6 doses of AK002 (or placebo) IV infusion q4 weeks x 6
300 patients randomized 1:1:1 to receive 1 of 3 dose regimens:
-
- placebo
- low dose regimen (1 mg/kg AK002 every 4 weeks for 6 doses)
- high dose regimen (1 mg/kg AK002 for 1st dose followed by 3 mg/kg AK002)
Total study duration is approximately 30–33 weeks (or 55–58 weeks for
subjects participating in the OLE Period)
Criteria:
- EoE and ≥15 eos/hpf in 1 hpf from a biopsy
- Patient report of average of ≥2 episodes of dysphagia with solid foods/week during the 4 weeks prior to Screening.
- A biweekly average DSQ score of ≥12 from the last 2 weeks of Screening
- Excl: Use of swallowed or oral corticosteroids within 8 weeks prior to Screening.
