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Enteritis clinical trials

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NCT ID: NCT05251909 Completed - Clinical trials for Eosinophilic Gastroenteritis

Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

HUDSON GI
Start date: January 18, 2022
Phase: Phase 3
Study type: Interventional

This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close enrollment, patients in both Part A and Part C will be given the option to proceed to 6-months of open-label benralizumab treatment in Part D.

NCT ID: NCT05045833 Completed - Clinical trials for Enteritis Caused by Radiation

Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020

Start date: October 18, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-ascending-dose study to assess the PK, safety, and tolerability of SYN-020 oral delayed release capsules (SYN 020) in healthy adults. At least 1 exploratory PD endpoint will also be assessed.

NCT ID: NCT04815993 Completed - Clinical trials for Enteritis Caused by Radiation (Disorder)

Pharmacokinetics, Safety, and Tolerability of SYN-020

Start date: March 22, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will receive doses that were well tolerated in an earlier cohort to determine the effect of BMI and/or a high-fat meal on the SYN-020 PK profile. For each cohort, eligible subjects will be admitted to the clinic on Day -1, and receive study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be discharged from the clinic after the End of Study procedures are completed on Day 6.

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.

NCT ID: NCT03496571 Completed - Clinical trials for Eosinophilic Gastroenteritis

A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

ENIGMA
Start date: July 18, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).

NCT ID: NCT03473977 Completed - Clinical trials for Eosinophilic Gastritis or Gastroenteritis

Benralizumab for Eosinophilic Gastritis (BEGS)

BEGS
Start date: April 23, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Benralizumab (Anti-IL5RA) in Subjects With Eosinophilic Gastritis.

NCT ID: NCT03320369 Completed - Clinical trials for Eosinophilic Gastroenteritis

Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

Start date: September 5, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis

NCT ID: NCT02897271 Completed - Clinical trials for Eosinophilic Esophagitis

Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort

Start date: August 2016
Phase:
Study type: Observational

The purpose of this study is to investigate features of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).