Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT05061446
Last Updated: 2024-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2021-09-10
2023-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Etrasimod Dose 1
Etrasimod
Etrasimod tablet by mouth, once daily for 12 weeks
Etrasimod Dose 2
Etrasimod
Etrasimod tablet by mouth, once daily for 12 weeks
Placebo
Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks
Interventions
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Etrasimod
Etrasimod tablet by mouth, once daily for 12 weeks
Etrasimod
Etrasimod tablet by mouth, once daily for 12 weeks
Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
* Having active UC confirmed by endoscopy
* Moderately to severely active UC
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Arena is a wholly owned subsidiary of Pfizer
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Kojunkai Daido Clinic
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan
Kojunkai Daido Hospital
Nagoya, Aixhi-ken, Japan
NHO Hirosaki General Medical Center
Hirosaki-shi, Aomori, Japan
Hirosaki University Hospital(OCT/PFT/DLCO)
Hirosaki-shi, Aomori, Japan
Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, Japan
Ishii Eye Clinic
Nagareyama-shi, Chiba, Japan
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, Japan
Ehime University Hospital
Toon-shi, Ehime, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu, Fukuoka, Japan
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan
Kitakyushu Municipal Medical Center
Kitakyushu-shi, Fukuoka, Japan
Koyanose Eye Clinic
Kitakyushu-shi, Fukuoka, Japan
Our Lady of the Snow St. Mary's Hospital
Kurume, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Kokura Memorial Hospital
Kutakyushu-shi, Fukuoka, Japan
Fukuoka Shinmizumaki Hospital
Onga-gun, Fukuoka, Japan
Gifu University Hospital
Gifu, Gifu, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, Japan
Nakayama EYE Clinic
Fukuyama-shi, Hiroshima, Japan
NHO Fukuyama Medical Center
Fukuyama-shi, Hiroshima, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, Japan
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, Japan
NHO Mito Medical Center
Higashiibaraki-gun, Ibaraki, Japan
Yuai Memorial Hospital
Koga-shi, Ibaraki, Japan
Ibaraki Seinan Medical Center Hospital
Sashima-gun, Ibaraki, Japan
Matsumoto Eye Clinic
Toride-shi, Ibaraki, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura-shi, Ibaraki, Japan
NHO Kanazawa Medical Center
Kanazawa, Ishikawa-ken, Japan
Kudo Internist Heart Clinic
Morioka, Iwate, Japan
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, Japan
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, Japan
JA- Kagoshima Koseiren Hospital (PET/DLCO)
Kagoshima, Kagoshima-ken, Japan
Clinical Pathology Laboratory (Diagnostick center)
Kagoshima, Kagoshima-ken, Japan
Sameshima Eye Clinic (OCT)
Kagoshima, Kagoshima-ken, Japan
Sameshima Hospital
Kagoshima, Kagoshima-ken, Japan
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, Japan
Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa, Japan
NHO Yokohama Medical Center
Yokohama, Kanagawa, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Kyoto, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Hinaga Nishi Ophthalmology Clinic
Yokkaichi- Shi, Mie-ken, Japan
Mie Prefectural General Medical Center
Yokkaichi-shi, Mie-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
JOHAS Tohoku Rosai Hospital
Sendai, Miyagi, Japan
Nagaoka Red Cross Hospital
Nagaoka-shi, Niigata, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Medical Corporation Tokushukai Kishiwada Tokushukai Hospital
Kishiwada-shi, Osaka, Japan
Osaka City University Hospital
Osaka, Osaka, Japan
Japan Community Health care Organization Osaka Hospital
Osaka, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Saga University Hospital
Saga, Saga-ken, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan
Japan Community Health care Organization Saitama Medical Center
Saitama-shi, Saitama, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Matsuda Hospital
Hamamatsu, Shizuoka, Japan
Hamamatsu Medical Centre
Hamamatsu, Shizuoka, Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku, Tokyo, Japan
Tokai University Hachioji Hospital
Hachiōji, Tokyo, Japan
Showa General Hospital
Kodaira-shi, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan
JCHO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
NHO Osaka National Hospital
Osaka, , Japan
Osaka National Hospital Institutional Review Board
Osaka, , Japan
Teikyo University Hospital
Tokyo, , Japan
Countries
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References
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Takeuchi K, Nakase H, Hisamatsu T, Matsuoka K, Arai S, Yuasa H, Oe M, Ono R, Keating M, Gu G, Lazin K, McDonnell A, Fukuta K, Hibi T. Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study. Intest Res. 2025 Apr 25. doi: 10.5217/ir.2024.00213. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5041007
Identifier Type: OTHER
Identifier Source: secondary_id
APD334-203
Identifier Type: -
Identifier Source: org_study_id
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