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Could one pill a day control this esophagus disease as well as two?

NCT ID NCT06596252

Disease control Sponsor: Dr. Falk Pharma GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tests if taking a budesonide tablet once daily works as well as taking it twice daily for adults with eosinophilic esophagitis, a condition where immune cells damage the esophagus. About 308 adults with active disease will receive one of the two dosing schedules for 6 weeks. The goal is to see if the simpler once-daily dose can achieve similar remission rates with fewer daily doses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 308 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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, * 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.

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Conditions

The condition(s) this trial relates to.

eosinophilic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic esophagitis

Contacts and locations

Locations

  • Department of Gastroenterology, Hospital General de Tomelloso

    Tomelloso, 13700, Spain

  • Dr. Falk Investigational Site

    Scottsdale, Arizona, 85259, United States

  • Dr. Falk Investigational Site

    Little Rock, Arkansas, 72205, United States

  • Dr. Falk Investigational Site

    La Jolla, California, 92037, United States

  • Dr. Falk Investigational Site

    San Diego, California, 92193, United States

  • Dr. Falk Investigational Site

    Doral, Florida, 83706, United States

  • Dr. Falk Investigational Site

    New Port Richey, Florida, 34653, United States

  • Dr. Falk Investigational Site

    Boise, Idaho, 83706, United States

  • Dr. Falk Investigational Site

    Boston, Massachusetts, 02111, United States

  • Dr. Falk Investigational Site

    Wyoming, Michigan, 49519, United States

  • Dr. Falk Investigational Site

    Rochester, Minnesota, 55905, United States

  • Dr. Falk Investigational Site

    Freehold, New Jersey, 07728, United States

  • Dr. Falk Investigational Site

    New York, New York, 10075, United States

  • Dr. Falk Investigational Site

    Chapel Hill, North Carolina, 27599-7080, United States

  • Dr. Falk Investigational Site

    Cleveland, Ohio, 44195, United States

  • Dr. Falk Investigational Site

    Mentor, Ohio, 44060, United States

  • Dr. Falk Investigational Site

    Harlingen, Texas, 78550, United States

  • Dr. Falk Investigational Site

    Salt Lake City, Utah, 85259, United States

  • Dr. Falk Investigational Site

    Lynchburg, Virginia, 24502, United States

  • Wyoming

    Ann Arbor, Michigan, 48109, United States

  • Wyoming

    Philadelphia, Pennsylvania, 19104, United States

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