A study to investigate changes in symptoms and esophageal histology withtezepelumab compared with placebo in patients aged 12 to 80 years oldwith eosinophilic esophagitis

Phase 1

• Conditions: Eosinophilic esophagitis (EoE) is a rare, chronic inflammatory disorder triggered by an immune response to foods and aeroantigens and characterized by a combination of esophageal dysfunction and eosinophilic infiltration of the esophagus; MedDRA version: 20.1Level: LLTClassification code 10064220Term: Eosinophilic esophagitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2022-001294-31-FI
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-05
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.

2. Weight = 40 kg at Visit 1

3. Established diagnosis of EoE with a previous EGD and esophageal
biopsy confirming a diagnosis of EoE.

4. Participants who have symptomatic EoE as defined by a history of on
average at least 2 episodes of dysphagia (any severity of food going
down slowly or being stuck in the throat) per week in the 4 weeks prior
to Visit 1.

5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1
and during the course of the study (stable diet is defined as no initiation
of single or multiple elimination diets or reintroduction of previously
eliminated food groups).

6. May be on any background medication for EoE, for example PPI
and/or STC, during the course of the study, as long as background
medications have been stable for at least 8 weeks prior to the
screening/run-in period (Visit 1) and there is agreement not to change
background medication or dosage unless medically indicated, during the
screening/run-in and treatment period.

7. Participants currently leukotriene inhibitors and/or steroid treatments
for asthma or allergies that are inhaled or administered intranasally,
must report a stable dose for at least 4 weeks prior to the
screening/run-in period (Visit 1).

8. If a medication for EoE (including PPI and/or STC) is discontinued
prior to the screening/run-in, there should be a washout period of at
least 8 weeks prior to Visit 1. Discontinuation of any marketed biologic
(monoclonal or polyclonal antibody) should have a washout period of 4
months or 5 half-lives prior to Visit 1, whichever is longer.

9. Participants should have previously documented standard of care
treatment, which could include PPI and/or STC and/or diet
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 314
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion.
2.Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
3. Use of a feeding tube, or having a pattern of not eating solid food = 3 days of the week. Solid food is defined as food that requires chewing before swallowing.
4. Hypereosinophilic syndrome.
5. EGPA vasculitis
6. Esophageal dilation performed within 8 weeks prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified