What side effects are associated with this type of intervention?

Common treatments for Eosinophilic Esophagitis (EoE) include monoclonal antibodies, corticosteroids, and dietary management. Monoclonal antibodies, like those studied in the CC-93538 trial, generally have side effects such as injection site reactions, nasopharyngitis, and headache. Corticosteroids, often used topically or systemically, can cause oral thrush, adrenal suppression, and growth retardation in children. Dietary management, which involves eliminating specific allergens, may lead to nutritional deficiencies if not properly supervised. Overall, these treatments are generally well-tolerated but require monitoring for potential adverse effects.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for Eosinophilic Esophagitis (EoE). However, treatments under investigation, such as the monoclonal antibody CC-93538, aim to address the underlying allergic inflammation associated with EoE. Similar biologic treatments, like dupilumab, which targets interleukin pathways involved in allergic responses, are being studied for their efficacy and safety in managing EoE symptoms.

What other types of research exist?

Promising novel alternatives to CC-93538 for Eosinophilic Esophagitis patients include biologics such as Dupilumab and JAK inhibitors like Upadacitinib. Dupilumab, an IL-4 receptor alpha antagonist, has shown efficacy in reducing eosinophil counts and improving symptoms in EoE patients. Upadacitinib, a selective JAK inhibitor, has demonstrated significant improvements in inflammatory conditions and may offer benefits for EoE. Both therapies are in advanced stages of clinical development and have shown favorable safety profiles.

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CC-93538 for Eosinophilic Esophagitis

Phase 3

Recruiting

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR

Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR

Must not have

Active Helicobacter pylori infection or esophageal varices.

Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for a minimum of 28 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to evaluate the ongoing safety and tolerability of CC-93538 in participants who were part of earlier studies involving this treatment.

Who is the study for?

This trial is for adults and adolescents who have Eosinophilic Esophagitis (EoE) and were part of previous CC-93538 studies. They must not have other conditions that could affect the study, no severe allergies to ingredients in CC-93538, no recent immunotherapy or live vaccines, and women must test negative for pregnancy and use contraception.

What is being tested?

The trial tests the long-term safety of a drug called CC-93538 in patients with EoE who participated in earlier related trials. It's an open-label study, meaning everyone knows they're getting the drug, without a comparison group.

What are the potential side effects?

While specific side effects are not listed here, participants from prior studies are excluded if they had clinically significant adverse events to CC-93538 that would prevent further dosing.

Eligibility Criteria

Inclusion Criteria

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

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I had a severe EoE flare-up needing urgent treatment and finished 24 weeks of the initial treatment phase.

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I had a severe EoE flare needing endoscopy or extra treatment and finished Week 48 of the maintenance phase.

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I have completed 48 weeks of the maintenance phase.

Exclusion Criteria

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

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I have an active Helicobacter pylori infection or esophageal varices.

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I have not taken any immune-weakening drugs recently.

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I haven't taken oral or sublingual immunotherapy in the last 6 months.

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I do not have any health conditions that could interfere with the study or increase my risk by participating.

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I do not have any active or suspected parasitic infections or chronic infections like hepatitis, tuberculosis, or HIV.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for a minimum of 28 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for a minimum of 28 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and for a minimum of 28 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Adverse Events (AEs)

Secondary study objectives

Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies

Side effects data

From 2022 Phase 2 trial • 221 Patients • NCT04800315

37%

Dermatitis atopic

COVID-19

Upper respiratory tract infection

Conjunctivitis allergic

Folliculitis

Alanine aminotransferase increased

Blood creatine phosphokinase increased

Fatigue

Back pain

Headache

Nasopharyngitis

Deep vein thrombosis

Cellulitis

Respiratory tract infection

Pulmonary hypertension

Injection site erythema

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Treatment 1

Treatment 2

Treatment 3

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of CC-93538Experimental Treatment1 Intervention

Participants are administered CC-93538 dose subcutaneously once weekly

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-93538

2021

Completed Phase 2

~330

0 / 9Eligibility 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) include proton pump inhibitors (PPIs), topical corticosteroids, and biologic agents. PPIs reduce acid production, which can help decrease inflammation and eosinophil activity in the esophagus. Topical corticosteroids, such as fluticasone or budesonide, reduce local inflammation by inhibiting the activity of eosinophils and other inflammatory cells. Biologic agents, like the one studied in the CC-93538 trial, typically target specific pathways involved in the inflammatory process, such as interleukin-5 (IL-5) or interleukin-13 (IL-13), which are crucial for eosinophil survival and activity. These treatments are important for EoE patients as they help manage symptoms, reduce inflammation, and prevent long-term esophageal damage.