NCT06596252

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P50-P75 for phase_3

Timeline
10mo left

Started May 2021

Longer than P75 for phase_3

Geographic Reach
2 countries

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
May 2021Mar 2027

Study Start

First participant enrolled

May 21, 2021

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 27, 2026

Status Verified

March 1, 2026

Enrollment Period

5.5 years

First QC Date

September 11, 2024

Last Update Submit

April 22, 2026

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients in histological remission

    Histological assessment of biopsies taken at end of treatment visit

    6 weeks

Secondary Outcomes (1)

  • Proportion of patients in clinical remission

    6 weeks

Study Arms (3)

Arm A

EXPERIMENTAL

Budesonide 2 mg orodispersible tablet once daily

Drug: Budesonide

Arm B

ACTIVE COMPARATOR

Budesonide 1 mg orodispersible tablet twice daily

Drug: Budesonide

OLE

EXPERIMENTAL

Open label extension with Budesonide 0.5 mg or 1 mg orodispersible tablet twice daily

Drug: Budesonide

Interventions

BudesonideDRUG

Twice daily intake of the tablet 30 min after a meal

Arm AArm BOLE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Dr. Falk Investigational Site

Scottsdale, Arizona, 85259, United States

NOT YET RECRUITING

Dr. Falk Investigational Site

Little Rock, Arkansas, 72205, United States

RECRUITING

Dr. Falk Investigational Site

La Jolla, California, 92037, United States

RECRUITING

Dr. Falk Investigational Site

Lomita, California, 90717, United States

WITHDRAWN

Dr. Falk Investigational Site

San Diego, California, 92193, United States

NOT YET RECRUITING

Dr. Falk Investigational Site

Doral, Florida, 83706, United States

RECRUITING

Dr. Falk Investigational Site

New Port Richey, Florida, 34653, United States

RECRUITING

Dr. Falk Investigational Site

Boise, Idaho, 83706, United States

RECRUITING

Dr. Falk Investigational Site

Houma, Louisiana, 70363, United States

RECRUITING

Dr. Falk Investigational Site

Marrero, Louisiana, 70072, United States

RECRUITING

Dr. Falk Investigational Site

Boston, Massachusetts, 02111, United States

RECRUITING

Wyoming

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Dr. Falk Investigational Site

Wyoming, Michigan, 49519, United States

RECRUITING

Dr. Falk Investigational Site

Rochester, Minnesota, 55905, United States

RECRUITING

Dr. Falk Investigational Site

Freehold, New Jersey, 07728, United States

RECRUITING

Dr. Falk Investigational Site

Jackson, New Jersey, 08527, United States

RECRUITING

Dr. Falk Investigational Site

New York, New York, 10075, United States

RECRUITING

Dr. Falk Investigational Site

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

RECRUITING

Dr. Falk Investigational Site

Cleveland, Ohio, 44195, United States

RECRUITING

Dr. Falk Investigational Site

Mentor, Ohio, 44060, United States

NOT YET RECRUITING

Wyoming

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Dr. Falk Investigational Site

Harlingen, Texas, 78550, United States

RECRUITING

Dr. Falk Investigational Site

Salt Lake City, Utah, 85259, United States

RECRUITING

Dr. Falk Investigational Site

Charlottesville, Virginia, 22903, United States

NOT YET RECRUITING

Dr. Falk Investigational Site

Lynchburg, Virginia, 24502, United States

NOT YET RECRUITING

Department of Gastroenterology, Hospital General de Tomelloso

Tomelloso, 13700, Spain

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Budesonide

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Alfredo J Lucendo, MD, PhD

    Department of Gastroenterology, Hospital General de Tomelloso, Spain

    STUDY DIRECTOR

Central Study Contacts

Sarah Burrack, Dr.

CONTACT

004976115140zentrale@drfalkpharma.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Double-blind, controlled interventional study phase followed by an optional open-label extension phase
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

May 21, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

April 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

It is not yet decided which data will be made available. Neither a time frame can be indicated yet.

Time Frame
It is not yet decided which data will be made available. Neither a time frame can be indicated yet.
Access Criteria
Contact to Dr. Falk, issue of confidentiality agreement for any information not publicly available.

Locations

US(25)ES(1)