A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission

• Register: EUCTR
• Last refreshed on: 7 January 2025
• Main ID: EUCTR2017-003516-39-ES
• Date of registration: 14/06/2021
• Prospective Registration: Yes
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission
• Scientific title: Double-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission
• Date of first enrolment: 22/07/2021
• Target sample size: 110
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003516-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Open-label: possible 6-week phases for induction or re-induction of remission If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Italy, Spain, Switzerland

Contacts

• Name: START UP UNIT
• Affiliation: SERMES PLANIFICACION S.L

• Name: START UP UNIT
• Affiliation: SERMES PLANIFICACION S.L

Key inclusion & exclusion criteria

Inclusion criteria:
• Signed informed consent,
• Male or female patients, 16 to 75 years of age,
• Confirmed clinico-histological diagnosis of EoE according to established diagnostic criteria,
• Clinico-histological remission of EoE,
• Negative pregnancy test in females of childbearing potential at baseline visit
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
• Gastroesophageal reflux disease (GERD),
• Achalasia, scleroderma esophagus, or systemic sclerosis,
• Clinically evident causes for esophageal eosinophilia other than EoE,
• Any concomitant esophageal disease and relevant active gastrointestinal disease,
• Abnormal laboratory values, presence of or suspected relevant concomitant disease(s), that could affect study-specific assessments and/or their evaluation, or might compromise patient's safety and/or compliance (e.g. severe cardiovascular, renal, endocrine, psychiatric diseases/disorders, relevant infectious diseases associated with clinical signs, liver cirrhosis, portal hypertension, or uncontrolled cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract,
• History of cancer, recent upper gastrointestinal bleeding, esophageal surgery, esophageal dilation procedures or need for an immediate endoscopic intervention due to a stricture
• Diagnosis of chickenpox, herpes zoster, or measles within the last 3 months prior to baseline,
• Treatment with medication, that could compromise/influence the effects of the study treatment, assessment of the endpoints and/or patients' safety, during or within too narrow timeframe of the clinical trial (e.g. systemic or oral glucocorticosteroids, immunosuppressants, CYP3A4 inhibitors, live vaccination, treatment with proton pump inhibitors, consumption of grapefruit)
• Existing or intended pregnancy or breast-feeding.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Jorveza 1 mg orodispersible tablets
Product Name: Budesonide 1 mg orodispersible tablets
Product Code: BUL 1 mg
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: Jorveza 0.5 mg orodispersible tablets
Product Name: Budesonide 0.5 mg orodispersible tablets
Product Code: BUL 0.5 mg
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Orodispersible tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Proportion of patients free of treatment failure after a 48 weeks DB treatment phase

Secondary Objective: Double-blind maintenance phase:
• To further assess EoE-associated clinical, endoscopic and histological findings after 48 weeks treatment for maintenance of remission,
• To study safety and tolerability as assessed by adverse events and laboratory parameters,
• To assess patients’ quality of life.

Main Objective: To prove superiority compared to placebo of episodic treatment with 4 cycles of budesonide 0.5 mg orodispersible tablets twice daily (BID) for 4 weeks followed by 8 weeks placebo BID over a total of 48 weeks and/or of continuous 48-week treatment with budesonide 0.5 mg orodispersible tablets BID in adult and adolescent eosinophilic esophagitis (EoE) patients in maintaining clinico-histological remission.

Timepoint(s) of evaluation of this end point: after 48 weeks of double-blind phase

Secondary Outcome(s)

Secondary end point(s): • Proportion of patients with histological relapse at DB week 48
• Proportion of patients with clinical relapse, or who have experienced a food impaction, which needed endoscopic intervention during the DB treatment phase
• Proportion of patients in clinico-histological remission at DB week 48

Timepoint(s) of evaluation of this end point: after 48 weeks of double-blind phase

Secondary ID(s)

2017-003516-39-DE

BUL-3/EER

Acronym

Source(s) of Monetary Support

Dr. Falk Pharma GmbH

Ethics review

Status: Approved
Approval date: 30/06/2021
Contact: