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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard Therapies

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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard Therapies

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jan 2024

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At a glance

  • Drugs Lirentelimab (Primary)
  • Indications Duodenitis
  • Focus Therapeutic Use
  • Acronyms EoDyssey
  • Sponsors Allakos

    • Most Recent Events

    • 30 Mar 2023 Status changed from active, no longer recruiting to completed.
    • 09 Sep 2022 Primary endpoint (Mean absolute change in 6 symptom total symptom score (TSS: abdominal pain, nausea, abdominal cramping, loss of appetite, fullness before finishing a meal, and bloating ) as measured by the PRO questionnaire (score from 0 none - 10 worst)) has not been met, according to an Allakos media release.
    • 09 Sep 2022 Primary endpoint (Proportion of Responders, where a responder is a patient achieving a mean peak duodenal eosinophil count 15 cells/3 duodenal hpf.) has been met, according to an Allakos media release.

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