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Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Sponsor
Arena Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05061446
Collaborator
(none)
96
Enrollment
60
Locations
3
Arms
25.5
Anticipated Duration (Months)
1.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date :
Oct 16, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Etrasimod Dose 1

Drug: Etrasimod
Etrasimod tablet by mouth, once daily for 12 weeks
Other Names:
  • APD334

    		•
    Experimental: Etrasimod Dose 2

    Drug: Etrasimod
    Etrasimod tablet by mouth, once daily for 12 weeks
    Other Names:
  • APD334

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants Achieving Clinical Remission [Week 12]

    Secondary Outcome Measures

    1. Proportion of Participants Achieving Endoscopic Improvement [Week 12]

    2. Proportion of Participants Achieving Symptomatic Remission [Week 12]

    3. Proportion of Participants with Mucosal Healing [Week 12]

    4. Proportion of Participants Achieving Clinical Response [Week 12]

    5. Proportion of Participants Achieving Endoscopic Normalization [Week 12]

    6. Number and Severity of Adverse Events [up to approximately 16 weeks]

      Safety will be assessed by monitoring adverse events and clinically significant changes in vital signs and clinical laboratory results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Japanese ancestry

    • Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening

    • Having active UC confirmed by endoscopy

    • Moderately to severely active UC

    Exclusion Criteria:

    • Severe extensive colitis

    • Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD

    • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Koujunkai Daido Clinic Nagoya-shi Aichi-Ken Japan 457-8511
    2 Toyohashi Municipal Hospital Toyohashi-shi Aichi-Ken Japan 441-8570
    3 Nagoya City University Hospital Nagoya-shi Aichi Japan 467-8602
    4 Fujita Health University Hospital Toyoake Aichi Japan 470-1192
    5 NHO Hirosaki National Hospital Hirosaki-shi Aomori-Ken Japan 036-8545
    6 Hirosaki University Hospital Hirosaki-shi Aomori-Ken Japan 036-8563
    7 Tsujinaka Hospital Kashiwanoha Kashiwa-shi Chiba Japan 277-0871
    8 Saiseikai Matsuyama Hospital Matsuyama-shi Ehime Japan 791-8026
    9 Ehime University Hospital Toon-shi Ehime Japan 791-0295
    10 Fukuoka University Hospital Fukuoka-shi Fukuoka Japan 814-0180
    11 Kitakyushu Municipal Medical Center Kitakyushu-shi Fukuoka Japan 802-8561
    12 JCHO Kyushu Hospital Kitakyushu-shi Fukuoka Japan 806-8501
    13 Kokura Memorial Hospital Kitakyushu Fukuoka Japan 802-8555
    14 Kurume University Hospital Kurume-shi Fukuoka Japan 830-0011
    15 Fukuoka Shinmizumaki Hospital Tateyashiki Fukuoka Japan 807-0051
    16 Fukushima Medical University Hospital Fukushima-shi Fukushima Japan 960-1295
    17 Gifu University Hospital Gifu-shi Gifu-Ken Japan 501-1194
    18 SUBARU Health Insurance Society Ota Memorial Hospital Ota-shi Gunma Japan 373-8585
    19 NHO Fukuyama Medical Center Fukuyama-shi Hiroshima Japan 720-8520
    20 Hiroshima University Hospital Hiroshima-shi Hiroshima Japan 734-8551
    21 Asahikawa City Hospital Asahikawa-shi Hokkaido Japan 070-8610
    22 Tokushukai Sapporo Tokushukai Hospital Sapporo-shi Hokkaido Japan 004-0041
    23 Sapporo-Kosei General Hospital Sapporo-shi Hokkaido Japan 060-0033
    24 NHO Mito Medical Center Higashi Ibaraki Japan 311-3193
    25 Yuai Memorial Hospital Koga-shi Ibaraki Japan 306-0232
    26 Tsuchiura Kyodo General Hospital Tsuchiura-shi Ibaraki Japan 300-0028
    27 NHO Kanazawa Medical Center Kanazawa-shi Ishikawa Japan 920-8650
    28 Iwate Medical University Uchimaru Medical Center Morioka-shi Iwate Japan 020-8505
    29 Takamatsu Red Cross Hospital Takamatsu-shi Kagawa Japan 760-0017
    30 Kagoshima University Hospital Kagoshima-shi Kagoshima Japan 890-8520
    31 Sameshima Hospital Kagoshima-shi Kagoshima Japan 892-0846
    32 Sagamihara Kyodo Hospital Sagamihara-shi Kanagawa Japan 252-5188
    33 Social Welfare Organization Imperial Gift Foundation Inc. Saiseikai Yokohamashi Nanbu Hospital Yokohama-shi Kanagawa Japan 234-0054
    34 NHO Yokohama Medical Center Yokohama-shi Kanagawa Japan 245-8575
    35 Japanese Red Cross Kumamoto Hospital Kumamoto-shi Kumamoto Japan 861-8520
    36 University Hospital, Kyoto Prefectural University of Medicine Kyoto-shi Kyoto Japan 602-8566
    37 NHO Kyoto Medical Center Kyoto-shi Kyoto Japan 612-8555
    38 Mie Prefectural General Medical Center Yokkaichi-shi Mie-Ken Japan 510-8561
    39 Mie University Hospital Tsu-shi Mie Japan 514-8507
    40 Tohoku University Hospital Sendai-shi Miyagi Japan 980-8574
    41 JOHAS Tohoku Rosai Hospital Sendai-shi Miyagi Japan 981-8563
    42 Nagaoka Red Cross Hospital Nagaoka-shi Niigata-Ken Japan 940-2085
    43 Kansai Medical University Hospital Hirakata-shi Osaka Japan 573-1191
    44 Kishiwada Tokushukai Hospital, Medical Corporation Tokushukai Kishiwada-shi Osaka Japan 596-8522
    45 Osaka City University Hospital Osaka-shi Osaka Japan 545-8586
    46 Japan Community Health Care Organization Osaka Hospital Osaka-shi Osaka Japan 553-0003
    47 Osaka Medical and Pharmaceutical University Hospital Takatsuki-shi Osaka Japan 569-8686
    48 Saga University Hospital Saga-shi Saga Japan 849-8501
    49 JCHO Saitama Medical Center Saitama-shi Saitama-Ken Japan 330-0074
    50 Saitama Medical University Hospital Iruma-gun Saitama Japan 350-0495
    51 Shiga University of Medical Science Hospital Otsu-shi Shiga Japan 520-2192
    52 Hamamatsu University School of Medicine, University Hospital Hamamatsu-shi Shizuoka-Ken Japan 431-3192
    53 Matsuda Hospital Hamamatsu-shi Shizuoka Japan 432-8061
    54 Tokyo Medical And Dental University Hospital Bunkyo-ku Tokyo Japan 113-8519
    55 Teikyo University Hospital Itabashi-ku Tokyo Japan 173-8606
    56 Showa General Hospital Kodaira-shi Tokyo Japan 187-8510
    57 Kitasato University Kitasato Institute Hospital Minato-ku Tokyo Japan 108-8642
    58 JCHO Tokyo Yamate Medical Center Shinjuku-ku Tokyo Japan 169-0073
    59 Wakayama Medical University Hospital Wakayama-shi Wakayama Japan 641-8510
    60 Yamanashi Prefectural Central Hospital Kofu-shi Yamanashi Japan 400-8506

    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:
    NCT05061446
    Other Study ID Numbers:
    • APD334-203
    First Posted:
    Sep 29, 2021
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 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
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Arena Pharmaceuticals
    Ulcerative Colitis
    APD334
    Etrasimod
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer

    Study Results

    No Results Posted as of Jun 8, 2022