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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Eosinophilic Esophagitis

Treatments: Drug: Etrasimod; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04682639

2020-003226-23 (EudraCT Number)

C5041009 (Other Identifier)

APD334-206

Details and patient eligibility

About

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.

Enrollment: 108 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)
• Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of ≥ 2 episodes per week over 2 weeks during the Screening period

Inclusion Criteria for the Extension Treatment Period

• Completion of the Week 24 study visit [including esophagogastroduodenoscopy (EGD)]
• 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
• Willing to comply with all study visits and procedures for the Extension Treatment Period

Exclusion criteria

• History of any of the non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic (eg eosinophilic gastritis), endoscopic (eg, high-grade esophageal stenosis), or symptom endpoints (eg, esophageal resection) of the study

• 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:

  1. Elemental diet
  2. EoE food trigger elimination diet
  3. Proton pump inhibitor (PPI) therapy

• Used any immunotherapy/desensitization including oral immunotherapy (OIT) or sublingual immunotherapy (SLIT) within 12 months prior to the Screening EGD. Note: Stable (ie, ≥ 6 months prior to the Screening EGD) subcutaneous immunotherapy (SCIT) is permitted. Participants on SCIT need to stay on a stable treatment during study participation

• Used any protocol-specified immunomodulatory therapies within the protocol-specified timeframe prior to Baseline (eg, dupilumab, benralizumab, omalizumab, or infliximab within 12 weeks; a sphingosine-1-phosphate receptor modulator at any time)

• Use of any investigational agent or device within 12 weeks prior to Baseline

• Females who are pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

108 participants in 3 patient groups, including a placebo group

Etrasimod Dose 1

Experimental group

Treatment:

Drug: Etrasimod

Drug: Etrasimod

Etrasimod Dose 2

Experimental group

Treatment:

Drug: Etrasimod

Drug: Etrasimod

Placebo and Etrasimod

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Etrasimod

Drug: Etrasimod