Back to Results

AK002-016X


Title

A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients that were Previously Enrolled in AK002-016 or AK002-012 Studies and have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis)

Therapeutic Area Eosinophilic Gastrointestinal Disorders
Principal Investigator John Leung, MD
Min Age 18 Years
Max Age 80 Years
Gender Any
Contact Selma Sinanovic & Evan Cunningham
617-636-2392
ssinanovic@tuftsmedicalcenter.org; ecunningham1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04620811

Overview

Open label extension study to the AK002-016 study where eligible participants who have completed the AK002-016 study can enroll into the AK002-016X extension study and receive additional doses of AK002.

Study Details

Inclusion Criteria

  • Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through at least Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate number of doses and followed for 5 months after last dose of study drug.

     

  • If patient is on preexisting dietary restrictions, willingness to maintain those restrictions, until the seventh dose has been received. After the seventh dose, diet may be liberalized.

     

  • Provide written informed consent

Exclusion Criteria

  • Known hypersensitivity to any constituent of the study drug
  • Poor tolerance to previous administration of AK002 in the opinion of the Investigator
  • Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.

Study Requirements

Participants will visit the clinic for an additional 6 infusions of AK002, blood will be drawn twice during every visit both prior and post drug administration. An EGD will be required at the transition point between the double blind and the open label studies. An additional EGD will be required at the end of the open label trial.