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

Sponsor
Arena Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04682639
Collaborator
(none)
108
Enrollment
78
Locations
3
Arms
27.2
Anticipated Duration (Months)
1.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel 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 :
Feb 23, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • APD334

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) [Baseline to Week 16]

    2. Number of participants with treatment emergent adverse events (AEs) [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)]

    Secondary Outcome Measures

    1. Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score [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 [Baseline to Week 16]

    3. Proportion of Participants With Esophageal PEC <15 Eosinophils per High Powered Field (eos/hpf) [Baseline to Week 16]

    4. Proportion of Participants With Esophageal PEC ≤ 6 eos/hpf [Baseline to Week 16]

    5. Number and Severity of Adverse Events (Double-Blind Treatment Period and Extension Treatment Period) [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

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Clinical Research Center of Alabama Birmingham Alabama United States 35209
    2 Digestive Health Specialists of the Southeast Dothan Alabama United States 36305
    3 Avant Research Associates, LLC Huntsville Alabama United States 35802
    4 Arizona Digestive Health Sun City Arizona United States 85351
    5 Premier Gastroenterology Little Rock Arkansas United States 72212
    6 University of California at Irvine Medical Center Irvine California United States 92697-7600
    7 Gastro Care Institute Lancaster California United States 93534
    8 Om Research LLC Lancaster California United States 93534
    9 Keck Hospital of USC Los Angeles California United States 90033
    10 United Medical Doctors Murrieta California United States 92563
    11 Jupiter Outpatient Surgery Center Boynton Beach Florida United States 33472
    12 Gastro Florida Clearwater Florida United States 33756
    13 Gastro Florida Clearwater Florida United States 33761
    14 Nature Coast Clinical Research Inverness Florida United States 34452
    15 University of Florida Health Gastroenterology Jacksonville Florida United States 32209
    16 Auzmer Research Lakeland Florida United States 33813
    17 Research Associates of South Florida, LLC Miami Florida United States 33156
    18 Digestive Healthcare of Georgia Atlanta Georgia United States 30309
    19 Atlanta Center for Gastroenterology, P.C. Decatur Georgia United States 30033
    20 Grand Teton Research Group, PLLC Idaho Falls Idaho United States 83404
    21 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    22 University of Chicago Medical Center Chicago Illinois United States 60637
    23 Glenbrook Hospital - Cardiology Glenview Illinois United States 60026
    24 Illinois Gastroenterology Group Gurnee Illinois United States 60031
    25 GHP Research New Albany Indiana United States 47150
    26 Cotton-O'Neil Clinical Research Center, Digestive Health Topeka Kansas United States 66606
    27 Gastroenterology Clinic of Acadiana, Ltd. Lafayette Louisiana United States 70503
    28 Tufts Medical Center Boston Massachusetts United States 02111
    29 Gastroenterology Associates of Western Michigan, P.L.C. Wyoming Michigan United States 49519
    30 University of Minnesota Minneapolis Minnesota United States 55455
    31 Mayo Clinic - Rochester Rochester Minnesota United States 55905
    32 Allied Digestive Health Brick New Jersey United States 08724
    33 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
    34 Duke University Medical Center Durham North Carolina United States 27710
    35 Fayetteville Gastroenterology Associates Fayetteville North Carolina United States 28304
    36 Consultants for Clinical Research Inc. Cincinnati Ohio United States 45219
    37 UC Health, LLC. Cincinnati Ohio United States 45267
    38 Aventiv Research, Inc. Dublin Ohio United States 43016
    39 Great Lakes Gastroenterology Research, LLC Mentor Ohio United States 44060
    40 Integris Baptist Medical Center Oklahoma City Oklahoma United States 73112
    41 Central Sooner Research Oklahoma City Oklahoma United States 73118
    42 Susquehanna Research Group, LLC Harrisburg Pennsylvania United States 17110
    43 University of Pennsylvania Philadelphia Pennsylvania United States 19104-6061
    44 Regional Gastroenterology Associates of Lancaster, Ltd Wyomissing Pennsylvania United States 19610
    45 Innovative Clinical Research Rapid City South Dakota United States 57701
    46 Tri-Cities Gastroenterology Kingsport Tennessee United States 37663
    47 GI for Kids Knoxville Tennessee United States 37922
    48 Vanderbilt University Medical Center - Digestive Disease Center Nashville Tennessee United States 37232
    49 The University of Texas at Austin Austin Texas United States 78712
    50 Digestive Health Associates of Texas Garland Texas United States 75044
    51 Texas Digestive Disease Consultants - San Marcos San Marcos Texas United States 78666
    52 GI Alliance Webster Texas United States 77598
    53 University of Utah Hospital Salt Lake City Utah United States 84132
    54 Gastroenterology Associates of Tidewater Chesapeake Virginia United States 23320
    55 Blue Ridge Medical Research Lynchburg Virginia United States 24502
    56 Coastal Digestive Health Maroochydore Queensland Australia 4558
    57 Coral Sea Clinical Research Institute North Mackay Queensland Australia
    58 Mater Hospital Brisbane South Brisbane Queensland Australia 4101
    59 Lyell McEwin Hospital Elizabeth Vale South Australia Australia 5112
    60 Ballarat Base Hospital Ballarat Victoria Australia 3350
    61 Box Hill Hospital Box Hill Victoria Australia 3128
    62 The Northern Hospital Epping Victoria Australia 3076
    63 Footscray Hospital Footscray Victoria Australia 3011
    64 Princess Alexandra Hospital Woolloongabba Australia 4102
    65 AZ Sint-Lucas Brugge Belgium 8310
    66 Universitair Ziekenhuis Gent Gent Belgium 9000
    67 UZ Leuven Leuven Belgium 3000
    68 AZ Delta Roeselare Belgium 8800
    69 Centre Wallonie Picarde Tournai Belgium 7500
    70 KRH Klinikum Siloah Stadionbrücke 4 Hannover Germany 30459
    71 Amsterdam UMC, Locatie AMC Amsterdam Netherlands 1105 AZ
    72 Hospital Costa del Sol Marbella Malaga Spain 29603
    73 Hospital General Universitario de Alicante Alicante Spain 03010
    74 Hospital Universitario de La Princesa Madrid Spain 28006
    75 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    76 Hospital Universitario Miguel Servet Zaragoza Spain 50009
    77 Kantonsspital St. Gallen Saint Gallen Switzerland 9007
    78 Universitatsspital Zuerich Zurich Switzerland

    Sponsors and Collaborators

    • Arena Pharmaceuticals

    Investigators

    • Study Director: Arena CT.gov Administrator, Arena Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arena Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04682639
    Other Study ID Numbers:
    • APD334-206
    • 2020-003226-23
    First Posted:
    Dec 24, 2020
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arena Pharmaceuticals
    Eosinophilic esophagitis
    Esophageal eosinophilia
    Etrasimod
    APD334
    EoE
    Eosinophilic oesophagitis
    Additional relevant MeSH terms:
    Esophagitis
    Eosinophilic Esophagitis

    Study Results

    No Results Posted as of Jul 7, 2022