Eosinophilic GastritisPhase 3HUDSON GINCT05251909
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
A Phase 3 study testing Benralizumab in people with Eosinophilic Gastritis and Eosinophilic Gastroenteritis, run by AstraZeneca at 20 sites in 9 countries.
Trial summary
This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Read more about this study
- Who is it for?
- Ages 12 to 130 years
- Conditions the study is for
- Eosinophilic Gastritis, Eosinophilic Gastroenteritis
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 18 Jan 2022to 13 Feb 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged >= 12 years of age at the time of signing the ICF or informed consent or assent form.
- Confirmed diagnosis of EG/EGE for at least 3 months prior to screening.
- Baseline Eosinophilic gastritis, with or without duodenitis, or eosinophilic duodenitis alone confirmed by biopsy with a gastric count of ≥30 eosinophils/hpf in at least 5 hpfs and/or duodenal eosinophil count ≥30 eosinophils/hpf in at least 3 hpfs without any other cause for the gastrointestinal eosinophilia.
- Symptoms including at least moderate abdominal pain, nausea, bloating, early satiety, and/or loss of appetite
- Must be adherent to daily PRO assessments including at least 8 of 14 symptom assessments in the 14 days prior to randomization
- If on background medications for EG/EGE, the medications should be stable at least 4 weeks prior to the run-in period.
- Willing and able to comply with all study procedures and visit schedule including follow-up visits
- Women of childbearing potential must agree to use a highly effective form of birth control (confirmed by the Investigator) from randomization throughout the study duration and within 12 weeks after last dose if IP.
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, or celiac disease.
- Hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis.
- Current malignancy, or history of malignancy, except for patients who have had basal cell, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date of informed consent.
- History of anaphylaxis to any biologic therapy or vaccine.
- Current active liver disease.
- Helminth parasitic infection diagnosed within 24 weeks prior to the date informed that has not been treated with or has failed to respond to standard of care therapy.
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- Known immunodeficiency disorder including testing positive for HIV.
- Concomitant use of immunosuppressive medication.
- Receipt of live attenuated vaccines 30 days prior to date of informed consent or assent.
- Receipt of inactive vaccines within 7 days of informed consent or assent.
- Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group from 6 weeks prior to start of the run-in period and unable or unwilling to remain on a stable diet until the completion of Part A and C.
- Currently pregnant or breast-feeding.
Trial locations and contacts
20 sites in 9 countries.
20 sites in 9 countries
United States7 sites
Research Site
Boston, Massachusetts, 02111
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Chicago, Illinois, 60611
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Rochester, Minnesota, 55905
Research Site
Salt Lake City, Utah, 84107
Research Site
Salt Lake City, Utah, 84132
Japan4 sites
Research Site
Bunkyō City, 113-8603
Research Site
Maebashi, 371-8511
Research Site
Ogaki-shi, 503-8502
Research Site
Shinjuku-ku, 162-8655
Italy3 sites
Research Site
Milan, 20122
Research Site
Padova, 35128
Research Site
Pisa, 56124
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close enrollment, patients in both Part A and Part C will be given the option to proceed to 6-months of open-label benralizumab treatment in Part D.
- Being tested
- Benralizumab, Placebo
- Keywords
- Benralizumab, Eosinophilic Gastritis, Gastroenteritis, Intestinal Diseases, Stomach Diseases, Gastrointestinal Diseases, Digestive System Diseases
- Medical subject headings
- Eosinophilic enteropathy, Gastroenteritis, Intestinal Diseases, Stomach Diseases, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabBiological
Also called Fasenra
Benralizumab is a humanized, afucosylated, monoclonal antibody that binds specifically to the IL-5Rα on the target cell and thus directly depletes eosinophils through antibody-dependent cell-mediated cytotoxicity. Benralizumab has been widely approved for treatment of asthma.
PlaceboBiological
Placebo will be injected as a comparator to injection with Benralizumab to examine effect on both the signs and symptoms of EG/EGE and the underlying eosinophilic inflammation, with dual primary outcome variables
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Experimental | This arm is a subcutaneous dose of Benralizumab Receives: Biological: Benralizumab |
| Placebo | Placebo comparator | This arm is a subcutaneous dose of Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With a Histologic Response at Week 24
the proportion of patients achieving a histological response at Week 24, is defined as below:
- 6 eosinophils/hpf in the stomach for the patients with only gastric disease at baseline.
- 6 eosinophils/hpf in the stomach and ≤15 eosinophils/hpf in the duodenum for the patients with gastric + duodenal disease at baseline.
- 15 eosinophils/hpf in the duodenum for the patients with only duodenal disease at baseline.
Measured: at week 24
Change From Baseline in SAGED Score at Week 24
The Symptom Assessment for Gastrointestinal Eosinophilic Diseases (SAGED) instrument was developed to measure gastrointestinal symptoms in participants diagnosed with EG/EGE. It is a daily diary completed by participants each evening from screening until week 76 to record symptoms during the past 24 hours. Severity for each concept is assessed using an 11-point numerical rating scale (0 = 'none' and 10 = 'worst imaginable'). The total SAGED score (range 0-50) is calculated as a 14-day mean of the sum of individual severity items of abdominal pain, nausea, bloating, early satiety and loss of appetite daily. Higher scores indicate greater symptom severity. Three additional items are collected that aren't part of the total SAGED score and are considered separately: severity of vomiting, severity of diarrhoea and frequency of vomiting. Change in SAGED score at week 24 is the week 24 score (study days 155 to 168) minus the baseline score (study days -14 to -1).
Measured: at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start18 Jan 2022
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Why it stopped: The study was terminated by the Sponsor based on emerging evidence in the pathology of eosinophilic upper gastrointestinal diseases. Recruitment for the study was terminated and only a small number of patients were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic GastritisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc E. Rothenberg, MD, PhD, Principal investigator, Cincinnati Children's Hospital Medical Center 3333 Burnet Ave, Cincinnati Ohio 45229, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251909
- Sponsor's protocol ID
- D3258C00001
- Other IDs
- 2021-000085-14
- Acronym
- HUDSON GI
- Status last verified
- Jun 2025
- First submitted
- 6 Aug 2021
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests 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 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
- ClinicalTrials.gov ID
- NCT05251909
- Acronym / sponsor ID
- HUDSON GI / D3258C00001
- Keywords
- Benralizumab, Eosinophilic Gastritis, Gastroenteritis, Intestinal Diseases, Stomach Diseases, Gastrointestinal Diseases, Digestive System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by the Sponsor based on emerging evidence in the pathology of eosinophilic upper gastrointestinal diseases. Recruitment for the study was terminated and only a small number of patients were recruited.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close enrollment, patients in both Part A and Part C will be given the option to proceed to 6-months of open-label benralizumab treatment in Part D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | Experimental | Biological: BenralizumabThis arm is a subcutaneous dose of Benralizumab |
| Placebo | Placebo comparator | Biological: PlaceboThis arm is a subcutaneous dose of Placebo |
Who may qualify
- Ages
- 12 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Aged >= 12 years of age at the time of signing the ICF or informed consent or assent form.
- Confirmed diagnosis of EG/EGE for at least 3 months prior to screening.
- Baseline Eosinophilic gastritis, with or without duodenitis, or eosinophilic duodenitis alone confirmed by biopsy with a gastric count of ≥30 eosinophils/hpf in at least 5 hpfs and/or duodenal eosinophil count ≥30 eosinophils/hpf in at least 3 hpfs without any other cause for the gastrointestinal eosinophilia.
- Symptoms including at least moderate abdominal pain, nausea, bloating, early satiety, and/or loss of appetite
- Must be adherent to daily PRO assessments including at least 8 of 14 symptom assessments in the 14 days prior to randomization
Key exclusion criteria (12 listed)
- Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, or celiac disease.
- Hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis.
- Current malignancy, or history of malignancy, except for patients who have had basal cell, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date of informed consent.
- History of anaphylaxis to any biologic therapy or vaccine.
- Current active liver disease.
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 |
|---|---|---|
| BenralizumabAlso: FasenraBenralizumab is a humanized, afucosylated, monoclonal antibody that binds specifically to the IL-5Rα on the target cell and thus directly depletes eosinophils through antibody-dependent cell-mediated cytotoxicity. Benralizumab has been widely approved for treatment of asthma. | Biological | Benralizumab |
| PlaceboPlacebo will be injected as a comparator to injection with Benralizumab to examine effect on both the signs and symptoms of EG/EGE and the underlying eosinophilic inflammation, with dual primary outcome variables | Biological | Placebo |
Primary outcome
Proportion of Patients With a Histologic Response at Week 24
Time frame: at week 24
the proportion of patients achieving a histological response at Week 24, is defined as below: * 6 eosinophils/hpf in the stomach for the patients with only gastric disease at baseline. * 6 eosinophils/hpf in the stomach and ≤15 eosinophils/hpf in the duodenum for the patients with gastric + duodenal disease at baseline. * 15 eosinophils/hpf in the duodenum for the patients with only duodenal disease at baseline.
Change From Baseline in SAGED Score at Week 24
Time frame: at week 24
The Symptom Assessment for Gastrointestinal Eosinophilic Diseases (SAGED) instrument was developed to measure gastrointestinal symptoms in participants diagnosed with EG/EGE. It is a daily diary completed by participants each evening from screening until week 76 to record symptoms during the past 24 hours. Severity for each concept is assessed using an 11-point numerical rating scale (0 = 'none' and 10 = 'worst imaginable'). The total SAGED score (range 0-50) is calculated as a 14-day mean of the sum of individual severity items of abdominal pain, nausea, bloating, early satiety and loss of appetite daily. Higher scores indicate greater symptom severity. Three additional items are collected that aren't part of the total SAGED score and are considered separately: severity of vomiting, severity of diarrhoea and frequency of vomiting. Change in SAGED score at week 24 is the week 24 score (study days 155 to 168) minus the baseline score (study days -14 to -1).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 909\_HUDSON\_Poster\_non-US.pdfLink provided by the sponsor.
- 909\_HUDSON\_Poster\_US-enUS.pdfLink provided by the sponsor.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests 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.
Marc E. Rothenberg, MD, PhD principal investigator
Cincinnati Children's Hospital Medical Center 3333 Burnet Ave, Cincinnati Ohio 45229, United States
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benralizumab in people with Eosinophilic Gastritis and Eosinophilic Gastroenteritis, run by AstraZeneca at 20 sites in 9 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Japan, Italy, Brazil, Netherlands and 4 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?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients With a Histologic Response at Week 24 (time frame: at 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 14 Jul 2025.