What is the mechanism of action of this treatment?

The most common treatments for Eosinophilic Gastritis, such as benralizumab, work by targeting and depleting eosinophils, which are white blood cells involved in inflammatory responses. Benralizumab is an anti-eosinophil monoclonal antibody that binds to the IL-5 receptor on eosinophils, leading to their destruction. This mechanism is crucial for patients with Eosinophilic Gastritis because eosinophils contribute to the inflammation and tissue damage characteristic of the disease. By reducing eosinophil levels, these treatments can alleviate symptoms and improve the quality of life for patients.

What side effects are associated with this type of intervention?

Benralizumab, an anti-eosinophil monoclonal antibody, is generally well-tolerated but can have side effects such as headache, pharyngitis, and injection site reactions. Other treatments for eosinophilic gastritis, like corticosteroids, can cause side effects including weight gain, hypertension, and increased risk of infections. Anti-IgE treatments, used in similar contexts, may lead to allergic reactions, including rash and anaphylaxis, and gastrointestinal symptoms. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Eosinophilic Gastritis. However, biologic treatments similar to Benralizumab, such as other anti-eosinophil monoclonal antibodies, are being studied. Benralizumab itself is under investigation for its efficacy and safety in treating Eosinophilic Gastritis, as seen in the HUDSON GI Study. Other related drugs that target eosinophils, like Mepolizumab and Reslizumab, are approved for conditions like severe eosinophilic asthma but not specifically for Eosinophilic Gastritis.

What other types of research exist?

Promising novel alternatives to Benralizumab for Eosinophilic Gastritis patients in 2024 may include other biologics targeting eosinophils or related pathways, such as Dupilumab (an IL-4 receptor alpha antagonist) and Mepolizumab (an IL-5 antagonist). Additionally, emerging therapies targeting B-cells or regulatory T-cell modulation, such as Ocrelizumab or low-dose IL-2 therapy, may also be considered.

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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

Must not have

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

Concomitant use of immunosuppressive medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Pivotal Trial

Summary

This trial involves using benralizumab to treat patients with inflammation in their stomach or upper small intestine. The medication works by lowering the number of specific cells that cause this inflammation. Patients who participate can receive this treatment for several months.

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.

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).

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience moderate to severe stomach issues, including pain and loss of appetite.

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I have been diagnosed with eosinophilic gastritis or duodenitis through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was diagnosed with a worm infection in the last 24 weeks and treatment didn’t work or I haven’t been treated.

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I am currently taking medication that suppresses my immune system.

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I have been diagnosed with a rare blood disorder or a specific type of vasculitis.

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I have an ongoing liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

Safety and tolerability - Incidence of Treatment-Emerged AEs and SAEs

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255

15%

Nasopharyngitis

Asthma

Sinusitis

Headache

Bronchitis

Upper respiratory tract infection

Influenza

Back pain

Cough

Dyspnoea

Hypertension

Rhinitis

Urosepsis

Nephrolithiasis

Intervertebral disc protrusion

Umbilical hernia

Adverse drug reaction

Hypersensitivity

Vertigo

Nausea

Dermatitis atopic

Urinary tract infection bacterial

100%

80%

60%

40%

20%

Study treatment Arm

Benra 30 mg q.4 Weeks

Benra 30 mg q.8 Weeks

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 4

~10320

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Eosinophilic Gastritis, such as benralizumab, work by targeting and depleting eosinophils, which are white blood cells involved in inflammatory responses. Benralizumab is an anti-eosinophil monoclonal antibody that binds to the IL-5 receptor on eosinophils, leading to their destruction. This mechanism is crucial for patients with Eosinophilic Gastritis because eosinophils contribute to the inflammation and tissue damage characteristic of the disease. By reducing eosinophil levels, these treatments can alleviate symptoms and improve the quality of life for patients.

Efficacy and Safety of Anti-Interleukin-5 Therapies in Chronic Rhinosinusitis with Nasal Polyps: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.World Health Organization-defined eosinophilic disorders: 2019 update on diagnosis, risk stratification, and management.