Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE) (BESIDE)
Primary Purpose
Eosinophilic Esophagitis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Budesonide Gel
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis
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;
- 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;
- History or presence of gastrointestinal or liver disease or other condition interfering with drug absorption, distribution, excretion or metabolism;
- Subjects with hypersensitivity or contraindication of using any formulation components;
- Subjects who have been part of trial protocols in the last 12 (twelve) months (CNS Resolution 251, dated August 7, 1997, item III, sub-item J);
- Have donated blood (> 500 mL) or undergone major surgery within the 3 months prior to the ICF signature date;
- Have been vaccinated for the 30 days prior to admission;
- Clinical evidence of infectious process potentially contributing for dysphagia (candidiasis, cytomegalovirus (CMV), herpes);
- Other dysphagia cause identified at endoscopy (peptic stenosis, web, ring, achalasia, esophageal neoplasm);
- Breastfeeding subjects, who plan to become pregnant or with a positive pregnancy test during the trial;
- Any medical condition or laboratory change that, in the investigator's opinion, may jeopardize participation in the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Low dose
Middle dose
High dose
Outcomes
Primary Outcome Measures
Determination of Pharmacokinetic Profiles
Peak Plasma Concentration (Cmax)
Determination of Pharmacokinetic Profiles
Area under the plasma concentration versus time curve (AUC)
Determination of Pharmacokinetic Profiles
Half-life (T1/2)
Determination of Pharmacokinetic Profiles
Oral clearance (CL/F)
Proportion of subjects reaching a histological response
≤ 6 eosinophils per high power field
Improvement in dysphagia symptoms consistent with the disease
EAT (Eating Assessment Tool) -10 questionnaire
Secondary Outcome Measures
Assessment of non-serious and serious adverse events rate
Quality of life assessment of subjects
WHOQOL-bref questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05214599
Brief Title
Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE)
Acronym
BESIDE
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 31, 2024 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bazell Pharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Low dose
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Middle dose
Arm Title
Group 3
Arm Type
Experimental
Arm Description
High dose
Intervention Type
Drug
Intervention Name(s)
Budesonide Gel
Intervention Description
Twice daily regimen
Primary Outcome Measure Information:
Title
Determination of Pharmacokinetic Profiles
Description
Peak Plasma Concentration (Cmax)
Time Frame
First 24 hours after a single drug dose administration
Title
Determination of Pharmacokinetic Profiles
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
First 24 hours after a single drug dose administration
Title
Determination of Pharmacokinetic Profiles
Description
Half-life (T1/2)
Time Frame
First 24 hours after a single drug dose administration
Title
Determination of Pharmacokinetic Profiles
Description
Oral clearance (CL/F)
Time Frame
First 24 hours after a single drug dose administration
Title
Proportion of subjects reaching a histological response
Description
≤ 6 eosinophils per high power field
Time Frame
8 weeks of treatment
Title
Improvement in dysphagia symptoms consistent with the disease
Description
EAT (Eating Assessment Tool) -10 questionnaire
Time Frame
8 weeks of treatment
Secondary Outcome Measure Information:
Title
Assessment of non-serious and serious adverse events rate
Time Frame
Through 8 weeks
Title
Quality of life assessment of subjects
Description
WHOQOL-bref questionnaire
Time Frame
Through 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
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;
History or presence of gastrointestinal or liver disease or other condition interfering with drug absorption, distribution, excretion or metabolism;
Subjects with hypersensitivity or contraindication of using any formulation components;
Subjects who have been part of trial protocols in the last 12 (twelve) months (CNS Resolution 251, dated August 7, 1997, item III, sub-item J);
Have donated blood (> 500 mL) or undergone major surgery within the 3 months prior to the ICF signature date;
Have been vaccinated for the 30 days prior to admission;
Clinical evidence of infectious process potentially contributing for dysphagia (candidiasis, cytomegalovirus (CMV), herpes);
Other dysphagia cause identified at endoscopy (peptic stenosis, web, ring, achalasia, esophageal neoplasm);
Breastfeeding subjects, who plan to become pregnant or with a positive pregnancy test during the trial;
Any medical condition or laboratory change that, in the investigator's opinion, may jeopardize participation in the trial.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make individual participant data (IPD) available
Learn more about this trial
Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE)
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