Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE)

NCT05214599 | Withdrawn Phase 2 DMC

• 1 other identifier: BAZ006-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (6)

• Determination of Pharmacokinetic Profiles

  Peak Plasma Concentration (Cmax)

  First 24 hours after a single drug dose administration

• Determination of Pharmacokinetic Profiles

  Area under the plasma concentration versus time curve (AUC)

  First 24 hours after a single drug dose administration

• Determination of Pharmacokinetic Profiles

  Half-life (T1/2)

  First 24 hours after a single drug dose administration

• Determination of Pharmacokinetic Profiles

  Oral clearance (CL/F)

  First 24 hours after a single drug dose administration

• Proportion of subjects reaching a histological response

  ≤ 6 eosinophils per high power field

  8 weeks of treatment

• Improvement in dysphagia symptoms consistent with the disease

  EAT (Eating Assessment Tool) -10 questionnaire

  8 weeks of treatment

Secondary Outcomes (2)

• Assessment of non-serious and serious adverse events rate

  Through 8 weeks

• Quality of life assessment of subjects

  Through 8 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

Low dose

Drug: Budesonide Gel

Group 2

EXPERIMENTAL

Middle dose

Drug: Budesonide Gel

Group 3

EXPERIMENTAL

High dose

Drug: Budesonide Gel

Interventions

Budesonide Gel DRUG

Twice daily regimen

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• Smoker of having quit smoking less than 6 months ago;
• Have a history of excessive alcohol intake for at least 6 months prior to trial start (intake of 5 or more alcoholic beverages in one day or 15 or more alcoholic beverages per week);
• Subjects having 5 or more cups of tea or coffee per day and who cannot abstain from them for the trial period;
• Be on CYP3A4 inhibitors, such as ketoconazole and grapefruit juice;
• Electrocardiogram (ECG) findings that, in the investigator's opinion, may jeopardize participation in the trial;

Sponsors & Collaborators

• Bazell Pharma AG: lead

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 28, 2022
• Study Start: April 23, 2021
• Primary Completion: November 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share