Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 100000004856
Conditions
Interventions
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
C
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;Primary end point(s): Proportion of patients free of treatment failure after a 48 weeks DB treatment phase;Timepoint(s) of evaluation of this end point: after 48 weeks of double-blind phase | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany, Italy, Spain, Switzerland
Contacts
Public ContactDept. of Clinic. Res. & Development
Dr. Falk Pharma GmbH
Outcome results
None listed