What side effects are associated with this type of intervention?

Common treatments for Eosinophilic Esophagitis (EoE) include biologics like cendakimab, which are designed to modulate immune responses. Known side effects of biologics can include injection site reactions (e.g., erythema, pain, or bruising), hypersensitivity reactions (e.g., rash, pruritus, urticaria), and, rarely, serious allergic reactions. Other systemic therapies for EoE, such as corticosteroids, may cause side effects like immunosuppression, increased risk of infections, and potential impacts on metabolic enzymes. 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, the FDA has approved Dupilumab for the treatment of Eosinophilic Esophagitis. Dupilumab is a monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are key drivers of the inflammatory response in EoE. This is somewhat similar to Cendakimab, which is also a monoclonal antibody but targets interleukin-13 (IL-13) specifically. Both drugs aim to reduce inflammation by modulating immune pathways, although their exact mechanisms and targets differ slightly.

What other types of research exist?

Currently, there are no specific novel alternatives to Cendakimab mentioned in the provided context for Eosinophilic Esophagitis. However, patients should discuss with their healthcare provider about ongoing clinical trials and emerging therapies that target metabolic enzymes or other pathways involved in EoE. Other treatment options may include dietary management, proton pump inhibitors, topical corticosteroids, and biologics targeting different inflammatory pathways.

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Monoclonal Antibodies

Cendakimab for Eosinophilic Esophagitis

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

Active Eosinophilic esophagitis (EoE) with histologic evidence as a peak count of ≥ 15 eosinophils per higher-power field at any 2 levels of the esophagus

Previously received an adequate trial of proton-pump inhibitor medication that did not provide complete response to EoE

Must not have

Currently receiving a high potency topical corticosteroid for dermatologic use

On a regimen of therapeutic anticoagulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how a medication called cendakimab interacts with other drugs in people who have a condition affecting the esophagus. The goal is to see if cendakimab changes how these other medications work in the body.

Who is the study for?

This trial is for adults with active Eosinophilic Esophagitis (EoE) who didn't fully respond to proton-pump inhibitors. Participants should have documented symptoms and a certain number of eosinophils in the esophagus. Those using high potency steroids, immunosuppressive drugs, or on anticoagulation therapy cannot join.

What is being tested?

The study is testing how Cendakimab interacts with other drugs metabolized by the body's enzymes in people with EoE. It aims to understand if having EoE changes the way Cendakimab affects these other medications.

What are the potential side effects?

While specific side effects are not listed here, potential side effects may include reactions at the injection site, allergic responses, and any impacts related to changes in drug metabolism due to interactions between Cendakimab and other medications.

Eligibility Criteria

Inclusion Criteria

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

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I have active Eosinophilic esophagitis with a high eosinophil count in my esophagus.

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I tried acid reflux medication for my EoE, but it didn't fully work.

Exclusion Criteria

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

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I am using a strong prescription cream for my skin condition.

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I am currently on blood thinners for treatment.

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I am on drugs that affect my immune system or have evidence of being immunosuppressed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of Cendakimab and Cytochrome P450 (CYP) substratesExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cendakimab

2022

Completed Phase 1

~130

0 / 5Eligibility 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 Esophagitis (EoE) include corticosteroids, dietary management, and biologic therapies such as monoclonal antibodies. Corticosteroids, like fluticasone and budesonide, work by reducing inflammation and eosinophil activity in the esophagus. Dietary management involves eliminating specific allergens that trigger eosinophilic responses. Biologic therapies, such as Cendakimab, target specific pathways involved in the inflammatory process. Cendakimab, for example, modulates metabolic enzymes to reduce eosinophil activation and infiltration in the esophagus. These mechanisms are crucial for EoE patients as they help to alleviate symptoms, prevent esophageal damage, and improve overall quality of life by addressing the underlying inflammatory processes.