A Phase I/II, Multicenter, Double-blind, Parallel, Randomized Trial to Assess Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults Subjects of Both Genders With Eosinophilic Esophagitis (EoE)

Bazell Pharma AG0 sitesApril 23, 2021

ConditionsEosinophilic Esophagitis

InterventionsBudesonide Gel

DrugsBudesonide Gel

Overview

Phase: Phase 2
Intervention: Budesonide Gel
Conditions: Eosinophilic Esophagitis
Sponsor: Bazell Pharma AG
Primary Endpoint: Improvement in dysphagia symptoms consistent with the disease
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A phase I/II, multicenter, double-blind, parallel, randomized trial to assess pharmacokinetics, efficacy, tolerability and safety of different budesonide oral gel doses in adults subjects of both genders with eosinophilic esophagitis (EoE)

Registry

clinicaltrials.gov

Start Date

April 23, 2021

End Date

April 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bazell Pharma AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects able to read, understand and sign the Informed Consent Form (ICF) approved by Ethical Committee;
•Male and female subjects aged between 18 and 75 years old;
•Body weight between 60-100 kg;
•Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2;
•Non-childbearing potential female subjects. Childbearing potential is defined as: post-menopausal women (defined as 12 months of amenorrhea or more), hysterectomized women, oophorectomized (bilateral) women and/or those who underwent tubal ligation;
•Female participants of childbearing potential who test negative for the pregnancy test on the day of administration of the first dose of the drug (Visit 1), as well as throughout the clinical trial;
•Female participants who practice adequate contraception or who abstain from all activities that could result in pregnancy for at least 28 days before administering the first dose of the drug (Visit 1);
•Female participants who agree to continue adequate contraception for 1 month after administration of the last dose of the investigational drug;
•Participants diagnosed with EoE, verified from a combination of symptoms compatible with EoE and histological finding greater than 15 eosinophils per high-power field in at least one esophageal mucosal biopsy;
•Participants unresponsive to stable dose of proton-pump inhibitor (PPI).

Exclusion Criteria

•Subjects with a malignancy history within the last 5 years, except from successfully treated basal cell carcinoma;
•History of esophageal stenosis requiring dilation and/or stenosis at endoscopy not allowing to pass the endoscope;
•Subjects with a eosinophilic gastroenteritis diagnosis (presence of eosinophilic infiltrate in gastric antrum and duodenum);
•Subjects with a reflux esophagitis history;
•Subject with a previous serious asthma diagnosis;
•Subjects with a gastroesophageal tract disease that, at the investigator's discretion, is deemed as an obstacle to take part in the trial;
•People with chronic diseases on regular drugs that, in the investigator's opinion, may interfere with the trial;
•Medical conditions such as serious heart or lung diseases preventing the safe performance of endoscopy;
•Subjects with conditions known to be related to esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia and hypereosinophilic syndrome;
•Subjects who have been on oral, intranasal or systemic corticosteroid at least 15 days prior to trial start;