A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis

(VOYAGE Trial)

Recruiting at299 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Arena Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Inclusion Criteria

Compliance with study procedures during the Double-Blind Treatment Period as assessed by the Investigator

No notable safety concerns during the Double-Blind Treatment Period, as determined by the Investigator

Have an eosinophilic esophagitis (EoE) diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of ≥ 15 eosinophils per high powered field (eos/hpf)

Exclusion Criteria

Undergone dilation of an esophageal stricture within 12 weeks prior to Screening EGD

Use of corticosteroids for the treatment of EoE within 8 weeks prior to Screening EGD

Discontinue, initiate, or change dosing (dosage/frequency) of the following therapies for EoE within 8 weeks prior to Screening EGD. Participants on any of the following therapy need to stay on a stable regimen during study participation: Elemental diet, EoE food trigger elimination diet, Proton pump inhibitor (PPI) therapy

Treatment Details

Interventions

• Etrasimod (Sphingosine 1-phosphate receptor modulator)
• Placebo (Drug)

Participant Groups

Group I: Etrasimod Dose 2 Experimental Treatment 1 Intervention

Group II: Etrasimod Dose 1 Experimental Treatment 1 Intervention

Group III: Placebo and Etrasimod Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Arena Pharmaceuticals

Lead Sponsor

Trials

29

Recruited

5,800+

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Arena is a wholly owned subsidiary of Pfizer

Collaborator

Trials

7

Recruited

2,500+

Arena is a wholly owned subsidiary of Pfizer

Industry Sponsor

Trials

11

Recruited

2,600+