FARE - Food Allergy Research & Education Logo

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05583227
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, Germany, Greece, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Slovakia, Spain, Sweden, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Study Website: View Trial Website
Additional Details

The study consists of a screening period of 2 to 8 weeks and a 52-week randomized double-blind placebo-controlled treatment period. After completion of the treatment period, participants will be eligible to participate in an optional active treatment extension period (lasting for 24 weeks), followed by a 12-week off-treatment safety follow-up period. Participants who will not participate in the extension period will participate in a 12-week off-treatment safety follow-up period following completion of the 52-week treatment period. This study will randomize approximately 360 participants. The participants will be randomized at 1:1:1 ratio to the 3 treatment arms.

Arms & Interventions

Arms

Experimental: Tezepelumab Low Dose

Tezepelumab subcutaneous injections, in accessorised pre-filled syringes

Experimental: Tezepelumab High Dose

Tezepelumab subcutaneous injections, in accessorised pre-filled syringes

Placebo Comparator: Placebo

Placebo subcutaneous injections, in accessorised pre-filled syringes

Interventions

Biological: - Tezepelumab

Tezepelumab subcutaneous injection

Biological: - Tezepelumab

Tezepelumab subcutaneous injection

Other: - Placebo

Placebo subcutaneous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Phoenix, Arizona

Status

Recruiting

Address

Research Site

Phoenix, Arizona, 85016

Research Site, Little Rock, Arkansas

Status

Recruiting

Address

Research Site

Little Rock, Arkansas, 72202

Research Site, Los Angeles, California

Status

Recruiting

Address

Research Site

Los Angeles, California, 90033

Research Site, Aurora, Colorado

Status

Not yet recruiting

Address

Research Site

Aurora, Colorado, 80045

Research Site, Inverness, Florida

Status

Recruiting

Address

Research Site

Inverness, Florida, 34452

Research Site, Jacksonville, Florida

Status

Recruiting

Address

Research Site

Jacksonville, Florida, 32256

Research Site, Saint Augustine, Florida

Status

Recruiting

Address

Research Site

Saint Augustine, Florida, 32086

Research Site, Atlanta, Georgia

Status

Withdrawn

Address

Research Site

Atlanta, Georgia, 30322

Research Site, Chicago, Illinois

Status

Withdrawn

Address

Research Site

Chicago, Illinois, 60611

Research Site, Normal, Illinois

Status

Recruiting

Address

Research Site

Normal, Illinois, 61761

Research Site, Iowa City, Iowa

Status

Recruiting

Address

Research Site

Iowa City, Iowa, 52242

Research Site, Topeka, Kansas

Status

Recruiting

Address

Research Site

Topeka, Kansas, 66606

Research Site, White Marsh, Maryland

Status

Recruiting

Address

Research Site

White Marsh, Maryland, 21162

Research Site, Boston, Massachusetts

Status

Recruiting

Address

Research Site

Boston, Massachusetts, 02111

Research Site, Chesterfield, Michigan

Status

Recruiting

Address

Research Site

Chesterfield, Michigan, 48047

Research Site, Lincoln, Nebraska

Status

Suspended

Address

Research Site

Lincoln, Nebraska, 68503

Research Site, Teaneck, New Jersey

Status

Recruiting

Address

Research Site

Teaneck, New Jersey, 07666

Research Site, Brooklyn, New York

Status

Recruiting

Address

Research Site

Brooklyn, New York, 11235

Research Site, Chapel Hill, North Carolina

Status

Recruiting

Address

Research Site

Chapel Hill, North Carolina, 27599

Research Site, Winston-Salem, North Carolina

Status

Withdrawn

Address

Research Site

Winston-Salem, North Carolina, 27157

Research Site, Cincinnati, Ohio

Status

Recruiting

Address

Research Site

Cincinnati, Ohio, 45229

Research Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

Research Site

Philadelphia, Pennsylvania, 19104

Research Site, Smithfield, Pennsylvania

Status

Recruiting

Address

Research Site

Smithfield, Pennsylvania, 15478

Research Site, Greenville, South Carolina

Status

Withdrawn

Address

Research Site

Greenville, South Carolina, 29615

Research Site, Nashville, Tennessee

Status

Recruiting

Address

Research Site

Nashville, Tennessee, 37232

Research Site, Houston, Texas

Status

Recruiting

Address

Research Site

Houston, Texas, 77030

Research Site, Salt Lake City, Utah

Status

Recruiting

Address

Research Site

Salt Lake City, Utah, 84107

Research Site, Salt Lake City, Utah

Status

Recruiting

Address

Research Site

Salt Lake City, Utah, 84132

Research Site, Charlottesville, Virginia

Status

Withdrawn

Address

Research Site

Charlottesville, Virginia, 22908

International Sites

Research Site, Elizabeth Vale, Australia

Status

Recruiting

Address

Research Site

Elizabeth Vale, , 5112

Research Site, Kogarah, Australia

Status

Recruiting

Address

Research Site

Kogarah, , 2217

Research Site, Mitcham, Australia

Status

Recruiting

Address

Research Site

Mitcham, , 3132

Research Site, South Brisbane, Australia

Status

Recruiting

Address

Research Site

South Brisbane, , QL 4101

Research Site, Woolloongabba, Australia

Status

Recruiting

Address

Research Site

Woolloongabba, , 4102

Research Site, Graz, Austria

Status

Recruiting

Address

Research Site

Graz, , 8036

Research Site, Wels-Grieskirchen, Austria

Status

Recruiting

Address

Research Site

Wels-Grieskirchen, , 4600

Research Site, Wien, Austria

Status

Recruiting

Address

Research Site

Wien, , 1090

Research Site, Brugge, Belgium

Status

Recruiting

Address

Research Site

Brugge, , 8310

Research Site, Edegem, Belgium

Status

Recruiting

Address

Research Site

Edegem, , 2650

Research Site, Gent, Belgium

Status

Recruiting

Address

Research Site

Gent, , 9000

Research Site, Leuven, Belgium

Status

Recruiting

Address

Research Site

Leuven, , 3000

Research Site, Botucatu, Brazil

Status

Recruiting

Address

Research Site

Botucatu, , 18618-687

Research Site, Brasilia, Brazil

Status

Recruiting

Address

Research Site

Brasilia, , 71681-603

Research Site, Caxias do Sul, Brazil

Status

Recruiting

Address

Research Site

Caxias do Sul, , 95070-560

Research Site, Curitiba, Brazil

Status

Recruiting

Address

Research Site

Curitiba, , 80250-060

Research Site, Curitiba, Brazil

Status

Recruiting

Address

Research Site

Curitiba, , 80440-220

Research Site, Porto Alegre, Brazil

Status

Recruiting

Address

Research Site

Porto Alegre, , 90035-903

Research Site, Porto Alegre, Brazil

Status

Withdrawn

Address

Research Site

Porto Alegre, , 90050-170

Research Site, Sao Paulo, Brazil

Status

Not yet recruiting

Address

Research Site

Sao Paulo, , 05.403-010

Research Site, São José do Rio Preto, Brazil

Status

Recruiting

Address

Research Site

São José do Rio Preto, , 15090-000

Research Site, Hamilton, Ontario, Canada

Status

Recruiting

Address

Research Site

Hamilton, Ontario, L8S 1G5

Research Site, London, Ontario, Canada

Status

Recruiting

Address

Research Site

London, Ontario, N6A 5W9

Research Site, Niagara Falls, Ontario, Canada

Status

Recruiting

Address

Research Site

Niagara Falls, Ontario, L2H 1H5

Research Site, Ottawa, Ontario, Canada

Status

Recruiting

Address

Research Site

Ottawa, Ontario, K1G 6C6

Research Site, Windsor, Ontario, Canada

Status

Recruiting

Address

Research Site

Windsor, Ontario, N8X 2G1

Research Site, Montreal, Quebec, Canada

Status

Recruiting

Address

Research Site

Montreal, Quebec, H4A 3T2

Research Site, Beijing, China

Status

Recruiting

Address

Research Site

Beijing, , 100020

Research Site, Beijing, China

Status

Recruiting

Address

Research Site

Beijing, , 100050

Research Site, Changsha, China

Status

Not yet recruiting

Address

Research Site

Changsha, , 430033

Research Site, Guangzhou, China

Status

Recruiting

Address

Research Site

Guangzhou, , 510080

Research Site, Guangzhou, China

Status

Not yet recruiting

Address

Research Site

Guangzhou, , 510515

Research Site, Hangzhou, China

Status

Recruiting

Address

Research Site

Hangzhou, , 310052

Research Site, Nanjing, China

Status

Not yet recruiting

Address

Research Site

Nanjing, , 2100008

Research Site, Shanghai, China

Status

Not yet recruiting

Address

Research Site

Shanghai, , 200000

Research Site, Shanghai, China

Status

Recruiting

Address

Research Site

Shanghai, , 200025

Research Site, Shenyang, China

Status

Not yet recruiting

Address

Research Site

Shenyang, , 110004

Research Site, Tianjin, China

Status

Recruiting

Address

Research Site

Tianjin, , 300052

Research Site, Wuhan, China

Status

Recruiting

Address

Research Site

Wuhan, , 430022

Research Site, Zhengzhou, China

Status

Recruiting

Address

Research Site

Zhengzhou, ,

Research Site, Brno, Czechia

Status

Recruiting

Address

Research Site

Brno, , 625 00

Research Site, Hradec Kralove, Czechia

Status

Recruiting

Address

Research Site

Hradec Kralove, , 500 12

Research Site, Praha, Czechia

Status

Recruiting

Address

Research Site

Praha, , 190 00

Research Site, Aalborg, Denmark

Status

Recruiting

Address

Research Site

Aalborg, , 9000

Research Site, Køge, Denmark

Status

Recruiting

Address

Research Site

Køge, , 4600

Research Site, Odense, Denmark

Status

Recruiting

Address

Research Site

Odense, , 5000

Research Site, Helsinki, Finland

Status

Withdrawn

Address

Research Site

Helsinki, , 00100

Research Site, Helsinki, Finland

Status

Not yet recruiting

Address

Research Site

Helsinki, , 00290

Research Site, Helsinki, Finland

Status

Recruiting

Address

Research Site

Helsinki, , 00290

Research Site, Hämeenlinna, Finland

Status

Withdrawn

Address

Research Site

Hämeenlinna, , 13530

Research Site, Kuopio, Finland

Status

Recruiting

Address

Research Site

Kuopio, , 70210

Research Site, Turku, Finland

Status

Recruiting

Address

Research Site

Turku, , 20520

Research Site, Frankfurt, Germany

Status

Not yet recruiting

Address

Research Site

Frankfurt, , 60590

Research Site, Landsberg, Germany

Status

Withdrawn

Address

Research Site

Landsberg, , 86899

Research Site, München, Germany

Status

Withdrawn

Address

Research Site

München, , 80337

Research Site, München, Germany

Status

Recruiting

Address

Research Site

München, , 81675

Research Site, Athens, Greece

Status

Recruiting

Address

Research Site

Athens, , 11521

Research Site, Athens, Greece

Status

Recruiting

Address

Research Site

Athens, , 11527, GR

Research Site, Athens, Greece

Status

Recruiting

Address

Research Site

Athens, , 11527

Research Site, Athens, Greece

Status

Recruiting

Address

Research Site

Athens, , 12462

Research Site, Thessaloniki, Greece

Status

Recruiting

Address

Research Site

Thessaloniki, , 56429

Research Site, Haifa, Israel

Status

Recruiting

Address

Research Site

Haifa, , 31048

Research Site, Holon, Israel

Status

Recruiting

Address

Research Site

Holon, , 58100

Research Site, Petah Tikva, Israel

Status

Recruiting

Address

Research Site

Petah Tikva, , 4920235

Research Site, Petah Tikva, Israel

Status

Recruiting

Address

Research Site

Petah Tikva, , 4941492

Research Site, Tel Aviv, Israel

Status

Recruiting

Address

Research Site

Tel Aviv, , 62748

Research Site, Tel Aviv, Israel

Status

Recruiting

Address

Research Site

Tel Aviv, , 6423906

Research Site, Tel Hashomer, Israel

Status

Recruiting

Address

Research Site

Tel Hashomer, , 52620

Research Site, Bologna, Italy

Status

Recruiting

Address

Research Site

Bologna, , 40138

Research Site, Milano, Italy

Status

Recruiting

Address

Research Site

Milano, , 20162

Research Site, Napoli, Italy

Status

Recruiting

Address

Research Site

Napoli, , 80131

Research Site, Napoli, Italy

Status

Withdrawn

Address

Research Site

Napoli, , 80131

Research Site, Padova, Italy

Status

Recruiting

Address

Research Site

Padova, , 35128

Research Site, Pisa, Italy

Status

Recruiting

Address

Research Site

Pisa, , 56124

Research Site, Roma, Italy

Status

Recruiting

Address

Research Site

Roma, , 00161

Research Site, Roma, Italy

Status

Recruiting

Address

Research Site

Roma, , 00168

Research Site, Rozzano, Italy

Status

Recruiting

Address

Research Site

Rozzano, , 20089

Research Site, Verona, Italy

Status

Recruiting

Address

Research Site

Verona, , 37134

Research Site, Akita-shi, Japan

Status

Recruiting

Address

Research Site

Akita-shi, , 010-8543

Research Site, Fukuoka-shi, Japan

Status

Recruiting

Address

Research Site

Fukuoka-shi, , 812-8582

Research Site, Isehara-shi, Japan

Status

Recruiting

Address

Research Site

Isehara-shi, , 259-1193

Research Site, Kawasaki-shi, Japan

Status

Recruiting

Address

Research Site

Kawasaki-shi, , 211-0063

Research Site, Kitakyushu-shi, Japan

Status

Not yet recruiting

Address

Research Site

Kitakyushu-shi, , 802-0077

Research Site, Maebashi-shi, Japan

Status

Not yet recruiting

Address

Research Site

Maebashi-shi, , 371-8511

Research Site, Minato-ku, Japan

Status

Withdrawn

Address

Research Site

Minato-ku, , 105-8471

Research Site, Minato-ku, Japan

Status

Recruiting

Address

Research Site

Minato-ku, , 108-8329

Research Site, Osaka, Japan

Status

Recruiting

Address

Research Site

Osaka, , 545-8586

Research Site, Shinjuku-ku, Japan

Status

Not yet recruiting

Address

Research Site

Shinjuku-ku, , 160-8582

Research Site, Shinjuku-ku, Japan

Status

Not yet recruiting

Address

Research Site

Shinjuku-ku, , 162-8655

Research Site, Yamagata-shi, Japan

Status

Recruiting

Address

Research Site

Yamagata-shi, , 990-9585

Research Site, Amsterdam, Netherlands

Status

Recruiting

Address

Research Site

Amsterdam, , 1105 AZ

Research Site, Nijmegen, Netherlands

Status

Recruiting

Address

Research Site

Nijmegen, , 6525 GA

Research Site, Rotterdam, Netherlands

Status

Not yet recruiting

Address

Research Site

Rotterdam, , 3015 GD

Research Site, Grafton, New Zealand

Status

Recruiting

Address

Research Site

Grafton, , 1023

Research Site, Hamilton, New Zealand

Status

Recruiting

Address

Research Site

Hamilton, , 3204

Research Site, Newtown, New Zealand

Status

Recruiting

Address

Research Site

Newtown, , 6021

Research Site, Otahuhu, New Zealand

Status

Recruiting

Address

Research Site

Otahuhu, , 2025

Research Site, Lørenskog, Norway

Status

Recruiting

Address

Research Site

Lørenskog, , 1478

Research Site, Lørenskog, Norway

Status

Recruiting

Address

Research Site

Lørenskog, , N-1478

Research Site, Oslo, Norway

Status

Recruiting

Address

Research Site

Oslo, , 0450

Research Site, Oslo, Norway

Status

Withdrawn

Address

Research Site

Oslo, , NO0424

Research Site, Tromsø, Norway

Status

Recruiting

Address

Research Site

Tromsø, , N-9038

Research Site, Ålesund, Norway

Status

Recruiting

Address

Research Site

Ålesund, , 6026

Research Site, Kosice, Slovakia

Status

Recruiting

Address

Research Site

Kosice, , 04013

Research Site, Martin, Slovakia

Status

Recruiting

Address

Research Site

Martin, , 03601

Research Site, Barcelona, Spain

Status

Recruiting

Address

Research Site

Barcelona, , 08035

Research Site, Barcelona, Spain

Status

Recruiting

Address

Research Site

Barcelona, , 08036

Research Site, Bilbao (Vizcaya), Spain

Status

Withdrawn

Address

Research Site

Bilbao (Vizcaya), , 48013

Research Site, Madrid, Spain

Status

Recruiting

Address

Research Site

Madrid, , 28006

Research Site, Madrid, Spain

Status

Recruiting

Address

Research Site

Madrid, , 28007

Research Site, Madrid, Spain

Status

Recruiting

Address

Research Site

Madrid, , 28031

Research Site, Pamplona, Spain

Status

Recruiting

Address

Research Site

Pamplona, , 31008

Research Site, Sevilla, Spain

Status

Recruiting

Address

Research Site

Sevilla, , 41009

Research Site, Sevilla, Spain

Status

Recruiting

Address

Research Site

Sevilla, , 41013

Research Site, Tomelloso, Spain

Status

Recruiting

Address

Research Site

Tomelloso, , 13700

Research Site, Stockholm, Sweden

Status

Recruiting

Address

Research Site

Stockholm, , 171 76

Research Site, Stockholm, Sweden

Status

Recruiting

Address

Research Site

Stockholm, , 17164

Research Site, Trollhättan, Sweden

Status

Recruiting

Address

Research Site

Trollhättan, , 461 73

Research Site, Uppsala, Sweden

Status

Recruiting

Address

Research Site

Uppsala, , 751 85

Research Site, Brighton, United Kingdom

Status

Withdrawn

Address

Research Site

Brighton, , BN2 1ES

Research Site, London, United Kingdom

Status

Not yet recruiting

Address

Research Site

London, , SW17 0QT

Research Site, London, United Kingdom

Status

Not yet recruiting

Address

Research Site

London, , WC1N 3JH

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.