A Study to Evaluate the Safety and Effectiveness of AK002 in Patients with Active Eosinophilic Gastritis

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of 4 doses of AK002 in patients with moderate to severe EG and/or EGE when compared to placebo.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Provide written informed 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 hpf in the stomach and/or ≥ 30 eosinophils/hpf in 3 hpf in the duodenum, as determined by central histology assessment of biopsies collected during the screening EGD, without any significant cause for the eosinophilia.
  • Prior EGD may be used for eligibility as long as the EGD occurred within 30 days of the first screening visit for the AK002-016 study and was performed and centrally assessed as for the AK002-016 study.
  • Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.
  • A weekly average score of abdominal pain, nausea, and/or diarrhea ≥ 3 on the PRO questionnaire (score from 0–10) and a weekly average TSS of ≥ 10 for at least 2 weeks of screening.
  • Patients with inadequate or loss of response to, or who were intolerant to standard therapies for EG/EoD symptoms which could include PPI, 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.
  • 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 or topical corticosteroids exceeding the equivalent of 10 mg/day of prednisone within 4 weeks prior to the screening visit.
  • Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to screening.
  • Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit.
  • Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug.
  • Active Helicobacter pylori infection, unless treated and confirmed to be negative prior to randomization and histology per repeat EGD and symptoms still qualify for enrollment after treatment.
  • Confirmed history of inflammatory bowel disease, celiac disease, achalasia, or esophageal surgery.
  • History of bleeding disorders and/or esophageal varices considered to be clinically significant by the Investigator.
  • Other significant causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA).
  • Confirmed diagnosis of Hypereosinophilic Syndrome (HES).
  • 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.
  • Positive helminthic infection on Ova and Parasite (O&P) test.
  • Seropositive for Strongyloides stercoralis at screening, except for patients with past but resolved disease.
  • Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved disease.
  • 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. All types and formulations of vaccines (including live attenuated vaccines) authorized by FDA or other regulatory authority for the prevention of COVID-19 may be administered before, during, or after this study. The vaccine should not be administered within 7 days prior to and within 7 days after the administration of AK002 so that any side effects caused by either of the 2 medications can be more easily determined.
  • 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.
  • Known history of alcohol, drug, or other substance abuse or dependence that is 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Open for enrollment

Contact information:

Chadrick Hinson

(507) 266-0237

Hinson.Chadrick@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jennifer Horsley-Silva, M.D.

Open for enrollment

Contact information:

Pooja Bhakta B.S.

(800) 664-4542

Bhakta.Pooja@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available