Eosinophilic EsophagitisPhase 3EOS-4NCT06596252
Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
A Phase 3 study testing Budesonide in people with Eosinophilic Esophagitis, run by Dr. Falk Pharma GmbH at 21 sites in 2 countries.
Trial summary
The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 21 May 2021to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Signed informed consent,
- Male or female patients, 18 to 75 years of age,
- Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
- Active symptomatic and histological EoE
- Negative pregnancy test in females of childbearing potential at baseline visit.
Who cannot join
- Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
- Achalasia, scleroderma esophagus, or systemic sclerosis,
- Other clinically evident causes than EoE for esophageal eosinophilia,
- Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection [candida esophagitis]),
- Any relevant systemic disease (e.g., AIDS, active tuberculosis, hepatitis B or C),
- If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
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- Liver cirrhosis or portal hypertension,
- History of cancer in the last five years,
- History of esophageal surgery at any time or of esophageal dilation procedures within the last 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture
- Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,
- Existing or intended pregnancy or breast-feeding.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Wyoming
Ann Arbor, Michigan, 48109
Dr. Falk Investigational Site
Boise, Idaho, 83706
Dr. Falk Investigational Site
Boston, Massachusetts, 02111
Dr. Falk Investigational Site
Chapel Hill, North Carolina, 27599-7080
Dr. Falk Investigational Site
Cleveland, Ohio, 44195
Dr. Falk Investigational Site
Doral, Florida, 83706
Dr. Falk Investigational Site
Freehold, New Jersey, 07728
Dr. Falk Investigational Site
Harlingen, Texas, 78550
Dr. Falk Investigational Site
La Jolla, California, 92037
Dr. Falk Investigational Site
Little Rock, Arkansas, 72205
Dr. Falk Investigational Site
Lynchburg, Virginia, 24502
Dr. Falk Investigational Site
Mentor, Ohio, 44060
Dr. Falk Investigational Site
New Port Richey, Florida, 34653
Dr. Falk Investigational Site
New York, New York, 10075
Wyoming
Philadelphia, Pennsylvania, 19104
Dr. Falk Investigational Site
Rochester, Minnesota, 55905
Dr. Falk Investigational Site
Salt Lake City, Utah, 85259
Dr. Falk Investigational Site
San Diego, California, 92193
Dr. Falk Investigational Site
Scottsdale, Arizona, 85259
Dr. Falk Investigational Site
Wyoming, Michigan, 49519
Spain1 site
Department of Gastroenterology, Hospital General de Tomelloso
Tomelloso, 13700
About this study
Official title: Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis
The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Budesonide
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Twice daily intake of the tablet 30 min after a meal
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Budesonide 2 mg orodispersible tablet once daily Receives: Drug: Budesonide |
| Arm B | Active comparator | Budesonide 1 mg orodispersible tablet twice daily Receives: Drug: Budesonide |
| OLE | Experimental | Open label extension with Budesonide 0.5 mg or 1 mg orodispersible tablet twice daily Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in histological remission
Histological assessment of biopsies taken at end of treatment visit
Measured: 6 weeks
Secondary outcomes (1)
Proportion of patients in clinical remission
Assessment of clinical scores assessed with questionnaires at the end of treatment visit
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 May 2021
- Primary completionDec 2026 (estimated)
- Study completionMar 2028 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Double-blind, controlled interventional study phase followed by an optional open-label extension phase
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfredo J Lucendo, MD, PhD, Study director, Department of Gastroenterology, Hospital General de Tomelloso, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596252
- Sponsor's protocol ID
- BUL-8/EEA
- Other IDs
- 2024-515229-26-00, 2020-001314-37
- Acronym
- EOS-4
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is not yet decided which data will be made available. Neither a time frame can be indicated yet.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT06596252
- Acronym / sponsor ID
- EOS-4 / BUL-8/EEA
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, controlled interventional study phase followed by an optional open-label extension phase
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BudesonideBudesonide 2 mg orodispersible tablet once daily |
| Arm B | Active comparator | Drug: BudesonideBudesonide 1 mg orodispersible tablet twice daily |
| OLE | Experimental | Drug: BudesonideOpen label extension with Budesonide 0.5 mg or 1 mg orodispersible tablet twice daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent,
- Male or female patients, 18 to 75 years of age,
- Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
- Active symptomatic and histological EoE
- Negative pregnancy test in females of childbearing potential at baseline visit.
Key exclusion criteria (11 listed)
- Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
- Achalasia, scleroderma esophagus, or systemic sclerosis,
- Other clinically evident causes than EoE for esophageal eosinophilia,
- Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection [candida esophagitis]),
- Any relevant systemic disease (e.g., AIDS, active tuberculosis, hepatitis B or C),
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 |
|---|---|---|
| BudesonideTwice daily intake of the tablet 30 min after a meal | Drug | Arm A, Arm B, OLE |
Primary outcome
Proportion of patients in histological remission
Time frame: 6 weeks
Histological assessment of biopsies taken at end of treatment visit
1 secondary outcome
Proportion of patients in clinical remission
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. It is not yet decided which data will be made available. Neither a time frame can be indicated yet.
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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.
Alfredo J Lucendo, MD, PhD study director
Department of Gastroenterology, Hospital General de Tomelloso, Spain
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide in people with Eosinophilic Esophagitis, run by Dr. Falk Pharma GmbH at 21 sites in 2 countries.
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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of patients in histological remission (time frame: 6 weeks). 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 28 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.