Eosinophilic EsophagitisPhase 2BESIDENCT05214599
Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE)
A Phase 2 study testing Budesonide Gel in people with Eosinophilic Esophagitis, run by Bazell Pharma AG.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Budesonide Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2021to Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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.
About this study
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)
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
- Being tested
- Budesonide Gel
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide GelDrug
Twice daily regimen
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Low dose Receives: Drug: Budesonide Gel |
| Group 2 | Experimental | Middle dose Receives: Drug: Budesonide Gel |
| Group 3 | Experimental | High dose Receives: Drug: Budesonide Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Pharmacokinetic Profiles
Peak Plasma Concentration (Cmax)
Measured: First 24 hours after a single drug dose administration
Determination of Pharmacokinetic Profiles
Area under the plasma concentration versus time curve (AUC)
Measured: First 24 hours after a single drug dose administration
Determination of Pharmacokinetic Profiles
Half-life (T1/2)
Measured: First 24 hours after a single drug dose administration
Determination of Pharmacokinetic Profiles
Oral clearance (CL/F)
Measured: First 24 hours after a single drug dose administration
Proportion of subjects reaching a histological response
≤ 6 eosinophils per high power field
Measured: 8 weeks of treatment
Improvement in dysphagia symptoms consistent with the disease
EAT (Eating Assessment Tool) -10 questionnaire
Measured: 8 weeks of treatment
Secondary outcomes (2)
Assessment of non-serious and serious adverse events rate
Measured: Through 8 weeks
Quality of life assessment of subjects
WHOQOL-bref questionnaire
Measured: Through 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start23 Apr 2021
- Primary completionNov 2024 (estimated)
- Study completionApr 2025 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bazell Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214599
- Sponsor's protocol ID
- BAZ006-001
- Acronym
- BESIDE
- Status last verified
- Aug 2024
- First submitted
- 3 Jan 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05214599
- Acronym / sponsor ID
- BESIDE / BAZ006-001
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bazell Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Budesonide GelLow dose |
| Group 2 | Experimental | Drug: Budesonide GelMiddle dose |
| Group 3 | Experimental | Drug: Budesonide GelHigh dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide GelTwice daily regimen | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Determination of Pharmacokinetic Profiles
Time frame: First 24 hours after a single drug dose administration
Peak Plasma Concentration (Cmax)
Determination of Pharmacokinetic Profiles
Time frame: First 24 hours after a single drug dose administration
Area under the plasma concentration versus time curve (AUC)
Determination of Pharmacokinetic Profiles
Time frame: First 24 hours after a single drug dose administration
Half-life (T1/2)
Determination of Pharmacokinetic Profiles
Time frame: First 24 hours after a single drug dose administration
Oral clearance (CL/F)
Proportion of subjects reaching a histological response
Time frame: 8 weeks of treatment
≤ 6 eosinophils per high power field
Improvement in dysphagia symptoms consistent with the disease
Time frame: 8 weeks of treatment
EAT (Eating Assessment Tool) -10 questionnaire
2 secondary outcomes
Assessment of non-serious and serious adverse events rate
Time frame: Through 8 weeks
Quality of life assessment of subjects
Time frame: Through 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide Gel in people with Eosinophilic Esophagitis, run by Bazell Pharma AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Pharmacokinetic Profiles (time frame: First 24 hours after a single drug dose administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.