Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 January 2025 |
Main ID: |
EUCTR2017-003516-39-ES |
Date of registration:
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14/06/2021 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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22/07/2021 |
Target sample size:
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110 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003516-39 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Italy
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Spain
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Switzerland
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Contacts
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Name:
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START UP UNIT
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Address:
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Calle Rufino González, 14-2º D
28037
Madrid
Spain |
Telephone:
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+3491327 50 25 |
Email:
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start-up@sermescro.com |
Affiliation:
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SERMES PLANIFICACION S.L |
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Name:
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START UP UNIT
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Address:
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Calle Rufino González, 14-2º D
28037
Madrid
Spain |
Telephone:
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+3491327 50 25 |
Email:
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start-up@sermescro.com |
Affiliation:
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SERMES PLANIFICACION S.L |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1
Level: LLT
Classification code 10064220
Term: Eosinophilic esophagitis
System Organ Class: 100000004856
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Intervention(s)
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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
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Primary Outcome(s)
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Primary end point(s): Proportion of patients free of treatment failure after a 48 weeks DB treatment phase
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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.
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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.
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Timepoint(s) of evaluation of this end point: after 48 weeks of double-blind phase
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: after 48 weeks of double-blind phase
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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
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Secondary ID(s)
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Acronym
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2017-003516-39-DE
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BUL-3/EER
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Source(s) of Monetary Support
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Dr. Falk Pharma GmbH
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Ethics review
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Status: Approved
Approval date: 30/06/2021
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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