Ensayos clínicos

Overview

Información sobre este estudio

The primary objective of this study is to evaluate markers of eosinophilic inflammation in the esophagus longitudinally in subjects on milk oral immunotherapy (OIT) or placebo.

This is a companion study to a parent clinical trial which is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in subjects aged 4 to 50 years inclusive who are allergic to milk. The parent study consists of a screening period, a 24-week treatment period, which includes 4 weeks of pre-treatment with dupilumab or placebo followed by 12 weeks of treatment with dupilumab or placebo in combination with a gradual up-dosing of milk protein OIT, then followed by 8 weeks of milk OIT dosing with no dupilumab or placebo.  This study will examine markers of esophageal inflammation during the parent study using a non-invasive testing device, the esophageal string test (EST).

No dupilumab data will be reported to the FDA for this string test study.

The EnteroTracker® is an FDA-registered and listed Class I, 510(k) exempt medical device which is available for sale and use in the United States.  While is currently marketed for diagnosis and monitoring of EoE, the device (i.e. string test) itself was initially developed and used for detection of giardia infection and collection of duodenal bile and was referred to as the Entero-Test.  Enterotracker® combines the string test device with Lab-Developed Tests (LDTs) for EoE-associated disease biomarkers validated under CAP/CLIA standards (LDTs performed by Cambridge Biomedical Inc. CAP Accreditation (LAP# 7191028) CLIA Accreditation (ID# 22D0926993) FDA Registration (3003006583)).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Sedes participantes de Mayo Clinic

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