A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

Key Inclusion Criteria:

1. Provide written informed consent.
2. Male or female aged ≥18 and ≤80 years at the time of signing the informed consent forentry.
3. Baseline endoscopic biopsy with ≥30 eosinophils/hpf in 5 hpf in the stomach and/or ≥30eosinophils/hpf in 3 hpf in the duodenum, as determined by central histologyassessment of biopsies collected during the screening EGD.
4. Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeksduring screening.
5. Patients with inadequate or loss of response to, or who were intolerant to standardtherapies for EG/EoD symptoms, which could include PPI, antihistamines, systemic ortopical corticosteroids, and/or diet, among others.
6. If patient is on pre-existing dietary restrictions, willingness to maintain dietaryrestrictions throughout the study.
7. Willing and able to comply with all study procedures and visit schedule includingfollow-up visits.
8. Female patients must be either post-menopausal for at least 1 year with FSH level >30mIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateraloophorectomy) for at least 3 months, or if of childbearing potential, have a negativepregnancy test and agree to use dual methods of contraception, or abstain from sexualactivity from screening until the end of the study, or for 120 days following the lastdose of study drug, whichever is longer. Male patients with female partners ofchildbearing potential must agree to use a highly effective method of contraceptionfrom screening until the end of the study or for 120 days following the last dose ofstudy drug, whichever is longer. All fertile men with female partners of childbearingpotential should be instructed to contact the Investigator immediately if they suspecttheir partner might be pregnant (e.g., missed or later menstrual period) at any timeduring study participation.

Key Exclusion Criteria:

1. Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day ofprednisone within 4 weeks prior to the screening visit.
2. Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, ordiet therapy within 4 weeks prior to the screening visit.
3. Treatment with any immunosuppressive or immunomodulatory drugs that may interfere withthe study within 12 weeks prior to the screening visit.
4. Prior exposure to AK002 or known hypersensitivity to any constituent of the studydrug.
5. Active Helicobacter pylori infection, unless treated and confirmed to be negativeprior to randomization and symptoms remain consistent.
6. History of inflammatory bowel disease, celiac disease, achalasia, or esophagealsurgery.
7. History of bleeding disorders and/or esophageal varices.
8. Other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosiswith polyangiitis (EGPA).
9. Confirmed diagnosis of Hypereosinophilic Syndrome (HES).
10. Women who are pregnant, breastfeeding, or planning to become pregnant whileparticipating in the study.
11. Presence of an abnormal laboratory value considered to be clinically significant bythe Investigator.
12. Any disease, condition (medical or surgical), or cardiac abnormality, which, in theopinion of the Investigator, would place the patient at increased risk.
13. History of malignancy, except carcinoma in situ, early stage prostate cancer, ornon-melanoma skin cancers. However, cancers that have been in remission for more than 5 years and are considered cured, can be enrolled (with the exception of breastcancer).
14. Treatment for a clinically significant helminthic parasitic infection within 6 monthsof screening.
15. Positive Ova and Parasite (O&P) test and/or seropositive for Strongyloidesstercoralis.
16. Vaccination with live attenuated vaccines within 30 days prior to initiation oftreatment in the study, during the treatment period, or vaccination expected within 5half-lives (4 months) of study drug administration.
17. Seropositive for HIV or hepatitis at screening, except for vaccinated patients orpatients with past but resolved hepatitis, at screening.
18. Participation in a concurrent interventional study with the last interventionoccurring within 30 days prior to study drug administration (or 90 days or 5half-lives, whichever is longer, for biologic products).
19. Known history of alcohol, drug, or other substance abuse or dependence, considered bythe Investigator to be ongoing and clinically significant.
20. Any other reason that in the opinion of the Investigator or the Medical Monitor makesthe patient unsuitable for enrollment.