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Eosinophilic Duodenitis clinical trials

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NCT ID: NCT05831176 Recruiting - Clinical trials for Eosinophilic Gastritis

A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

ENGAGE
Start date: May 3, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

NCT ID: NCT05152563 Withdrawn - Clinical trials for Eosinophilic Gastritis

A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis

ENIGMA-SC
Start date: December 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacodynamic effect of subcutaneous lirentelimab (AK002), given monthly for 6 doses, in subjects with moderate to severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis who have an inadequate response with, lost response to, or were intolerant to standard therapies.

NCT ID: NCT04856891 Completed - Clinical trials for Eosinophilic Gastroenteritis

A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis

EoDyssey
Start date: May 20, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult patients with active 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.

NCT ID: NCT04620811 Completed - Clinical trials for Eosinophilic Gastritis

An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

Start date: December 3, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.

NCT ID: NCT04322604 Completed - Clinical trials for Eosinophilic Gastritis

A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

ENIGMA 2
Start date: June 18, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) who have an inadequate response with, lost response to, or were intolerant to standard therapies

NCT ID: NCT03664960 Completed - Clinical trials for Eosinophilic Gastroenteritis

An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis

Start date: November 14, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.