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A Study of Antolimab (AK002) in Patients With Active Eosinophilic Esophagitis

2020-03-29 04:04:38 | BioPortfolio

Summary

This is a Phase 2/3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of antolimab (AK002) given monthly for 6 doses in adult and adolescent patients with active eosinophilic esophagitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label antolimab (AK002) through the OLE Period of the study.

Study Design

Conditions

Eosinophilic Esophagitis

Intervention

Placebo, antolimab (AK002)

Location

Allakos Investigational Site
Huntsville
Alabama
United States
38801

Status

Recruiting

Source

Allakos, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-29T04:04:38-0400

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Medical and Biotech [MESH] Definitions

Chronic ESOPHAGITIS characterized by esophageal mucosal EOSINOPHILIA. It is diagnosed when an increase in EOSINOPHILS are present over the entire esophagus. The reflux symptoms fail to respond to PROTON PUMP INHIBITORS treatment, unlike in GASTROESOPHAGEAL REFLUX DISEASE. The symptoms are associated with IgE-mediated hypersensitivity to food or inhalant allergens.

A condition characterized by infiltration of the lung with EOSINOPHILS due to inflammation or other disease processes. Major eosinophilic lung diseases are the eosinophilic pneumonias caused by infections, allergens, or toxic agents.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

INFLAMMATION, acute or chronic, of the ESOPHAGUS caused by BACTERIA, chemicals, or TRAUMA.

INFLAMMATION of the ESOPHAGUS that is caused by the reflux of GASTRIC JUICE with contents of the STOMACH and DUODENUM.

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