This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Phoenician Centers for Research and Innovation
Phoenix, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
Adverse events assessed using the CTCAE version 4.03
Time frame: Through study completion, up to 28 months
Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline
The PRO Total Symptom Score (TSS) is a patient-reported outcome (PRO) questionnaire comprises the following 8 symptoms: abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Individual symptom scores ranged from 0 to 10. The daily total symptom score ranged from 0 to 80, with higher scores indicating greater severity. The End of treatment TSS score is defined as the average of the 14 daily scores on or after the day of the last dose of the extension study.
Time frame: AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months)
Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline
Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline
Time frame: AK002-003 Baseline to Day 547
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Chicago, Illinois, United States
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Iowa City, Iowa, United States
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...and 7 more locations