Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

Last updated: March 28, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Esophageal Disorders

Heartburn (Pediatric)

Heartburn

Treatment

Tezepelumab

Placebo

Clinical Study ID

NCT05583227
D5244C00001
2022-001294-31
  • Ages 12-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Weight ≥ 40 kg at Visit 1

  3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming adiagnosis 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 inthe 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 duringthe course of the study (stable diet is defined as no initiation of single ormultiple 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 asbackground medications have been stable for at least 8 weeks prior to thescreening/run-in period (Visit 1) and there is agreement not to change backgroundmedication or dosage unless medically indicated, during the screening/run-in andtreatment period.

  7. Participants currently on leukotriene inhibitors and/or steroid treatments forasthma or allergies that are inhaled or administered intranasally, must report astable 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 thescreening/run-in, there should be a washout period of at least 8 weeks prior toVisit 1. Discontinuation of any marketed biologic (monoclonal or polyclonalantibody) 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, whichcould include PPI and/or STC and/or diet.

Exclusion

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 significantgastrointestinal conditions as per Investigator discretion.

  2. Esophageal stricture that prevents the easy passage of a standard endoscope or anycritical 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.

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Tezepelumab
Phase: 3
Study Start date:
November 10, 2022
Estimated Completion Date:
January 08, 2027

Study Description

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.

Connect with a study center

  • Research Site

    Elizabeth Vale, 5112
    Australia

    Active - Recruiting

  • Research Site

    Kogarah, 2217
    Australia

    Active - Recruiting

  • Research Site

    Mitcham, 3132
    Australia

    Site Not Available

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    South Brisbane, QL 4101
    Australia

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    Woolloongabba, 4102
    Australia

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    Graz, 8036
    Austria

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    Wels-Grieskirchen, 4600
    Austria

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    Wien, 1090
    Austria

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    Brugge, 8310
    Belgium

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    Edegem, 2650
    Belgium

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  • Research Site

    Gent, 9000
    Belgium

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  • Research Site

    Leuven, 3000
    Belgium

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  • Research Site

    Botucatu, 18618-687
    Brazil

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  • Research Site

    Brasilia, 71681-603
    Brazil

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    Caxias do Sul, 95070-560
    Brazil

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    Curitiba, 80440-220
    Brazil

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    Porto Alegre, 90050-170
    Brazil

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    Sao Paulo, 05.403-010
    Brazil

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    São José do Rio Preto, 15090-000
    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 K1G 6C6
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    Windsor, Ontario N8X 2G1
    Canada

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    Montreal, Quebec H4A 3T2
    Canada

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    Beijing, 100020
    China

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    Changsha, 430033
    China

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    Guangzhou, 510515
    China

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    Hangzhou, 310052
    China

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    Nanjing, 2100008
    China

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    Shanghai, 200025
    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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    Zhengzhou, 450052
    China

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    Brno, 625 00
    Czechia

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    Hradec Kralove, 500 12
    Czechia

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    Praha, 190 00
    Czechia

    Completed

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    Aalborg, 9000
    Denmark

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    Køge, 4600
    Denmark

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    Odense, 5000
    Denmark

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    Helsinki, 00100
    Finland

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    Hämeenlinna, 13530
    Finland

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    Kuopio, 70210
    Finland

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    Turku, 20520
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    Frankfurt, 60590
    Germany

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    Landsberg, 86899
    Germany

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    München, 81675
    Germany

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    Athens, 11521
    Greece

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    Thessaloniki, 54642
    Greece

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    Haifa, 31048
    Israel

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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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    Tel Aviv, 62748
    Israel

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    Tel Hashomer, 52620
    Israel

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    Bologna, 40138
    Italy

    Terminated

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    Milano, 20162
    Italy

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    Napoli, 80131
    Italy

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    Padova, 35128
    Italy

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    Pisa, 56124
    Italy

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    Roma, 00168
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    Rozzano, 20089
    Italy

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    Verona, 37134
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    Akita-shi, 010-8543
    Japan

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    Fukuoka-shi, 812-8582
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    Himeji, 670-8560
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    Hiroshima-shi, 734-8551
    Japan

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    Isehara-shi, 259-1193
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    Kawasaki-shi, 211-0063
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    Kitakyushu-shi, 802-0077
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    Maebashi-shi, 371-8511
    Japan

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    Minato-ku, 105-8471
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    Osaka, 545-8586
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    Shinjuku-ku, 162-8655
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    Yamagata-shi, 990-9585
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    Amsterdam, 1081 HV
    Netherlands

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    Nijmegen, 6525 GA
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    Rotterdam, 3015 GD
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    Christchurch, 8011
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    Otahuhu, 2025
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    Slovakia

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    Martin, 03601
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    Bilbao (Vizcaya), 48013
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    Pamplona, 31008
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    Sevilla, 41013
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    Tomelloso, 13700
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    Sweden

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    Trollhättan, 461 73
    Sweden

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    Uppsala, 751 85
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    Brighton, BN2 1ES
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    Phoenix, Arizona 85016
    United States

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    Los Angeles, California 90033
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    Aurora, Colorado 80045
    United States

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    Inverness, Florida 34452
    United States

    Completed

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    Jacksonville, Florida 32256
    United States

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    Saint Augustine, Florida 32086
    United States

    Completed

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    Atlanta, Georgia 30322
    United States

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    Chicago, Illinois 60611
    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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  • Research Site

    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
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    Teaneck, New Jersey 07666
    United States

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    Brooklyn, New York 11235
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    Chapel Hill, North Carolina 27599
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    Winston-Salem, North Carolina 27157
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    United States

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    Philadelphia, Pennsylvania 19104
    United States

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    Smithfield, Pennsylvania 15478
    United States

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    Greenville, South Carolina 29615
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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 84132
    United States

    Active - Recruiting

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    Charlottesville, Virginia 22908
    United States

    Site Not Available

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