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Monoclonal Antibodies

Benralizumab for Eosinophilic Gastrointestinal Diseases (HUDSON GI Trial)

Phase 3
Waitlist Available
Led By Marc E. Rothenberg, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptoms including at least moderate abdominal pain, nausea, bloating, early satiety, and/or loss of appetite
Baseline Eosinophilic gastritis, with or without duodenitis, or eosinophilic duodenitis alone confirmed by biopsy with specific eosinophil counts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

HUDSON GI Trial Summary

This trial has three parts. The first two are identical, and involve patients with eosinophilic gastritis or duodenal disease. They will be given either a placebo or the drug being tested. The third part is an open-label trial, meaning everyone will receive the drug.

Who is the study for?
This trial is for people aged 12 and older with a confirmed diagnosis of eosinophilic gastritis or gastroenteritis. They must have certain levels of eosinophils in their stomach or duodenum, experience symptoms like abdominal pain and nausea, and be on stable medication if any. Women who can have children must use effective birth control.Check my eligibility
What is being tested?
The study tests Benralizumab against a placebo in patients with eosinophilic gastritis/gastroenteritis. It's divided into three parts: initial randomization (Part A), optional continuation (Part C), and an additional open-label treatment phase (Part D).See study design
What are the potential side effects?
While not specified here, common side effects of drugs like Benralizumab may include headache, sore throat, fever, fatigue, allergic reactions at the injection site, and possible increased risk of infections.

HUDSON GI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience moderate to severe stomach issues, including pain and loss of appetite.
Select...
I have been diagnosed with eosinophilic gastritis or duodenitis through a biopsy.

HUDSON GI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Proportion of patients achieving a histological response in the stomach and/or in the duodenum
Secondary outcome measures
Clinically meaningful symptom change. Time to clinically meaningful change in SAGED score (range: 0-50) measures gastrointestinal symptoms with higher scores meaning worse outcome.
Constipation
Diarrhea-free days
+12 more
Other outcome measures
Safety and tolerability - Incidence of Treatment-Emerged AEs and SAEs

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
16%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo

HUDSON GI Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BenralizumabExperimental Treatment1 Intervention
This arm is a subcutaneous dose of Benralizumab
Group II: PlaceboPlacebo Group1 Intervention
This arm is a subcutaneous dose of Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 3
~10580

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,774 Total Patients Enrolled
Marc E. Rothenberg, MD, PhDPrincipal InvestigatorCincinnati Children's Hospital Medical Center 3333 Burnet Ave, Cincinnati Ohio 45229, United States
2 Previous Clinical Trials
245 Total Patients Enrolled

Media Library

Benralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05251909 — Phase 3
Eosinophilic Gastritis Research Study Groups: Placebo, Benralizumab
Eosinophilic Gastritis Clinical Trial 2023: Benralizumab Highlights & Side Effects. Trial Name: NCT05251909 — Phase 3
Benralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05251909 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other research institutions conducting this trial in North America?

"Currently, there are 18 sites conducting this trial. If you enroll, try and choose a location close to you from the list of Park Ridge, Rochester, Chapel Hill or the other 15 locations to reduce travel time."

Answered by AI

Has Benralizumab been cleared by the FDA?

"Benralizumab's safety was rated a 3 by our team at Power. This is due to the fact that this is a phase 3 trial, and thus there exists both some data supporting efficacy as well as multiple rounds of data reinforcing its safety."

Answered by AI

Is the target age group for this research over 40 years old?

"In order to participate in this trial, patients must be between 12 and 130 years old. There are currently 37 clinical trials underway for individuals under 18 while 53 different trials focus on those over 65."

Answered by AI

Are we still looking for participants in this research project?

"Yes, this particular clinical trial is still recruiting patients according to the most recent update on clinicaltrials.gov from November 3rd, 2022. The study was originally posted 18th January, 2020."

Answered by AI

To whom is this research available?

"This study is recruiting 230 patients with eosinophilic gastritis aged 12 and over. The most notable requirements for applicants are as follows: Symptoms including at least moderate abdominal pain, nausea, bloating, early satiety, and/or loss of appetite; 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"

Answered by AI

How many individuals are participating in this experiment?

"That is right, the online information hosted on clinicaltrials.gov confirms that this study is still enrolling patients. The trial was first advertised on 1/18/2022 and received its most recent update 11/3/2022. A total of 230 individuals are needed for the 18 different research sites."

Answered by AI

What are the goals that participants in this trial are hoping to achieve?

"The purpose of this trial is to determine the efficacy of the medication over a 24-week period, specifically in regards to histological response rates in patients with stomach or duodenal conditions. Additionally, the study will also measure clinically meaningful symptom improvement, PROMIS fatigue 7a score, and diarrhea/constipation free days as secondary outcomes."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
2022. "Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05251909.
~4 spots leftby Apr 2025
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