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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000085-14 | EudraCT Number |
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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benralizumab | Experimental | This arm is a subcutaneous dose of Benralizumab |
|
| Placebo | Placebo Comparator | This arm is a subcutaneous dose of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benralizumab | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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). | at week 24 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc E. Rothenberg, MD, PhD | Cincinnati Children's Hospital Medical Center 3333 Burnet Ave, Cincinnati Ohio 45229, United States | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chicago | Illinois | 60611 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| 909\_HUDSON\_Poster\_non-US.pdf | View source |
| 909\_HUDSON\_Poster\_US-enUS.pdf | View source |
Not provided
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.
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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de- identified individual patient-level data in an approved sponsor 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
All participants complete a 4-week to 8-week run-in period during which inclusion/exclusion criteria was assessed.
A total of 34 participants were screened. Of those, 12 participants were randomised to either the treatment (6 participants) or placebo (participants) arms of the double-blinded treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Benralizumab | Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period |
| FG001 | Placebo | Patients received matching Placebo every 4 weeks for the 24 weeks treatment period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2023 | Jun 26, 2025 |
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This is a parallel-group efficacy and safety study with 2 arms that are participant and investigator blinded, with an open-label extension.
|
|
| Placebo | Biological | 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 |
|
| Boston |
| Massachusetts |
| 02111 |
| United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | Chapel Hill | North Carolina | 27599 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Salt Lake City | Utah | 84107 | United States |
| Research Site | Salt Lake City | Utah | 84132 | United States |
| Research Site | São Paulo | 01327-001 | Brazil |
| Research Site | Milan | 20122 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Pisa | 56124 | Italy |
| Research Site | Bunkyō City | 113-8603 | Japan |
| Research Site | Maebashi | 371-8511 | Japan |
| Research Site | Ogaki-shi | 503-8502 | Japan |
| Research Site | Shinjuku-ku | 162-8655 | Japan |
| Research Site | Amsterdam | 1105 AZ | Netherlands |
| Research Site | Staszów | 28-200 | Poland |
| Research Site | Seville | 41009 | Spain |
| Research Site | Kyiv | 04050 | Ukraine |
| Research Site | Hanoi | 100000 | Vietnam |
| CSR Synopsis | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
| Open Label Extension |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Benralizumab | Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period |
| BG001 | Placebo | Patients received matching Placebo every 4 weeks for the 24 weeks treatment period |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Count of Participants | Participants | at week 24 |
|
|
| ||||||||||||||||||||||||||||||
| Primary | 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). | Posted | Mean | Standard Error | score | at week 24 |
|
AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period.
Placebo= All patients received matching Placebo every 4 weeks in the double-blind period.
Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Benralizumab | Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period | 0 | 6 | 0 | 6 | 6 | 6 |
| EG001 | Placebo | Patients received matching Placebo every 4 weeks for the 24 weeks treatment period | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Open Label Benralizumab | Patients received benralizumab 30mg every 4 weeks during the open-label extension period. | 0 | 9 | 0 | 9 | 6 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Genitourinary tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Menstrual discomfort | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Myopic chorioretinal degeneration | Eye disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
Due to early termination of study limited numbers of patients was randomized and thus data not analysed on group level.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_008.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2023 | Jun 26, 2025 | SAP_009.pdf |
Not provided
| ID | Term |
|---|---|
| C535952 | Eosinophilic enteropathy |
| D005759 | Gastroenteritis |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C571386 | benralizumab |
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| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|