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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
Awards & highlights

VOYAGE Trial Summary

This trial will test whether the drug etrasimod is safe and effective for treating adults with active eosinophilic esophagitis.

Eligible Conditions
  • Eosinophilic Esophagitis

VOYAGE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
Secondary outcome measures
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
Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16
+1 more
Other outcome measures
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
7%
Colitis ulcerative
7%
Vaccination site pain
4%
COVID-19
4%
Contusion
4%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Comparator: Placebo
Experimental: Etrasimod 2 mg

VOYAGE 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
~1350

Find a Location

Who is running the clinical trial?

Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
5,768 Total Patients Enrolled
Arena is a wholly owned subsidiary of PfizerUNKNOWN
10 Previous Clinical Trials
2,537 Total Patients Enrolled
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,877 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide a synopsis of the other investigations that have been conducted with Etrasimod?

"Presently, there are 7 active clinical trials assessing the efficacy of Etrasimod with 3 in Phase 3. These medical studies span 1131 locations worldwide, though a majority are located in Yvoir and Gyeonggi-do."

Answered by AI

Could you provide an estimation of the total number of participants enrolled in this trial?

"Alas, this clinical trial is no longer seeking new candidates. Initially posted 2/23/2021 and last edited on 7/4/2022, it has now ended its recruitment period. Nevertheless, there are currently 52 trials for eosinophilic esophagitis with open enrolment slots as well as seven research studies involving etrasimod that are still recruiting volunteers."

Answered by AI

Have there been any comparable studies conducted previously?

"Presently, 7 clinical trials involving Etrasimod are operating in 50 countries and 369 cities. Arena Pharmaceuticals initiated the first of these studies back in 2019; it entailed 912 participants, culminating with Phase 3 drug approval. Since then, 18332 experiments have been concluded."

Answered by AI

Is eligibility for this experiment restricted to individuals who are over sixty years of age?

"Patients that meet the criteria for this trial must be between 18 and 65 years old. Separately, 27 clinical trials welcome participants under 18 while 43 accommodate those over 65."

Answered by AI

Is there still an opportunity to take part in this trial?

"This clinical trial has since closed recruitment, with its first posting occurring on February 23rd 2021 and the last update being made July 4th 2022. For those seeking other medical trials, there are currently 52 that accept Eosinophilic Esophagitis patients and 7 for Etrasimod enrolment."

Answered by AI

In which geographical areas is this experiment currently taking place?

"At present, 54 distinct medical centres are running this trial. Locations include Cincinnati, Oklahoma City and Clearwater alongside other sites throughout the country; opting for a site located nearby can reduce travelling requirements for patients that choose to participate."

Answered by AI

Has the US Food and Drug Administration given its stamp of approval to Etrasimod?

"There is early clinical evidence that supports etrasimod's safety, so it was assigned a rating of 2."

Answered by AI

Might I be a viable candidate for this scientific experiment?

"This clinical trial is recruiting 108 patients suffering from eosinophilic esophagitis aged between 18 and 65. It's paramount that they meet the following conditions: having completed Week 24 study visit, with an EoE diagnosis earlier than screening, dysphagia episodes of more than two per week on a fortnightly basis during Screening period, no safety issues identified by Investigator in Double-Blind Treatment Period and agreement to comply with Extension Treatment Period’s visits and procedures."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
How old are they?
18 - 65
What site did they apply to?
Cotton-O'Neil Clinical Research Center, Digestive Health
Central Sooner Research
What portion of applicants met pre-screening criteria?
Met criteria
~25 spots leftby Apr 2025