A Study to Evaluate the Safety, Tolerability, and Activity of Escalating Doses of AK002 in Patients with Eosinophilic Gastritis (EG) and/or Eosinophilic Gastroenteritis (EGE)

Overview

About this study

The purpose of this study is to evaluate the safety, tolerability, and activity of escalating doses of AK002 in patients with Eosinophilic Gastritis (EG) and/or Eosinophilic Gastroenteritis (EGE).

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

 

  • Provide written informed consent.
  • Male or female aged ≥ 18 and ≤ 80 years at the time of signing consent.
  • Average weekly score of ≥ 3 recorded for either abdominal pain, diarrhea, and/or nausea on the PRO questionnaire during at least 2 of the last 3 weeks of PRO collection during the Screening period. A minimum of 4 questionnaires must be completed each qualifying week.
  • Eosinophilia of the gastric mucosa ≥ 30 eosinophils/HPF in 5 HPFs and/or eosinophilia of the duodenal mucosa ≥ 30 eosinophils/HPF in 3 HPFs from the EGD performed during the screening period, without any other cause for the gastric eosinophilia (e.g., parasitic or other infection or malignancy).
  • Subjects must have failed or not be adequately controlled on standard of care treatments for EG and/or EGE symptoms (including but not limited to PPIs, systemic or topical corticosteroids, and/or diet).
  • If on allowed treatments for EG and/or EGE at the time of enrollment, stable dose for at least 5 half-lives prior to screening and willingness to continue on that dose for the duration of the study.
  • If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study, as much as possible.
  • Able and willing to comply with all study procedures.
  • Female subjects must be either post-menopausal for at least 1 year with FSH level >40 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 subjects 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 at any time during study participation.

Exclusion Criteria:

 

  • Known hypersensitivity to any constituent of the study drug.
  • Previous exposure to AK002.
  • Diagnosis of celiac disease or active H. pylori infection as determined by screening EGD or a history of celiac disease diagnosed by prior EGD.
  • Diagnosis of Hypereosinophilic Syndrome (HES), based on standard criteria (blood eosinophils > 1500/μL with involvement of either the heart, nervous system, and/or bone marrow).
  • Presence of abnormal laboratory values considered by the Investigator to be clinically significant.
  • Grade 2 or higher lymphopenia (< 0.8 × 109/L lymphocytes).
  • Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the subject at increased risk.
  • History of malignancy, exempting carcinoma in situ, early stage prostate cancer, non-melanoma skin cancers, and cancers in remission for >5 years and considered cured (except for breast cancer). All history of malignancy (including diagnosis, dates, and compliance with cancer screening recommendations) must be documented and certified by the Investigator, along with the statement that in their clinical judgment the tissue eosinophilia is attributable to EGID, rather than recurrence of malignancy.
  • Treatment with chemotherapy or radiotherapy in the preceding 6 months.
  • Treatment for a clinically significant helminthic parasitic infection within 6 months of screening and/or a positive helminthic test at screening.
  • Use of any medications that may interfere with the study such as immunosuppressive or immuno-modulatory drugs (including azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, tacrolimus, anti-TNF, anti-IL-5, anti-IL-5 receptor, dupilumab, anti-IgE antibodies, omalizumab) or systemic corticosteroids with a daily dose >10 mg of prednisone or equivalent, during 5 half-lives prior to screening or during the screening period, except for omalizumab taken for asthma and/or urticaria when their asthma and/or urticaria cannot be controlled on other medications, If on omalizumab, the dose must have been stable for at least 4 weeks prior to 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 of the study drug administration.
  • Known history of alcohol, drug, or other substance abuse or dependence.
  • Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (or 90 days or 5 half-lives, whichever is longer, for biologic products).

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

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20469375

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