Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) (HUDSON GI)
Primary Purpose
Eosinophilic Gastritis, Eosinophilic Gastroenteritis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Benralizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Gastritis focused on measuring Benralizumab, Eosinophilic Gastritis, Gastroenteritis, Intestinal Diseases, Stomach Diseases, Gastrointestinal Diseases, Digestive System Diseases
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- 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 Week 52.
- Currently pregnant or breast-feeding.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Benralizumab
Placebo
Arm Description
This arm is a subcutaneous dose of Benralizumab
This arm is a subcutaneous dose of Placebo
Outcomes
Primary Outcome Measures
Proportion of patients achieving a histological response in the stomach and/or in the duodenum
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Absolute change from baseline in SAGED (Symptom Assessment for Gastrointestinal Eosinophilic Diseases) Score (range: 0-50). SAGED score measures gastrointestinal symptoms with higher scores meaning worse outcome
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Secondary Outcome Measures
Percent change in tissue eosinophils
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Proportion achieving treatment response
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Diarrhea-free days
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Frequency of diarrhea episodes
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Vomiting-free days
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Frequency of vomiting episodes
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Proportion of patients with no rescue corticosteroid use
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Health-related quality of life measured as change from baseline in SF-36v2 (the Short Form 36-item Health Survey, Version 2) which has two components: Physical Component Summary (PCS) and Mental Component Summary (MCS).
The score range for PCS and MCS is 0-100; higher scores indicate better health state.
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Diarrhea and constipation free days
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Clinically meaningful symptom change. Time to clinically meaningful change in SAGED score (range: 0-50) measures gastrointestinal symptoms with higher scores meaning worse outcome.
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
PROMIS Fatigue 7a score
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
PAGI-QoL score
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
PAGI-SYM score
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Pharmacokinetics of benralizumab in patients (with EG/EGE)
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Immunogenicity of benralizumab in patients (with EG/EGE)
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05251909
Brief Title
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
Acronym
HUDSON GI
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Gastritis, Eosinophilic Gastroenteritis
Keywords
Benralizumab, Eosinophilic Gastritis, Gastroenteritis, Intestinal Diseases, Stomach Diseases, Gastrointestinal Diseases, Digestive System Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
This is a parallel-group efficacy and safety study with 2 arms that are participant and investigator blinded, with an open-label extension.
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Benralizumab
Arm Type
Experimental
Arm Description
This arm is a subcutaneous dose of Benralizumab
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This arm is a subcutaneous dose of Placebo
Intervention Type
Biological
Intervention Name(s)
Benralizumab
Other Intervention Name(s)
Fasenra
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of patients achieving a histological response in the stomach and/or in the duodenum
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Absolute change from baseline in SAGED (Symptom Assessment for Gastrointestinal Eosinophilic Diseases) Score (range: 0-50). SAGED score measures gastrointestinal symptoms with higher scores meaning worse outcome
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percent change in tissue eosinophils
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Proportion achieving treatment response
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Diarrhea-free days
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Frequency of diarrhea episodes
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Vomiting-free days
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Frequency of vomiting episodes
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Proportion of patients with no rescue corticosteroid use
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Health-related quality of life measured as change from baseline in SF-36v2 (the Short Form 36-item Health Survey, Version 2) which has two components: Physical Component Summary (PCS) and Mental Component Summary (MCS).
Description
The score range for PCS and MCS is 0-100; higher scores indicate better health state.
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Diarrhea and constipation free days
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Clinically meaningful symptom change. Time to clinically meaningful change in SAGED score (range: 0-50) measures gastrointestinal symptoms with higher scores meaning worse outcome.
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
PROMIS Fatigue 7a score
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
PAGI-QoL score
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
PAGI-SYM score
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Week 24
Title
Pharmacokinetics of benralizumab in patients (with EG/EGE)
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Minimum 24 weeks
Title
Immunogenicity of benralizumab in patients (with EG/EGE)
Description
Given the decision to stop recruitment to the study, it will not be possible to assess objectives with the data collected during Part A.
Time Frame
Minimum 24 weeks
Other Pre-specified Outcome Measures:
Title
Safety and tolerability - Incidence of Treatment-Emerged AEs and SAEs
Description
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc E. Rothenberg, MD, PhD
Organizational Affiliation
Cincinnati Children's Hospital Medical Center 3333 Burnet Ave, Cincinnati Ohio 45229, United States
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Research Site
City
Maebashi-shi
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Research Site
City
Ogaki-shi
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Research Site
City
Staszów
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
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
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3258C00001&attachmentIdentifier=04cf3d75-047c-4d62-bcdb-c5fe56049f0a&fileName=909_HUDSON_Poster_non-US.pdf&versionIdentifier=
Description
909_HUDSON_Poster_non-US.pdf
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3258C00001&attachmentIdentifier=1cb3d679-cf8b-4fd8-9ffa-03db35818d6f&fileName=909_HUDSON_Poster_US-enUS.pdf&versionIdentifier=
Description
909_HUDSON_Poster_US-enUS.pdf
Learn more about this trial
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
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