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Sphingosine 1-phosphate receptor modulator

Etrasimod for Eosinophilic Esophagitis (VOYAGE Trial)

Phase 2

Waitlist Available

Research Sponsored by Arena Pharmaceuticals

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 baseline up to week 24

Summary

This trial is testing whether a pill called etrasimod can safely and effectively treat adults with active eosinophilic esophagitis, a condition where the esophagus gets inflamed due to certain white blood cells. Etrasimod aims to reduce this inflammation by calming down the immune system.

Eligible Conditions

Eosinophilic Esophagitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16

Secondary study objectives

Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16

Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16

Other study objectives

Number of Participants With Serious TEAEs, TEAEs Leading to Study Treatment Discontinuation, TEAEs Leading to Death and TEAEs of Special Interest During 24 Week Double Blind Treatment Period

Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period

Side effects data

From 2022 Phase 3 trial • 42 Patients • NCT04706793

14%

Headache

11%

Malaise

11%

Pyrexia

Colitis ulcerative

Vaccination site pain

Back pain

COVID-19

Contusion

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Comparator: Placebo

Experimental: Etrasimod 2 mg

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Etrasimod Dose 2Experimental Treatment1 Intervention

Group II: Etrasimod Dose 1Experimental Treatment1 Intervention

Group III: Placebo and EtrasimodPlacebo Group2 Interventions

Participants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etrasimod

2020

Completed Phase 3

~1580

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