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ACTIVE NOT RECRUITING

NCT05583227

PHASE3

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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).

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).

Key Details

Gender

All

Age Range

12 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

368

Start Date

2022-11-10

Completion Date

2027-03-23

Last Updated

2026-01-16

Healthy Volunteers

Conditions

Eosinophilic Esophagitis

Interventions

BIOLOGICAL

Tezepelumab

Tezepelumab subcutaneous injection

BIOLOGICAL

Tezepelumab

Tezepelumab subcutaneous injection

OTHER

Placebo

Placebo subcutaneous injection

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.

Locations (125)

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Aurora, Colorado, United States

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Inverness, Florida, United States

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Jacksonville, Florida, United States

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Saint Augustine, Florida, United States

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Normal, Illinois, United States

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Iowa City, Iowa, United States

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Topeka, Kansas, United States

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White Marsh, Maryland, United States

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Boston, Massachusetts, United States

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Chesterfield, Michigan, United States

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Lincoln, Nebraska, United States

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Ocean City, New Jersey, United States

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Brooklyn, New York, United States

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Chapel Hill, North Carolina, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Smithfield, Pennsylvania, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Elizabeth Vale, Australia

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Kogarah, Australia

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South Brisbane, Australia

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Woolloongabba, Australia

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Vienna, Austria

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Wels, Austria

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Bruges, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Botucatu, Brazil

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Brasília, Brazil

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Caxias do Sul, Brazil

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Curitiba, Brazil

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Curitiba, Brazil

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Porto Alegre, Brazil

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São José do Rio Preto, Brazil

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São Paulo, Brazil

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Niagara Falls, Ontario, Canada

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Ottawa, Ontario, Canada

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Windsor, Ontario, Canada

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Beijing, China

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Beijing, China

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Guangzhou, China

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Hangzhou, China

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Nanjing, China

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Shanghai, China

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Shenyang, China

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Tianjin, China

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Wuhan, China

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Brno, Czechia

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Hradec Králové, Czechia

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Prague, Czechia

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Aalborg, Denmark

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Køge, Denmark

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Odense, Denmark

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Helsinki, Finland

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München, Germany

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Thessaloniki, Greece

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Holon, Israel

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Jerusalem, Israel

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Petah Tikva, Israel

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Petah Tikva, Israel

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Tel Aviv, Israel

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Tel Aviv, Israel

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Tel Litwinsky, Israel

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Bologna, Italy

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Milan, Italy

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Naples, Italy

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Padova, Italy

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Pisa, Italy

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Roma, Italy

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Roma, Italy

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Rozzano, Italy

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Verona, Italy

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Akita, Japan

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Fukuoka, Japan

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Himeji, Japan

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Hiroshima, Japan

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Isehara-shi, Japan

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Kawasaki-shi, Japan

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Kitakyushu-shi, Japan

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Maebashi, Japan

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Minatoku, Japan

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Osaka, Japan

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Shinjuku-ku, Japan

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Shinjuku-ku, Japan

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Yamagata, Japan

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Amsterdam, Netherlands

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Nijmegen, Netherlands

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Rotterdam, Netherlands

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Christchurch, New Zealand

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Hamilton, New Zealand

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Newtown, New Zealand

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Otahuhu, New Zealand

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Ålesund, Norway

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Lørenskog, Norway

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Lørenskog, Norway

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Oslo, Norway

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Tromsø, Norway

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Košice, Slovakia

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Barcelona, Spain

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Pamplona, Spain

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Seville, Spain

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Seville, Spain

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Tomelloso, Spain

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Stockholm, Sweden

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Trollhättan, Sweden

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Uppsala, Sweden

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London, United Kingdom

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London, United Kingdom

Clinical Research Directory

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (125)