Clinical trial • Phase III • Gastroenterology|Rare Disease

Budesonide for Eosinophilic oesophagitis

Phase III trial of Budesonide for Eosinophilic oesophagitis.

Overview

Trial Therapeutic Area
Gastroenterology|Rare Disease
Trial Disease
Eosinophilic oesophagitis
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
24-07-2024
First CTIS Authorization Date
19-08-2024

Trial design

Randomised, jorveza 1 mg orodispersible tablets (budesonide) — 1 mg twice daily; orodispersible tablet placebo (double-dummy matching placebo)-controlled Phase III trial in Austria, Portugal, Germany and others.

Randomised
Yes
Comparator
Jorveza 1 mg orodispersible tablets (budesonide) — 1 mg twice daily; Orodispersible tablet placebo (double-dummy matching placebo)
Target Sample Size
74
Trial Duration For Participant
42

Eligibility

Recruits 74 Vulnerable population not selected. Trial enrols adults only (inclusion: "Man or woman 18 to 75 years of age"). Signed informed consent from the participant is required; no assent procedures described..

Pregnancy Exclusion
Exiting or intended pregnancy or breast-feeding
Vulnerable Population
Vulnerable population not selected. Trial enrols adults only (inclusion: "Man or woman 18 to 75 years of age"). Signed informed consent from the participant is required; no assent procedures described.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent\n- Man or woman 18 to 75 years of age\n- Confirmed diagnosis of eosinophilic esophagitis (EoE)\n- Active symptomatic and histological EoE\n- At least 4 points in Patient's Global Assessment (PatGA) concerning the severity of EoE symptoms at baseline visit"}

Exclusion criteria

  • {"criterion_text":"- Gastroesophageal reflux disease (GERD)\n- Achalasia, scleroderma esophagus, or systemic sclerosis\n- Clinically evident causes for esophageal eosinophilia other than EoE\n- Any concomitant esophageal disease and relevant active gastrointestinal disease\n- 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\n- History of cancer, gastrointestinal bleeding, esophageal surgery, esophageal dilation procedures or need for an immediate endoscopic intervention due to a stricture\n- Diagnosis of chickenpox, herpes zoster, or measles within the last 3 months prior to baseline\n- 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)\n- Exiting or intended pregnancy or breast-feeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of patients with histological remission","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Change in the peak eos/mm2 hpf from baseline to week 6 (LOCF)","definition_or_measurement_approach":"Change from baseline to week 6; analysis uses LOCF (last observation carried forward) as indicated"}
  • {"endpoint_text":"- Change in the severity of dysphagia","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in the severity of odynophagia","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change of overall severity of EoE symptoms","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in the total weekly Eosinophilic Esophagitis Activity Index","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
74
Recruitment Window Months
54
Consent Approach
Signed informed consent is required from each participant (adult participants). Subject information and informed consent form documents are provided and redacted versions exist for multiple countries. ICFs available in country-specific versions: German (GER/AUT), Portuguese (PRT), Spanish (ESP) (documents present for AUT, PRT, GER, ESP). Pregnancy/newborn ICF versions are also provided.

Methods

  • Poster — recruitment material documents present (PosterWording / PosterDesign) (country-specific documents listed for Austria, Portugal, Germany, Spain)
  • Flyer — recruitment material documents present (FlyerWording / FlyerDesign) (country-specific documents listed for Austria, Portugal, Germany, Spain)
  • Website text — 'WebsideWording' / 'HomepageText' documents present
  • Referral letter — 'ReferralLetter' recruitment material document present
  • SEA — recruitment material labelled 'SEA' present (document listed)

Geography

Total Number Of Sites
23
Total Number Of Participants
234

Austria

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
15-09-2024
Processing Time Days
37
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Innere 2, Gastroenterologie
Contact Person Name
Andreas Maieron
Contact Person Email
Interne2@stpoelten.lknoe.at
Site Name
Medical University Of Graz
Department Name
Klinische Abteilung für Gastroenterologie und Hepatologie
Contact Person Name
Andreas Blesl
Contact Person Email
andreas.posch@medunigraz.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Internal medicine IV
Contact Person Name
Michael Weitersberger

Portugal

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
28-08-2024
Processing Time Days
19
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Lusiadas S.A.
Department Name
Gastroenterology
Contact Person Name
David Serra
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Serviço de Gastrenterologia
Contact Person Name
Lídia Roque Ramos
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Serviço de Gastrenterologia / Gastroenterology Department
Contact Person Name
Guilherme Macedo

Germany

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
10
Number Of Sites
8
Number Of Participants
48

Sites

Site Name
Sana Kliniken Berlin-Brandenburg GmbH
Department Name
Innere 1, Gastroenterologie
Contact Person Name
Christoph Schmoecker
Contact Person Email
Christoph.Schmoecker@Sana.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Gastroenterologie
Contact Person Name
Simon Weidlich
Site Name
Centrum Gastroenterologie Bethanien
Department Name
Gastroenterologie
Contact Person Name
Mate Knabe
Site Name
Universitaet Leipzig
Department Name
Gastroenterologie
Contact Person Name
Charlotte Ackmann
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Gastroenterologie
Contact Person Name
Ulrike von Arnim
Contact Person Email
catrin.anders@med.ovgu.de
Site Name
Universitaetsklinikum Brandenburg an der Havel GmbH
Department Name
Gastroenterologie
Contact Person Name
Stefan Lüth
Contact Person Email
mandy.voortmann@mhb-fontane.de
Site Name
Universitaetsklinikum Augsburg
Department Name
University Hospital Augsburg III. med. Clinic
Contact Person Name
Sandra Nagl
Contact Person Email
studien-3.med@uk-augsburg.de
Site Name
Facharztzentrum Eppendorf
Department Name
Magen-Darm-Zentrum
Contact Person Name
Stephan Miehlke
Contact Person Email
info@faz-eppendorf.de

Spain

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
29-08-2024
Processing Time Days
21
Number Of Sites
9
Number Of Participants
160

Sites

Site Name
Hospital General De Tomelloso
Department Name
Department of Gastroenterology
Contact Person Name
Alfredo Lucendo
Contact Person Email
ajlucendo@sescam.jccm.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Digestive. Gastroenterology. Endoscopy.
Contact Person Name
Leonardo Blas Jhon
Contact Person Email
LBLASJH@fjd.es
Site Name
Hospital Universitario Miguel Servet
Department Name
Digestive Department
Contact Person Name
Javier Alcedo González
Site Name
Hospital Universitario Central De Asturias
Department Name
Gastroenterology
Contact Person Name
Isabel Perez Martinez
Contact Person Email
isabel.perezm@sespa.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Gastroenterology Department
Contact Person Name
Danila Guagnozzi
Contact Person Email
web@vallhebron.cat
Site Name
Hospital Universitario Rio Hortega
Department Name
Digestive
Contact Person Name
Jesus Barrio
Contact Person Email
rconvi@saludcastillayleon.es
Site Name
Hospital Universitario De Fuenlabrada
Department Name
Gastroenterology
Contact Person Name
Alicia Granja Navacerrada
Contact Person Email
Alicia.granja@salud.madrid.org
Site Name
Hospital Universitario De La Princesa
Department Name
Gastroenterology and Hepatology Department
Contact Person Name
Cecilio Santander Vaquero
Contact Person Email
digeeo.hlpr@salud.madrid.org
Site Name
Hospital De Viladecans
Department Name
Hospital Gastroenterology
Contact Person Name
Luisa de la Peña
Contact Person Email
luisacp@bellvitgehospital.cat

Sponsor

Primary sponsor

Full Name
Dr. Falk Pharma GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
X-act Cologne Clinical Research GmbH
Responsibilities
codes:10,15 (15: IWRS - treatment randomisation),6,7
Name
QbD Clinical
Responsibilities
codes:1,12
Name
Med IVD Healthtech S.L.
Responsibilities
codes:1,12
Name
Symbio Clinical Research GmbH
Responsibilities
codes:1,11,12,13,2,5,8

Third parties

  • {"country":"Germany","full_name":"NextPharma GmbH","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Med IVD Healthtech S.L.","duties_or_roles":"codes:1,12","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Labor Dr. Spranger","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"QbD Clinical","duties_or_roles":"codes:1,12","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"ACC GmbH Analytical Clinical Concepts","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Klinikum Bayreuth GmbH","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"X-act Cologne Clinical Research GmbH","duties_or_roles":"codes:10,15 (15: IWRS - treatment randomisation),6,7","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Symbio Clinical Research GmbH","duties_or_roles":"codes:1,11,12,13,2,5,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BUL03
Active Substance
Budesonide
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Investigational (no marketing authorisation indicated in record)
Orphan Designation
Yes
Starting Dose
2 mg once daily
Dose Levels
2 mg once daily
Frequency
Once daily
Maximum Dose
2 mg daily
Investigational Product Name
Jorveza 1 mg orodispersible tablets
Active Substance
Budesonide
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation EU/1/17/1254/001)
Orphan Designation
Yes
Starting Dose
1 mg twice daily
Dose Levels
1 mg twice daily
Frequency
Twice daily
Maximum Dose
2 mg daily
Investigational Product Name
Orodispersible tablet (placebo)
Modality
Other
Authorisation Status
Not applicable (placebo)

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