Allakos, Inc is conducting the clinical trial of Lirentelimab (AK002) for Eosinophilic Duodenitis

 

Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.

It is planned to include 80 participants.

Actual study start date is April 2021. The researchers expect to complete the study by July 2022.

One primary outcome measure is 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).

Inclusion and exclusion criteria, as well as further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT04856891.

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