A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Adult and Adolescent Patients with Active Eosinophilic Esophagitis (EoE)
Clinical Trial Information
Trial Contact: Coleman, Tenesha; Beltran, Yajira; Tilme, Linda
To evaluate the efficacy of AK002 in adult and adolescent patients with active EoE when compared to placebo, efficacy endpoints will be co-primary:
1) The proportion of patients who achieve a peak esophageal intraepithelial count eosinophils/hpf at Day 155 (Week 22)
2) Mean absolute change in Dysphagia Symptom Questionnaire (DSQ) score from Baseline to Weeks 21-22.
Confirmed diagnosis of EoE and intraepithelial eosinophilic infiltration of >/ eosinophils/hpf in 1hpf from the biopsy collected during the Screening EGD, without any other cause for the esophageal eosinophilia.