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Double-Blinded Placebo controlled study for Adolescent and Adults

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

  • IRB No: 19.274.11

    Protocol Abbrev: Allakos AK002-014

    Principal Investigator: Yamen Smadi, MD

    Phase: Drug: Phase II

    Age Group: Adult;Pediatric

    Secondary Protocol No: AK002-014

    Treatment: Drug: AK002 and Placebo

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT04322708

  • Objective

    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 2) Mean absolute change in Dysphagia Symptom Questionnaire (DSQ) score from Baseline to Weeks 21-22.

  • Key Eligibility

    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.