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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

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Trial Profile

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Jan 2024

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At a glance

  • Drugs Lirentelimab (Primary)
  • Indications Eosinophilic gastroenteritis
  • Focus Therapeutic Use
  • Acronyms ENIGMA
  • Sponsors Allakos

    • Most Recent Events

    • 27 Oct 2021 Results of an analysis compared symptom responses of patients with new diagnoses (de novo patients) with those of patients with prior diagnoses of EG and/or EoD to lirentelimab in ENIGMA and an open-label extension study.presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021
    • 23 May 2021 Results of an analysis assessing the endoscopic findings in subjects with EG and to compare them to those of symptomatic individuals without EG using screening data from a randomized, controlled trial of lirentelimab (AK002) presented at the Digestive Disease Week 2021
    • 23 May 2021 Results of analysis assessing rates of diagnosis and define number of biopsies required to optimize EG/EoD detection using screening data from this trial presented at the Digestive Disease Week 2021
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