Eosinophilic EsophagitisPhase 3CROSSINGNCT05583227
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
A Phase 3 study testing Tezepelumab in people with Eosinophilic Esophagitis, run by AstraZeneca at 124 sites in 22 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Tezepelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 124 sitesin 22 countries
- Study dates
- 10 Nov 2022to 23 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
124 sites in 22 countries.
124 sites in 22 countries
United States24 sites
Research Site
Aurora, Colorado, 80045
Research Site
Boston, Massachusetts, 02111
Research Site
Brooklyn, New York, 11235
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Chesterfield, Michigan, 48047
Research Site
Cincinnati, Ohio, 45229
Research Site
Houston, Texas, 77030
Research Site
Inverness, Florida, 34452
Research Site
Iowa City, Iowa, 52242
Research Site
Jacksonville, Florida, 32256
Research Site
Lincoln, Nebraska, 68503
Research Site
Little Rock, Arkansas, 72202
Research Site
Los Angeles, California, 90033
Research Site
Nashville, Tennessee, 37232
Research Site
Normal, Illinois, 61761
Research Site
Ocean City, New Jersey, 07712
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Phoenix, Arizona, 85016
Research Site
Saint Augustine, Florida, 32086
Research Site
Salt Lake City, Utah, 84107
Research Site
Salt Lake City, Utah, 84132
Research Site
Topeka, Kansas, 66606
Research Site
Uniontown, Pennsylvania, 15401
Research Site
White Marsh, Maryland, 21162
Japan12 sites
Research Site
Akita, 010-8543
Research Site
Fukuoka, 812-8582
Research Site
Himeji, 670-8560
Research Site
Hiroshima, 734-8551
Research Site
Isehara-shi, 259-1193
Research Site
Kawasaki-shi, 211-0063
Research Site
Maebashi, 371-8511
Research Site
Minatoku, 108-8329
Research Site
Osaka, 545-8586
Research Site
Shinjuku-ku, 160-8582
Research Site
Shinjuku-ku, 162-8655
Research Site
Yamagata, 990-9585
China9 sites
Research Site
Beijing, 100020
Research Site
Beijing, 100050
Research Site
Guangzhou, 510080
Research Site
Hangzhou, 310052
Research Site
Nanjing, 2100008
Research Site
Shanghai, 200000
Research Site
Shenyang, 110004
Research Site
Tianjin, 300050
Research Site
Wuhan, 430022
Italy9 sites
Research Site
Bologna, 40138
Research Site
Milan, 20162
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Pisa, 56124
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Roma, 00161
Research Site
Roma, 00168
Research Site
Rozzano, 20089
Research Site
Verona, 37134
Spain9 sites
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Madrid, 28006
Research Site
Madrid, 28007
Research Site
Madrid, 28031
Research Site
Pamplona, 31008
Research Site
Seville, 41009
Research Site
Seville, 41013
Research Site
Tomelloso, 13700
Brazil8 sites
Research Site
Botucatu, 18618-687
Research Site
Brasília, 71681-603
Research Site
Caxias do Sul, 95070-560
Research Site
Curitiba, 80250-060
Research Site
Curitiba, 80440-220
Research Site
Porto Alegre, 90035-903
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 05403-000
Israel7 sites
Research Site
Holon, 58100
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Jerusalem, 91120
Research Site
Petah Tikva, 4920235
Research Site
Petah Tikva, 4941492
Research Site
Tel Aviv, 62748
Research Site
Tel Aviv, 6423906
Research Site
Tel HaShomer, 52620
Canada5 sites
Research Site
Hamilton, Ontario, L8S 1G5
Research Site
London, Ontario, N6A 5W9
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Niagara Falls, Ontario, L2H 1H5
Research Site
Ottawa, Ontario, K1H 1E4
Research Site
Windsor, Ontario, N8X 2G1
Greece5 sites
Research Site
Athens, 11521
Research Site
Athens, 11527, GR
Research Site
Athens, 11527
Research Site
Athens, 12462
Research Site
Thessaloniki, 56429
Norway5 sites
Research Site
Ålesund, 6026
Research Site
Lørenskog, 1478
Research Site
Lørenskog, N-1478
Research Site
Oslo, 0450
Research Site
Tromsø, N-9038
Australia4 sites
Research Site
Elizabeth Vale, 5112
Research Site
Kogarah, 2217
Research Site
South Brisbane, QL 4101
Research Site
Woolloongabba, 4102
Belgium4 sites
Research Site
Bruges, 8310
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Leuven, 3000
New Zealand4 sites
Research Site
Christchurch, 8011
Research Site
Hamilton, 3240
Research Site
Otahuhu, 2025
Research Site
Wellington, 6021
Czechia3 sites
Research Site
Brno, 625 00
Research Site
Hradec Králové, 500 12
Research Site
Prague, 190 00
Denmark3 sites
Research Site
Gistrup, 9260
Research Site
Køge, 4600
Research Site
Odense, 5000
Netherlands3 sites
Research Site
Amsterdam, 1081 HV
Research Site
Nijmegen, 6525 GA
Research Site
Rotterdam, 3015 GD
Sweden3 sites
Research Site
Stockholm, 171 76
Research Site
Trollhättan, 461 73
Research Site
Uppsala, 751 85
United Kingdom2 sites
Research Site
London, SW17 0QT
Research Site
London, WC1N 3JH
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).
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).
Read the detailed 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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Tezepelumab, Placebo
- Keywords
- Chronic Esophagitis, Eosinophilic Esophagitis, Eosinophilic
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabBiological
Tezepelumab subcutaneous injection
TezepelumabBiological
Tezepelumab subcutaneous injection
PlaceboOther
Placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Tezepelumab Low Dose | Experimental | Tezepelumab subcutaneous injections, in accessorised pre-filled syringes Receives: Biological: Tezepelumab |
| Tezepelumab High Dose | Experimental | Tezepelumab subcutaneous injections, in accessorised pre-filled syringes Receives: Biological: Tezepelumab |
| Placebo | Placebo comparator | Placebo subcutaneous injections, in accessorised pre-filled syringes Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 24
Secondary outcomes (8)
Change from baseline in EoE EREFS (Endoscopic reference score )
The EoE EREFS is a scoring system for assessing the presence and severity of the major endoscopic signs of EoE, including esophageal edema, rings, exudates, furrows, and stricture.
EoE endoscopic appearances will be analyzed by the EoE-EREFS, a scoring system for inflammatory and fibrostenotic features of the disease. Proximal and distal esophageal areas will be scored, with the score for each region ranging from 0 to 9, and the overall score ranging from 0 to 18. Higher scores indicate more extensive disease.
Measured: Week 24, Week 52
Change from baseline in EoE-HSS (Histologic scoring system) grade score
EoE HSS is a histology scoring system for esophageal biopsies that evaluates 8 features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities are scored using a 4-point scale (0 normal; 3 maximum change).
Measured: Week 24
Change from baseline in EoE-HSS (Histologic scoring system) stage score
EoE HSS is a histology scoring system for esophageal biopsies that evaluates 8 features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities are scored using a 4-point scale (0 normal; 3 maximum change).
Measured: Week 24
Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels
The peak esophageal eosinophil count is based on 2-4 esophageal biopsies from 2-3 locations.
Measured: Week 52
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.
Measured: Week 52
Endoscopic response of total EREFS score of 0 to ≤2 with no score > 1 for any of the components and no worsening in any individual component from baseline accross all esophageal levels
EoE endoscopic appearances will be analyzed by the EoE-EREFS, a scoring system for inflammatory and fibrostenotic features of the disease. For each of the EREFS compontents a maximum score across proximal, mid and distal esophageal areas will be selected, with the scores for edema and stricture ranging from 0 to 1, exudates and furrows ranging from 0 to 2, fixed rings ranging from 0 to 3, and overall maximum score ranging from 0 to 9.
Measured: Week 52
Endoscopic inflammatory remission of EREFS inflammatory subscore (including edema, exudate, and furrows components) of 0 with no worsening in rings or stricture from baseline across all esophageal levels)
EoE endoscopic appearances will be analyzed by the EoE-EREFS, a scoring system for inflammatory and fibrostenotic features of the disease. For each of the EREFS compontents a maximum score across proximal, mid and distal esophageal areas will be selected, with the scores for edema and stricture ranging from 0 to 1, exudates and furrows ranging from 0 to 2, fixed rings ranging from 0 to 3, and overall maximum score ranging from 0 to 9.
Measured: Week 52
Total endoscopic remission of total EREFS score of 0 across all esophageal levels
EoE endoscopic appearances will be analyzed by the EoE-EREFS, a scoring system for inflammatory and fibrostenotic features of the disease. For each of the EREFS compontents a maximum score across proximal, mid and distal esophageal areas will be selected, with the scores for edema and stricture ranging from 0 to 1, exudates and furrows ranging from 0 to 2, fixed rings ranging from 0 to 3, and overall maximum score ranging from 0 to 9.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start10 Nov 2022
- Primary completion14 Jul 2026
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in a 1:1:1 ratio to receive either low dose of tezepelumab, high dose of tezepelumab, or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583227
- Sponsor's protocol ID
- D5244C00001
- Other IDs
- 2022-001294-31
- Acronym
- CROSSING
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).
- ClinicalTrials.gov ID
- NCT05583227
- Acronym / sponsor ID
- CROSSING / D5244C00001
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Chronic Esophagitis, Eosinophilic Esophagitis, Eosinophilic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 368 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomized in a 1:1:1 ratio to receive either low dose of tezepelumab, high dose of tezepelumab, or placebo.
| Arm | Type | Receives |
|---|---|---|
| Tezepelumab Low Dose | Experimental | Biological: TezepelumabTezepelumab subcutaneous injections, in accessorised pre-filled syringes |
| Tezepelumab High Dose | Experimental | Biological: TezepelumabTezepelumab subcutaneous injections, in accessorised pre-filled syringes |
| Placebo | Placebo comparator | Other: PlaceboPlacebo subcutaneous injections, in accessorised pre-filled syringes |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TezepelumabTezepelumab subcutaneous injection | Biological | Tezepelumab Low Dose |
| TezepelumabTezepelumab subcutaneous injection | Biological | Tezepelumab High Dose |
| PlaceboPlacebo subcutaneous injection | Other | Placebo |
Primary outcome
Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels
Time frame: Week 24
Peak esophageal eosinophil count per HPF determined by histological analysis of 2-4 biopsies from each of the proximal, mid, and distal esophagus.
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
Time frame: Week 24
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.
8 secondary outcomes
Change from baseline in EoE EREFS (Endoscopic reference score )
Time frame: Week 24, Week 52
Change from baseline in EoE-HSS (Histologic scoring system) grade score
Time frame: Week 24
Change from baseline in EoE-HSS (Histologic scoring system) stage score
Time frame: Week 24
Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels
Time frame: Week 52
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
Time frame: Week 52
Endoscopic response of total EREFS score of 0 to ≤2 with no score > 1 for any of the components and no worsening in any individual component from baseline accross all esophageal levels
Time frame: Week 52
Endoscopic inflammatory remission of EREFS inflammatory subscore (including edema, exudate, and furrows components) of 0 with no worsening in rings or stricture from baseline across all esophageal levels)
Time frame: Week 52
Total endoscopic remission of total EREFS score of 0 across all esophageal levels
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
124 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tezepelumab in people with Eosinophilic Esophagitis, run by AstraZeneca at 124 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 124 sites in United States, Japan, China, Italy, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.