What side effects are associated with this type of intervention?

Common treatments for Eosinophilic Esophagitis (EoE) include proton pump inhibitors (PPIs), topical corticosteroids, and dietary management. PPIs can cause side effects such as headache, diarrhea, and abdominal pain. Topical corticosteroids, like fluticasone and budesonide, may lead to oral thrush and, less commonly, adrenal suppression. Dietary management primarily involves elimination diets, which can be challenging to maintain and may lead to nutritional deficiencies if not properly managed. For treatments similar to Tezepelumab, which targets TSLP, potential side effects could include injection site reactions, hypersensitivity reactions, and possibly an increased risk of infections, although specific data on Tezepelumab's side effects in EoE patients is still being studied.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically targeting thymic stromal lymphopoietin (TSLP) for Eosinophilic Esophagitis (EoE). However, biologic treatments such as Dupilumab, which targets the IL-4 receptor alpha subunit and inhibits IL-4 and IL-13 signaling, have shown efficacy in clinical trials for EoE. Other treatments under investigation include monoclonal antibodies targeting IL-5, such as Mepolizumab, which have been used for related eosinophilic conditions like severe asthma. These treatments represent a growing interest in biologic therapies for EoE, focusing on modulating the immune response.

What other types of research exist?

Promising novel alternatives to Tezepelumab for Eosinophilic Esophagitis patients include Dupilumab, an anti-IL-4 receptor alpha monoclonal antibody that inhibits IL-4 and IL-13 signaling, which are key cytokines involved in type 2 helper T cell (Th2) responses. Additionally, anti-IgE therapies like Omalizumab and Ligelizumab, which have shown efficacy in related allergic conditions, may also be considered.

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Monoclonal Antibodies

Tezepelumab for Eosinophilic Esophagitis (CROSSING Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 0, 4, 12, 24, and 52

Awards & highlights

Pivotal Trial

Summary

This trial tests an injection treatment for people with a condition that causes swelling in the esophagus. The treatment aims to reduce this swelling by calming the immune system.

Who is the study for?

Adults and adolescents aged 12-80 with a confirmed diagnosis of EoE, weighing at least 40 kg, experiencing swallowing difficulties at least twice weekly. Participants must have been on a stable diet and any acid reflux or allergy medications for 8 weeks before the trial starts.

What is being tested?

The study is testing Tezepelumab, given by injection using a pre-filled syringe, against a placebo to see if it's effective and safe in treating eosinophilic esophagitis (EoE). It's randomized and double-blind so neither doctors nor patients know who gets the real treatment.

What are the potential side effects?

Possible side effects of Tezepelumab are not detailed here but could include reactions at the injection site, allergic responses, or other immune-related issues as commonly seen with monoclonal antibody therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 4, 12, 24, and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 0, 4, 12, 24, and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 4, 12, 24, and 52 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Deglutition Disorders

Change from baseline in EoE EREFS (Endoscopic reference score )

Eosinophil

+1 more

Other study objectives

Anti-drug antibody

Change from baseline in EoE-HSS (Histologic scoring system) grade score

Change from baseline in EoE-HSS (Histologic scoring system) stage score

+3 more

Side effects data

From 2020 Phase 3 trial • 150 Patients • NCT03406078

16%

Nasopharyngitis

12%

Upper respiratory tract infection

Bronchitis bacterial

Asthma

Bronchitis

Oral candidiasis

Myalgia

Headache

Fall

Hypertension

Sinusitis

Cardiac arrest

Cardiac failure

Supraventricular tachycardia

Septic shock

Incisional hernia

Acute kidney injury

Inguinal hernia

Intervertebral discitis

Pneumonia

Arthralgia

Invasive breast carcinoma

Nephrolithiasis

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Tezepelumab

Placebo

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Tezepelumab Low DoseExperimental Treatment1 Intervention

Tezepelumab subcutaneous injections, in accessorised pre-filled syringes

Group II: Tezepelumab High DoseExperimental Treatment1 Intervention

Tezepelumab subcutaneous injections, in accessorised pre-filled syringes

Group III: PlaceboPlacebo Group1 Intervention

Placebo subcutaneous injections, in accessorised pre-filled syringes

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tezepelumab

2018

Completed Phase 3

~2430

Do I qualify?Apply below to find out

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

Common treatments for Eosinophilic Esophagitis (EoE) include dietary management, proton pump inhibitors (PPIs), topical corticosteroids, and biologic therapies. Dietary management involves eliminating specific allergens that trigger EoE. PPIs reduce acid production, which can help decrease inflammation. Topical corticosteroids, such as fluticasone or budesonide, reduce local inflammation in the esophagus. Biologic therapies, like Tezepelumab, target specific immune pathways; Tezepelumab inhibits thymic stromal lymphopoietin (TSLP), a cytokine involved in the inflammatory response. This inhibition is crucial for EoE patients as it can reduce eosinophil activation and inflammation, leading to symptom relief and improved esophageal function.