Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

NCT05251909 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: D3258C000012021-000085-14
• Study Type: interventional
• Target: 12
• Locations: 9 countries
• Sites: 20

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.

Conditions

Eosinophilic Gastritis; Eosinophilic Gastroenteritis

Keywords

Benralizumab; Eosinophilic Gastritis; Gastroenteritis; Intestinal Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  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

Study Arms (2)

Benralizumab

EXPERIMENTAL

This arm is a subcutaneous dose of Benralizumab

Biological: Benralizumab

Placebo

PLACEBO COMPARATOR

This arm is a subcutaneous dose of Placebo

Biological: Placebo

Interventions

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.

Also known as: Fasenra

Benralizumab

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

Placebo

Eligibility Criteria

• Age: 12 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (20)

Research Site

Chicago, Illinois, 60611, United States

Location

Research Site

Boston, Massachusetts, 02111, United States

Location

Research Site

Rochester, Minnesota, 55905, United States

Location

Research Site

Chapel Hill, North Carolina, 27599, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Salt Lake City, Utah, 84107, United States

Location

Research Site

Salt Lake City, Utah, 84132, United States

Location

Research Site

São Paulo, 01327-001, Brazil

Location

Research Site

Milan, 20122, Italy

Location

Research Site

Padua, 35128, Italy

Location

Research Site

Pisa, 56124, Italy

Location

Research Site

Bunkyō City, 113-8603, Japan

Location

Research Site

Maebashi, 371-8511, Japan

Location

Research Site

Ogaki-shi, 503-8502, Japan

Location

Research Site

Shinjuku-ku, 162-8655, Japan

Location

Research Site

Amsterdam, 1105 AZ, Netherlands

Location

Research Site

Staszów, 28-200, Poland

Location

Research Site

Seville, 41009, Spain

Location

Research Site

Kyiv, 04050, Ukraine

Location

Research Site

Hanoi, 100000, Vietnam

Location

Related Links

• 909\_HUDSON\_Poster\_non-US.pdf
• 909\_HUDSON\_Poster\_US-enUS.pdf
• CSR Synopsis

MeSH Terms

Conditions

Eosinophilic enteropathy; Gastroenteritis; Intestinal Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Interventions

benralizumab

Limitations and Caveats

Due to early termination of study limited numbers of patients was randomized and thus data not analysed on group level.

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Marc E. Rothenberg, MD, PhD

  Cincinnati Children's Hospital Medical Center 3333 Burnet Ave, Cincinnati Ohio 45229, United States

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a parallel-group efficacy and safety study with 2 arms that are participant and investigator blinded, with an open-label extension.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: February 23, 2022
• Study Start: January 18, 2022
• Primary Completion: February 13, 2024
• Study Completion: February 13, 2024
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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
• 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

Locations

IT (3); BR (1); PL (1); JP (4); VN (1); US (7); NL (1); ES (1); UA (1)