CEGIR 7808: Use of Unsedated Transnasal Esophagoscopy (TNE) to Monitor Dietary Management of Eosinophilic...
Eosinophilic EsophagitisThe purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy as a means of monitoring Eosinophilic Esophagitis patients.
Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)...
Eosinophilic EsophagitisEosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE. APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.
Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux...
Erosive EsophagitisA randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).
Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis...
Erosive Esophagitis (EE)This is a multi-center, randomized, double-blind, parallel-group, active controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50 mg comparing with esomeprazole 40 mg after the treatment of erosive esophagitis in Chinese patients for up to 8 weeks. Screening-eligible subjects will be randomized into LXI-15028 50mg treatment group or esomeprazole 40mg treatment group at Visit 2 (Day 0) stratified by LA grade (A or B/C/D) at baseline according to the ratio of 1:1 and receive study treatment continuously for 4 or 8 weeks. They will start to take the investigational products from the following morning (Day 1) of Visit 2, and start to complete the subject's diary from the day of study treatment initiation. After 4 weeks of study treatment (treatment period 1), subjects will return to the study site and complete Visit 3. For the subjects who achieve endoscopic healing at Visit 3, the study treatment will be terminated. The subjects who fail to achieve endoscopic healing at Visit 3 will receive newly dispensed investigational product after completing the fasting examinations at Visit 3, and continue another 4 weeks of study treatment (treatment period 2) and complete Visit 4. All the subjects will be followed up by phone (Visit 5) at Day 28±3 after the last dose of investigational products.
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic...
Eosinophilic EsophagitisThe purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.
SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects...
Eosinophilic Esophagitis (EoE)The principal aim of this study is to obtain safety and tolerability data when AQ280 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.
A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic...
Eosinophilic EsophagitisThe purpose of this study is to asses the efficacy, safety and tolerability of repeat doses of IRL201104 in Adult Participants with Active Eosinophilic Esophagitis (EoE)
Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis...
Erosive EsophagitisThe purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8.
To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis
EsophagitisRefluxThe purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide...
Eosinophilic Esophagitis (EoE)This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire (DSQ) score.