Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

NCT05583227 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: D5244C000012022-001294-31
• Study Type: interventional
• Target: 368
• Locations: 21 countries
• Sites: 123

Brief 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).

Conditions

Eosinophilic Esophagitis

Keywords

Chronic Esophagitis; Eosinophilic Esophagitis; Eosinophilic

Outcome Measures

Primary Outcomes (2)

• Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels

  Peak esophageal eosinophil count per HPF determined by histological analysis of 2-4 biopsies from each of the proximal, mid, and distal esophagus.

  Week 24

• Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score

  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.

  Week 24

Secondary Outcomes (8)

• Change from baseline in EoE EREFS (Endoscopic reference score )

  Week 24, Week 52

• Change from baseline in EoE-HSS (Histologic scoring system) grade score

  Week 24

• Change from baseline in EoE-HSS (Histologic scoring system) stage score

  Week 24

• Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels

  Week 52

• Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score

  Week 52

Other Outcomes (6)

• Change from baseline in peak esophageal eosinophil count (EOS/HPF)

  Week 24, Week 52

• Changes from baseline in PEESS Module at Week 24 (adolescents only).

  Week 24, Week 52

• Change from baseline in EoE-HSS (Histologic scoring system) stage score

  Week 52

Study Arms (3)

Tezepelumab Low Dose

EXPERIMENTAL

Tezepelumab subcutaneous injections, in accessorised pre-filled syringes

Biological: Tezepelumab

Tezepelumab High Dose

EXPERIMENTAL

Tezepelumab subcutaneous injections, in accessorised pre-filled syringes

Biological: Tezepelumab

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injections, in accessorised pre-filled syringes

Other: Placebo

Interventions

Tezepelumab BIOLOGICAL

Tezepelumab subcutaneous injection

Tezepelumab Low Dose

Placebo OTHER

Placebo subcutaneous injection

Placebo

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.
• Weight ≥ 40 kg at Visit 1
• Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.
• 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.
• 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).
• 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.
• 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).
• 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.
• Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.

You may not qualify if:

• 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.
• Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
• 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.
• Hypereosinophilic syndrome
• EGPA vasculitis
• Esophageal dilation performed within 8 weeks prior to screening.

Sponsors & Collaborators

• AstraZeneca: lead
• Amgen: collaborator

Study Sites (125)

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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Smithfield, Pennsylvania, 15478, 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, K1G 6C6, 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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Aalborg, 9000, 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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Kitakyushu-shi, 802-0077, 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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Related Links

• This webpage was designed to learn about the work AstraZeneca is doing to develop Eosinophilic Esophagitis (EoE) treatments and find out how you could get involved in a clinical trial.

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in a 1:1:1 ratio to receive either low dose of tezepelumab, high dose of tezepelumab, or placebo.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: November 10, 2022
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): March 23, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

ES (9); JP (13); US (24); GR (5); IT (9); NO (5); DK (3); GB (2); SE (3); AU (4); BR (8); FI (1); DE (1); BE (4); CA (5); CZ (3); CN (9); IL (7); NZ (4); SL (1); NL (3)