Clinical Trials

Inclusion Criteria:

• Willing and able to provide written consent.
• Male or female,  aged ≥ 18 and ≤ 80 years at the time of signing the informed consent for entry.
• Baseline endoscopic biopsy with > 30 eosinophils/hpf in 5 hpfs in the stomach and/or > 30 eosinophils/hpf in 3 hpfs in the duodenum.
• An average abdominal pain, nausea, or diarrhea score ≥ 3 on the PRO questionnaire (score from 0–10) and a TSS of ≥ 10 for at least 2 of 3 weeks of screening. If patients have an average score ≥ 3 for 2 consecutive weeks, a third week of screening is not necessary. A minimum of 4 questionnaires must be completed each qualifying week.
• Patients with inadequate or lost response to, or who were intolerant to, standard therapies, which could include PPIs, antihistamines, systemic or topical corticosteroids, and/or diet, among others.
• If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study.
• Willing and able to comply with all study procedures and visit schedule including follow-up visits.
• Negative screening for ova and parasite test in the stool and serology for Strongyloides stercoralis.
• Female patients must be either post-menopausal for at least 1 year with FSH level > 30 mIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
• Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation).

Exclusion Criteria:

• Use of systemic corticosteroids exceeding the equivalent of 10 mg/day of prednisone within 4 weeks prior to the screening visit.
• Change in the dose of topical corticosteroids, PPIs, or diet within 4 weeks prior to the screening visit.
• Treatment with any other biologics within 12 weeks prior to the screening visit.
• Prior enrollment in an AK002 clinical trial.
• Active Helicobacter pylori infection, unless treated and confirmed to be negative prior to randomization and symptoms remain consistent.
• History of inflammatory bowel disease, celiac disease, achalasia, esophageal surgery, or esophageal strictures requiring dilatation.
• History of bleeding disorders and/or esophageal varices.
• Other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA).
• Known hypersensitivity to any constituent of the study drug.
• Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
• Presence of an abnormal laboratory value considered to be clinically significant by the Investigator.
• Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
• History of malignancy, except carcinoma in situ, 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.
• Treatment for a clinically significant helminthic parasitic infection within 6 months of screening.
• Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. 16) Positive hepatitis serology results, except for vaccinated patients or patients with past but resolved hepatitis, at screening.
• Positive HIV serology results at screening.
• Known history of alcohol, drug, or other substance abuse or dependence, considered by the Investigator to be ongoing and clinically significant.
• Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment.
• Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products).