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Sphingosine 1-phosphate receptor modulator
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With 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
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 • NCT0470679314%
Headache
11%
Malaise
11%
Pyrexia
7%
Colitis ulcerative
7%
Vaccination site pain
4%
Back pain
4%
COVID-19
4%
Contusion
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
5,694 Total Patients Enrolled
Arena is a wholly owned subsidiary of PfizerUNKNOWN
10 Previous Clinical Trials
2,463 Total Patients Enrolled
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,073 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,929 Total Patients Enrolled
Arena CT.gov AdministratorStudy DirectorArena Pharmaceuticals
21 Previous Clinical Trials
4,700 Total Patients Enrolled