New shot could ease swallowing trouble for thousands

NCT ID NCT05583227

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests an experimental drug called tezepelumab in people aged 12 to 80 with eosinophilic esophagitis, a condition where white blood cells build up in the esophagus, causing trouble swallowing. Participants receive either the drug or a placebo as a shot under the skin. The goal is to see if the drug reduces inflammation and improves swallowing symptoms.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

368 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

eosinophilic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic esophagitis

Contacts and locations

Locations

Research Site

Phoenix, Arizona, 85016, United States
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Little Rock, Arkansas, 72202, United States
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Los Angeles, California, 90033, United States
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Aurora, Colorado, 80045, United States
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Inverness, Florida, 34452, United States
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Jacksonville, Florida, 32256, United States
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Saint Augustine, Florida, 32086, United States
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Normal, Illinois, 61761, United States
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Iowa City, Iowa, 52242, United States
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Topeka, Kansas, 66606, United States
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White Marsh, Maryland, 21162, United States
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Boston, Massachusetts, 02111, United States
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Chesterfield, Michigan, 48047, United States
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Lincoln, Nebraska, 68503, United States
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Ocean City, New Jersey, 07712, United States
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Brooklyn, New York, 11235, United States
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Chapel Hill, North Carolina, 27599, United States
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Cincinnati, Ohio, 45229, United States
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Philadelphia, Pennsylvania, 19104, United States
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Uniontown, Pennsylvania, 15401, United States
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Nashville, Tennessee, 37232, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84107, United States
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Salt Lake City, Utah, 84132, United States
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Elizabeth Vale, 5112, Australia
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Kogarah, 2217, Australia
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South Brisbane, QL 4101, Australia
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Woolloongabba, 4102, Australia
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Vienna, 1090, Austria
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Wels, 4600, Austria
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Bruges, 8310, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Botucatu, 18618-687, Brazil
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Brasília, 71681-603, Brazil
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Caxias do Sul, 95070-560, Brazil
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Curitiba, 80250-060, Brazil
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Curitiba, 80440-220, Brazil
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Porto Alegre, 90035-903, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 05.403-010, Brazil
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Hamilton, Ontario, L8S 1G5, Canada
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London, Ontario, N6A 5W9, Canada
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Niagara Falls, Ontario, L2H 1H5, Canada
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Ottawa, Ontario, K1H 1E4, Canada
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Windsor, Ontario, N8X 2G1, Canada
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Beijing, 100020, China
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Beijing, 100050, China
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Guangzhou, 510080, China
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Hangzhou, 310052, China
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Nanjing, 2100008, China
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Shanghai, 200000, China
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Shenyang, 110004, China
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Tianjin, 300050, China
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Wuhan, 430022, China
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Brno, 625 00, Czechia
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Hradec Králové, 500 12, Czechia
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Prague, 190 00, Czechia
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Gistrup, 9260, Denmark
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Køge, 4600, Denmark
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Odense, 5000, Denmark
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Helsinki, 00290, Finland
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München, 81675, Germany
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Athens, 11521, Greece
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Athens, 11527, GR, Greece
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Athens, 11527, Greece
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Athens, 12462, Greece
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Thessaloniki, 56429, Greece
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Holon, 58100, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 4920235, Israel
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Petah Tikva, 4941492, Israel
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Tel Aviv, 62748, Israel
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Tel Aviv, 6423906, Israel
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Tel Litwinsky, 52620, Israel
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Bologna, 40138, Italy
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Milan, 20162, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Pisa, 56124, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Verona, 37134, Italy
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Akita, 010-8543, Japan
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Fukuoka, 812-8582, Japan
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Himeji, 670-8560, Japan
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Hiroshima, 734-8551, Japan
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Isehara-shi, 259-1193, Japan
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Kawasaki-shi, 211-0063, Japan
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Maebashi, 371-8511, Japan
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Minatoku, 108-8329, Japan
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Osaka, 545-8586, Japan
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Shinjuku-ku, 160-8582, Japan
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Shinjuku-ku, 162-8655, Japan
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Yamagata, 990-9585, Japan
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Amsterdam, 1081 HV, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Christchurch, 8011, New Zealand
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Hamilton, 3204, New Zealand
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Newtown, 6021, New Zealand
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Otahuhu, 2025, New Zealand
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Ålesund, 6026, Norway
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Lørenskog, 1478, Norway
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Lørenskog, N-1478, Norway
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Oslo, 0450, Norway
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Tromsø, N-9038, Norway
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Košice, 04013, Slovakia
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Madrid, 28006, Spain
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Madrid, 28007, Spain
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Madrid, 28031, Spain
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Pamplona, 31008, Spain
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Seville, 41009, Spain
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Seville, 41013, Spain
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Tomelloso, 13700, Spain
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Stockholm, 171 76, Sweden
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Trollhättan, 461 73, Sweden
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Uppsala, 751 85, Sweden
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London, SW17 0QT, United Kingdom
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London, WC1N 3JH, United Kingdom

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