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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04682639
Recruitment Status : Active, not recruiting
First Posted : December 24, 2020
Last Update Posted : March 13, 2023
Sponsor:
Collaborator:
Arena is a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Etrasimod Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2020
Actual Primary Completion Date : September 30, 2022
Estimated Study Completion Date : July 4, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Etrasimod Dose 1 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
Experimental: Etrasimod Dose 2 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. 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.

  2. Absolute Change From Baseline in Esophageal PEC [ Time Frame: Baseline to Week 16 ]
  3. Proportion of Participants With Esophageal PEC <15 Eosinophils per High Powered Field (eos/hpf) [ Time Frame: Baseline to Week 16 ]
  4. Proportion of Participants With Esophageal PEC ≤ 6 eos/hpf [ Time Frame: Baseline to Week 16 ]
  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682639


Locations
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Sponsors and Collaborators
Pfizer
Arena is a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04682639    
Other Study ID Numbers: APD334-206
C5041009 ( Other Identifier: Alias Study Number )
2020-003226-23 ( EudraCT Number )
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Eosinophilic esophagitis
Esophageal eosinophilia
Etrasimod
 APD334
EoE
Eosinophilic oesophagitis
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases