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

• ClinicalTrials.gov Identifier: NCT04682639
• Recruitment Status: Active, not recruiting
• First Posted: December 24, 2020
• Last Update Posted: March 13, 2023
• Sponsor: Pfizer
• Collaborator: Arena is a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: December 19, 2020
• First Posted Date: December 24, 2020
• Last Update Posted Date: March 13, 2023
• Actual Study Start Date: December 15, 2020
• Actual Primary Completion Date: September 30, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 19, 2020): Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) [ Time Frame: Baseline to Week 16 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 14, 2022)

• Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score [ Time Frame: Baseline to Week 16 ]
  The DSQ is used to measure the intensity of dysphagia. DSQ scores can range from 0 to 84, with a higher score indicating more-frequent or more-severe dysphagia.
• Absolute Change From Baseline in Esophageal PEC [ Time Frame: Baseline to Week 16 ]
• Proportion of Participants With Esophageal PEC <15 Eosinophils per High Powered Field (eos/hpf) [ Time Frame: Baseline to Week 16 ]
• Proportion of Participants With Esophageal PEC ≤ 6 eos/hpf [ Time Frame: Baseline to Week 16 ]
• Number and Severity of Adverse Events (Double-Blind Treatment Period and Extension Treatment Period) [ Time Frame: Up to approximately 56 weeks (24 weeks of Double-Blind Treatment Period, 28 weeks of Extension Treatment Period, and 4 weeks of Safety Follow-Up Period) ]
  Safety outcomes will be based on adverse events, clinical laboratory, and other safety assessments

Original Secondary Outcome Measures (submitted: December 19, 2020)

• Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score [ Time Frame: Baseline to Week 16 ]
• Absolute Change From Baseline in Esophageal PEC [ Time Frame: Baseline to Week 16 ]
• Proportion of Participants With Esophageal PEC <15 Eosinophils per High Powered Field (eos/hpf) [ Time Frame: Baseline to Week 16 ]
• Proportion of Participants With Esophageal PEC ≤ 6 eos/hpf [ Time Frame: Baseline to Week 16 ]
• Number and Severity of Adverse Events (Double-Blind Treatment Period and Extension Treatment Period) [ Time Frame: Up to approximately 56 weeks (24 weeks of Double-Blind Treatment Period, 28 weeks of Extension Treatment Period, and 4 weeks of Safety Follow-Up Period) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
• Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic Esophagitis
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Eosinophilic Esophagitis

Intervention

• Drug: Etrasimod
  Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.
  Other Name: APD334
• Drug: Placebo
  Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.
• Drug: Etrasimod
  Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period.
  Other Name: APD334

Study Arms

• Experimental: Etrasimod Dose 1
  Intervention: Drug: Etrasimod
• Experimental: Etrasimod Dose 2
  Intervention: Drug: Etrasimod
• Placebo Comparator: Placebo and Etrasimod
  Participants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.
  Interventions:

  • Drug: Placebo
  • Drug: Etrasimod

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 4, 2022): 108
• Original Estimated Enrollment (submitted: December 19, 2020): 96
• Estimated Study Completion Date: July 4, 2023
• Actual Primary Completion Date: September 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Netherlands, Spain, Switzerland, United States
• Removed Location Countries: Germany

Administrative Information

• NCT Number: NCT04682639
• Other Study ID Numbers: APD334-206; C5041009 ( Other Identifier: Alias Study Number ); 2020-003226-23 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Current Responsible Party: Pfizer
• Original Responsible Party: Arena Pharmaceuticals
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Arena Pharmaceuticals
• Collaborators: Arena is a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2023