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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
Bazell Pharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 3, 2022
    Last Updated
    September 25, 2023
    Sponsor
    Bazell Pharma AG
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    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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