A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).
Eligibility
Sex
ALL
Min age
12 Years
Max age
80 Years
Healthy volunteers
No
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 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 on 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 (for example 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.
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 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.
Primary outcome measure(s)
Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels — Week 24 Peak esophageal eosinophil count per HPF determined by histological analysis of 2-4 biopsies from each of the proximal, mid, and distal esophagus.
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score — Week 24 The Dysphagia Symptom Questionnaire (DSQ) captures the presence and severity of dysphagia symptoms in the past day in a 4-item questionnaire. The DSQ score is calculated over 14-day periods and ranges from 0 to 84, with a lower score indicating less severe dysphagia.
Trial sites (124)
Facility
City
Region
Status
Research Site
Phoenix
Arizona
Research Site
Little Rock
Arkansas
Research Site
Los Angeles
California
Research Site
Aurora
Colorado
Research Site
Inverness
Florida
Research Site
Jacksonville
Florida
Research Site
Saint Augustine
Florida
Research Site
Normal
Illinois
Research Site
Iowa City
Iowa
Research Site
Topeka
Kansas
Research Site
White Marsh
Maryland
Research Site
Boston
Massachusetts
Research Site
Chesterfield
Michigan
Research Site
Lincoln
Nebraska
Research Site
Ocean City
New Jersey
Research Site
Brooklyn
New York
Research Site
Chapel Hill
North Carolina
Research Site
Cincinnati
Ohio
Research Site
Philadelphia
Pennsylvania
Research Site
Uniontown
Pennsylvania
Research Site
Nashville
Tennessee
Research Site
Houston
Texas
Research Site
Salt Lake City
Utah
Research Site
Salt Lake City
Utah
Research Site
Elizabeth Vale
Australia
Research Site
Kogarah
Australia
Research Site
South Brisbane
Australia
Research Site
Woolloongabba
Australia
Research Site
Vienna
Austria
Research Site
Wels
Austria
Research Site
Bruges
Belgium
Research Site
Edegem
Belgium
Research Site
Ghent
Belgium
Research Site
Leuven
Belgium
Research Site
Botucatu
Brazil
Research Site
Brasília
Brazil
Research Site
Caxias do Sul
Brazil
Research Site
Curitiba
Brazil
Research Site
Curitiba
Brazil
Research Site
Porto Alegre
Brazil
+ 84 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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