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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 : December 12, 2022
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Arena Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE December 19, 2020
First Posted Date  ICMJE December 24, 2020
Last Update Posted Date December 12, 2022
Actual Study Start Date  ICMJE December 15, 2020
Actual Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2020)
Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) [ Time Frame: Baseline to Week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 4, 2022)
108
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2020)
96
Estimated Study Completion Date  ICMJE July 4, 2023
Actual Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Netherlands,   Spain,   Switzerland,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT04682639
Other Study ID Numbers  ICMJE 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  ICMJE
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 Arena Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arena Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Arena Pharmaceuticals
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP