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Monoclonal Antibodies

Dupilumab for Eosinophilic Esophagitis

Phase 4

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Participants must be diagnosed with PPI resistant eosinophilic esophagitis (EoE) proven by endoscopic biopsy showing > 15 eosinophils/HPF prior to and 8 weeks after treatment with PPI

Eligible participants must not have taken inhalational, oral or IV steroids for at least 8 weeks prior to the study

Must not have

Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections

Treatment with a live (attenuated) vaccine within 4 weeks prior to the baseline visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline assesment at 2 weeks to the end of the study at 14 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to see if Dupilumab, a drug approved by the FDA, can improve muscle activity in the esophagus of patients with Eosinophilic esophagitis (

Who is the study for?

This trial is for patients with Eosinophilic Esophagitis (EoE), a condition where the esophagus becomes inflamed due to allergies. Participants should have muscle dysfunction in their esophagus, affecting food movement. The study excludes details on specific inclusion and exclusion criteria.

What is being tested?

The study tests Dupilumab, an FDA-approved drug for allergic inflammation, to see if it improves the muscle function of the esophagus in EoE patients. Participants will take Dupilumab weekly for 12 weeks and monitor symptoms in a diary.

What are the potential side effects?

While not specified here, common side effects of Dupilumab may include injection site reactions, eye problems like dryness or irritation, cold sores due to herpes virus activation, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have EoE that didn't improve after 8 weeks of PPI treatment.

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I haven't taken any steroids by mouth, inhalation, or IV for the last 8 weeks.

Exclusion Criteria

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

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I have a history of severe infections due to a weak immune system.

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I have not received a live vaccine in the last 4 weeks.

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I have been diagnosed with hepatitis C.

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I am a woman able to have children but do not use effective birth control.

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I have previously participated in a Dupilumab trial or have been treated with Dupilumab.

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I have been diagnosed with HIV.

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I have been diagnosed with hepatitis B.

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I have an active stomach infection or a history of specific digestive conditions.

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I have a health condition that prevents me from taking Dupilumab for EOE.

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I am expecting to undergo a major surgery during the study.

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I do not have an active or suspected parasitic infection, or it has been ruled out.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline assesment at 2 weeks to the end of treatment at 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline assesment at 2 weeks to the end of treatment at 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline assesment at 2 weeks to the end of treatment at 14 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To determine the change in the peak esophageal muscle thickness during peristalsis following 12 weeks of Dupilumab

Secondary study objectives

To determine the change in the esophageal luminal cross-sectional area ( measured in mm2) following treatment with Dupilumab

To determine the differences in amplitude of longitudinal muscle contraction in EOE participants who have reduction in eosinophil count < 6 HPF, compared to the one with eosinophil count > 6HPF following 12 weeks treatment with Dupilumab

To determine the differences in the luminal CSA during peristalsis following 12 weeks of treatment with Dupilumab in EOE participants who have reduction in the eosinophil count of < 6 HPF as compared to the one with eosinophil count of > 6HPF.

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

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

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: EoE participants treated with DupilumabExperimental Treatment1 Intervention

All the participants will be treated with once a week subcutaneous injection of Dupilumab 300 mg through for 12 weeks. There is no placebo arm in the study.

0 / 13Eligibility criteria met