer, or non-melanoma skin cancers. However, cancers that have been in remission for more than 5 years and are considered cured, can be enrolled (with exception of breast cancer). 
  • Diagnosis of celiac disease of H. pylori infection as determined by screening EGD or a history of celiac disease diagnosed by prior EGD. 

Study Requirements

This study involves nine research visits over 24 weeks, 2 endoscopies (pre-treatment and post treatment), 4 infusions, and blood draws during eight visits. No more than 62mL (~4 tablespoons) of blood will be collected on any given day. For comparison, up to 500mL of blood is collected in one day during a single blood donation.