A Study to Evaluate the Safety and Effectiveness of AK002 in Patients with Eosinophilic Gastritis and/or Eosinophilic Duodenitis

Overview

About this study

The purpose of this study is to generate open-label, longer-term safety, tolerability, and effectiveness follow-up data in patients with EG and/or EoD who completed Study AK002-016 or Study AK002-012.

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.
  • Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3 days), or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug.
  • If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study.
  • Able and willing to comply with all study procedures.
  • Female patients must be either post-menopausal for at least 1 year 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 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 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:

  • Poor tolerance to previous administration of AK002 in the opinion of the Investigator.
  • Known hypersensitivity to any constituent of the study drug.
  • Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
  • Planned or expected vaccination with live attenuated vaccines during the treatment, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
  • Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
  • Any other reason that in the opinion of the Investigator or 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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jennifer Horsley-Silva, M.D.

Contact us for the latest status

Contact information:

Pooja Bhakta B.S.

(800) 664-4542

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Open for enrollment

Contact information:

Chadrick Hinson

(507) 538-6300

Hinson.Chadrick@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available