What is the mechanism of action of this treatment?

Common treatments for Eosinophilic Esophagitis (EoE) primarily focus on reducing inflammation caused by eosinophils in the esophagus. Treatments like EP-104IAR, which are being studied for their anti-inflammatory effects, work by targeting the inflammatory pathways that lead to eosinophil accumulation and activation. This is crucial for EoE patients as it helps to reduce symptoms such as dysphagia (difficulty swallowing) and esophageal pain, thereby improving their quality of life. Other treatments may include corticosteroids, which suppress the immune response, and dietary management to eliminate allergens that trigger eosinophilic activity.

What side effects are associated with this type of intervention?

Common treatments for Eosinophilic Esophagitis (EoE) with anti-inflammatory effects, similar to EP-104IAR, include corticosteroids and biologics. Corticosteroids like fluticasone and budesonide can cause side effects such as oral thrush, adrenal suppression, and esophageal candidiasis. Biologics like dupilumab may lead to injection site reactions, conjunctivitis, and nasopharyngitis. These treatments aim to reduce eosinophilic inflammation in the esophagus.

What prior FDA approvals exist?

The FDA has approved several treatments for Eosinophilic Esophagitis (EoE) that focus on reducing eosinophilic inflammation in the esophagus. One notable example is Dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling, which are key drivers of type 2 inflammation. Another treatment is Fluticasone, a corticosteroid that can be swallowed to reduce local inflammation in the esophagus. These treatments aim to alleviate symptoms by targeting the underlying inflammatory processes, similar to the investigational drug EP-104IAR, which is being studied for its anti-inflammatory effects on eosinophilic inflammation in EoE.

What other types of research exist?

Promising novel alternatives to EP-104IAR for Eosinophilic Esophagitis patients include biologics such as Dupilumab, which targets IL-4 and IL-13 pathways, and JAK inhibitors like Upadacitinib, which modulate immune responses. These treatments have shown efficacy in related inflammatory conditions and may offer new therapeutic options for EoE.

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EP-104IAR for EoE (RESOLVE Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Eupraxia Pharmaceuticals Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, EP-104IAR, in adults with eosinophilic esophagitis (EoE). The drug is given during an endoscopy to see if it can reduce inflammation and symptoms in the esophagus.

Who is the study for?

Adults with eosinophilic esophagitis (EoE) who can consent and follow the study plan. Women must test negative for pregnancy and use birth control. Excluded are those with other esophageal diseases, infections, severe swallowing disorders, risks from endoscopy or biopsy procedures, recent steroid contraindications, certain medication use, dietary changes or another trial participation.

What is being tested?

The safety and effects of varying doses of EP-104IAR in adults with EoE are being tested. Up to 24 participants will receive the drug during an endoscopic procedure over about 32 weeks. The study includes blood/urine tests for safety monitoring and questionnaires on swallowing difficulties.

What are the potential side effects?

While specific side effects aren't listed here, the trial monitors for adverse reactions through regular blood and urine tests after administering EP-104IAR via endoscopy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 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

Change from baseline in clinical safety laboratory measurements

Change from baseline in morning serum cortisol levels

Change from baseline in vital signs and physical examination results

+3 more

Secondary study objectives

Change from baseline in EoE Histology Scoring System (EoEHSS) score

Deglutition Disorders

Change from baseline in odynophagia measured on an 11 point Likert scale

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

9Treatment groups

Experimental Treatment

Group I: EP-104IAR 96 mgExperimental Treatment1 Intervention

16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Group II: EP-104IAR 8 mgExperimental Treatment1 Intervention

8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Group III: EP-104IAR 72 mgExperimental Treatment1 Intervention

12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Group IV: EP-104IAR 64 mgExperimental Treatment1 Intervention

16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Group V: EP-104IAR 48 mgExperimental Treatment1 Intervention

12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Group VI: EP-104IAR 4 mgExperimental Treatment1 Intervention

4 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Group VII: EP-104IAR 30 mgExperimental Treatment1 Intervention

12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Group VIII: EP-104IAR 20 mgExperimental Treatment1 Intervention

8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Group IX: EP-104IAR 120 mgExperimental Treatment1 Intervention

20 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EP-104IAR

2016

Completed Phase 1

~40

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) primarily focus on reducing inflammation caused by eosinophils in the esophagus. Treatments like EP-104IAR, which are being studied for their anti-inflammatory effects, work by targeting the inflammatory pathways that lead to eosinophil accumulation and activation. This is crucial for EoE patients as it helps to reduce symptoms such as dysphagia (difficulty swallowing) and esophageal pain, thereby improving their quality of life. Other treatments may include corticosteroids, which suppress the immune response, and dietary management to eliminate allergens that trigger eosinophilic activity.