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A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of Subcutaneous AK002 in Subjects With Moderate to Severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis

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Trial Profile

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of Subcutaneous AK002 in Subjects With Moderate to Severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2023

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At a glance

  • Drugs Lirentelimab (Primary)
  • Indications Duodenitis; Eosinophilic gastroenteritis
  • Focus Therapeutic Use
  • Acronyms ENIGMA-SC
  • Sponsors Allakos
  • Most Recent Events

    • 02 Mar 2023 Planned End Date changed from 1 Aug 2024 to 20 Jan 2022.
    • 02 Mar 2023 Planned primary completion date changed from 1 Jan 2024 to 20 Jan 2022.
    • 02 Mar 2023 Status changed from recruiting to withdrawn prior to enrolment.

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