What side effects are associated with this type of intervention?

Common treatments for Eosinophilic Esophagitis (EoE) include dietary management, proton pump inhibitors (PPIs), topical corticosteroids, and monoclonal antibodies targeting specific immune pathways. Known side effects of PPIs can include headache, diarrhea, and abdominal pain. Topical corticosteroids may cause oral thrush and, less commonly, adrenal suppression. Monoclonal antibodies, such as those targeting IL-5 or IL-5 receptors, can lead to injection site reactions, headache, and increased risk of infections. Specific to Barzolvolimab, while detailed side effect data may not be available, it is likely to share similar risks as other monoclonal antibodies, including potential allergic reactions and immunosuppression.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Eosinophilic Esophagitis that target the IL-5 receptor. However, reslizumab, a monoclonal antibody targeting IL-5, has been studied for EoE and showed significant reductions in esophageal eosinophil counts. Other biologics like dupilumab, which targets the IL-4 receptor alpha subunit, have shown promise in clinical trials for EoE but are not yet FDA-approved for this specific condition.

What other types of research exist?

Promising novel alternatives to Barzolvolimab for Eosinophilic Esophagitis patients include Dupilumab (an IL-4 receptor alpha antagonist) and Benralizumab (an IL-5 receptor alpha-directed cytolytic monoclonal antibody). Both have shown potential in reducing eosinophil levels and improving clinical symptoms in EoE patients.

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Monoclonal Antibodies

Barzolvolimab for Eosinophilic Esophagitis (EvolvE Trial)

Verified Trial

Phase 2

Recruiting

Research Sponsored by Celldex Therapeutics

Eligibility Criteria Checklist

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

Must have

≥ 18 years of age

On a stable diet which includes solid foods for ≥ 2 months prior to Screening (and throughout the study)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose through visit 14 (week 44)

Summary

This trial is testing a medication called barzolvolimab. It aims to help adult patients with Eosinophilic Esophagitis, a condition affecting the esophagus. The study will check if barzolvolimab can reduce inflammation and improve symptoms.

Who is the study for?

Adults with Eosinophilic Esophagitis who experience swallowing difficulties at least twice a week, have not responded well to standard treatments, and can complete daily questionnaires. They must not have certain other digestive or allergic conditions, recent esophageal procedures, or be on specific medications.

What is being tested?

The trial is testing the effectiveness and safety of barzolvolimab compared to a placebo in treating adults with Eosinophilic Esophagitis. Participants will receive either the actual drug or a placebo without knowing which one they are getting.

What are the potential side effects?

Potential side effects of barzolvolimab may include allergic reactions similar to those experienced with other biologic therapies. Specific side effects for this drug are not listed but could align with common infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

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Standard treatments for my EoE did not work or were not suitable for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose through visit 14 (week 44)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose through visit 14 (week 44)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose through visit 14 (week 44) 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 to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).

Secondary study objectives

Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf).

Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC ≥ 12/hpf.

Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ).

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Barzolvolimab (CDX-0159)Active Control1 Intervention

300 mg subcutaneous administration every 4 weeks through week 24

Group II: Placebo then barzolvolimab (CDX-0159) 300mgPlacebo Group1 Intervention

Matching placebo subcutaneous administration every 4 weeks through week 16, then 300mg subcutaneous administration every 4 weeks through week 24

0 / 4Eligibility 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

Common treatments for Eosinophilic Esophagitis (EoE) often involve monoclonal antibodies that target specific pathways to reduce eosinophilic activity. Barzolvolimab, for example, targets the IL-5 receptor, crucial for eosinophil activation and survival. By inhibiting this receptor, barzolvolimab reduces eosinophil numbers, thereby decreasing inflammation and alleviating symptoms. Similar treatments include anti-IL-5 (e.g., mepolizumab) and anti-IL-4/IL-13 (e.g., dupilumab), which also aim to reduce eosinophilic activity and inflammation. These targeted therapies are essential for effectively managing EoE by addressing the underlying cause of inflammation.