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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05251909




Registration number
NCT05251909
Ethics application status
Date submitted
6/08/2021
Date registered
23/02/2022
Date last updated
20/02/2024

Titles & IDs
Public title
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
Scientific 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)
Secondary ID [1] 0 0
2021-000085-14
Secondary ID [2] 0 0
D3258C00001
Universal Trial Number (UTN)
Trial acronym
HUDSON GI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Benralizumab
Other interventions - Placebo

Experimental: Benralizumab - This arm is a subcutaneous dose of Benralizumab

Placebo Comparator: Placebo - This arm is a subcutaneous dose of Placebo


Other interventions: Benralizumab
Benralizumab is a humanized, afucosylated, monoclonal antibody that binds specifically to the IL-5Ra on the target cell and thus directly depletes eosinophils through antibody-dependent cell-mediated cytotoxicity. Benralizumab has been widely approved for treatment of asthma.

Other interventions: Placebo
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients achieving a histological response in the stomach and/or in the duodenum
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Percent change in tissue eosinophils
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Proportion achieving treatment response
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Diarrhea-free days
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Frequency of diarrhea episodes
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Vomiting-free days
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Frequency of vomiting episodes
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Proportion of patients with no rescue corticosteroid use
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
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).
Timepoint [8] 0 0
Week 24
Secondary outcome [9] 0 0
Diarrhea and constipation free days
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Clinically meaningful symptom change. Time to clinically meaningful change in SAGED score (range: 0-50) measures gastrointestinal symptoms with higher scores meaning worse outcome.
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
PROMIS Fatigue 7a score
Timepoint [11] 0 0
Week 24
Secondary outcome [12] 0 0
PAGI-QoL score
Timepoint [12] 0 0
Week 24
Secondary outcome [13] 0 0
PAGI-SYM score
Timepoint [13] 0 0
Week 24
Secondary outcome [14] 0 0
Pharmacokinetics of benralizumab in patients (with EG/EGE)
Timepoint [14] 0 0
Minimum 24 weeks
Secondary outcome [15] 0 0
Immunogenicity of benralizumab in patients (with EG/EGE)
Timepoint [15] 0 0
Minimum 24 weeks

Eligibility
Key inclusion 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.
Minimum age
12 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/02/2024
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Italy
State/province [8] 0 0
Milano
Country [9] 0 0
Italy
State/province [9] 0 0
Padova
Country [10] 0 0
Italy
State/province [10] 0 0
Pisa
Country [11] 0 0
Japan
State/province [11] 0 0
Bunkyo-ku
Country [12] 0 0
Japan
State/province [12] 0 0
Maebashi-shi
Country [13] 0 0
Japan
State/province [13] 0 0
Ogaki-shi
Country [14] 0 0
Japan
State/province [14] 0 0
Shinjuku-ku
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Poland
State/province [16] 0 0
Staszów
Country [17] 0 0
Spain
State/province [17] 0 0
Sevilla
Country [18] 0 0
Ukraine
State/province [18] 0 0
Kyiv
Country [19] 0 0
Vietnam
State/province [19] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05251909
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Marc E. Rothenberg, MD, PhD
Address 0 0
Cincinnati Children's Hospital Medical Center 3333 Burnet Ave, Cincinnati Ohio 45229, United States
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05251909