Clinical study to investigate whether a single morning dose of 2 mg Budesonide (in the form of a melt tablet) is as effective and safe as taking two 1 mg Budesonide tablets, one in the morning and one in the evening, for the treatment of esophagitis.

ICTRP Trial ID
EUCTR2020-001314-37 (ICTRP)

Official title (approved by ethics committee)
Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis (BASEC)

Academic title
Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis (ICTRP)

Public title
clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus (ICTRP)

Disease under investigation
eosinophilic esophagitis
MedDRA version: 20.1Level: PTClassification code 10064212Term: Eosinophilic oesophagitisSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] (ICTRP)

Intervention under investigation

Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 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: 2-

Trade Name: Jorveza
Product Name: Budesonide 1 mg orodispersible tablets (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-
Pharmaceutical form of the placebo: Orodispersible tablet
Route of administration of the placebo: Oral use

(ICTRP)

Type of trial
Interventional clinical trial of medicinal product (ICTRP)

Trial design
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2 (ICTRP)

Inclusion/Exclusion criteria
Gender:
Female: yes
Male: yes

Inclusion criteria:
- Signed informed consent,
- Man or woman 18 to 75?years of age,
- Confirmed diagnosis of eosinophilic esophagitis (EoE)
- Active symptomatic and histological EoE
- At least 4?points in Patient?s Global Assessment (PatGA) concerning the severity of EoE symptoms at baseline visit,
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 196
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
(ICTRP)

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 gastro-intestinal 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 organic or psychiatric diseases/disorders, infectious diseases associated with clinical signs, liver cirrhosis, portal hypertension, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease
- History of cancer, 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. immunosuppressants, CYP3A4 inhibitors, live vaccination, non-stable treatment with proton pump inhibitors)
- exiting or intended pregnancy or breast-feeding


Primary and secondary end points
Main Objective: To prove the non-inferiority of 1?x?2?mg/d vs. 2?x?1?mg/d budesonide orodispersible tablets for the induction of histological remission in adult patients with active eosinophilic esophagitis (EoE);Secondary Objective: - To further assess EoE-associated clinical, endoscopic, and histological findings after 6?weeks treatment with budesonide orodispersible tablets,
- 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 with histological remission ;Timepoint(s) of evaluation of this end point: week 6 (ICTRP)

Secondary end point(s): 1. Change in the peak eos/mm2 hpf from baseline to week?6 (LOCF),

2. Change in the severity of dysphagia

3. Change in the severity of odynophagia

4. Change of overall severity of EoE symptoms

5. Change in the total weekly Eosinophilic Esophagitis Activity Index;Timepoint(s) of evaluation of this end point: week 6 (for secondary endpoints 1 - 5) (ICTRP)

Registration date
01.03.2021 (ICTRP)

Incorporation of the first participant
06.05.2021 (ICTRP)

Secondary sponsors
not available

Additional contacts
Dept. of Clinical R&D, sarah.burrack@drfalkpharma.de, +497611514193, Dr. Falk Pharma GmbH (ICTRP)

Secondary trial IDs
BUL-8/EEA, EOS-4, 2020-001314-37-DE (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001314-37 (ICTRP)