A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in Japanese Participants With Moderately to Severely Active Ulcerative Colitis
Who is this study for? Patients with Ulcerative Colitis
What treatments are being studied? Etrasimod
Status: Completed
Location: See all (80) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Japanese ancestry
• Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
• Having active UC confirmed by endoscopy
• Moderately to severely active UC
Locations
Other Locations
Japan
Asahikawa City Hospital
Asahikawa-shi
Tokyo Medical and Dental University Hospital
Bunkyo-ku
Fukuoka University Hospital
Fukuoka
Fukushima Medical University Hospital
Fukushima
Nakayama EYE Clinic
Fukuyama-shi
NHO Fukuyama Medical Center
Fukuyama-shi
Gifu University Hospital
Gifu
Tokai University Hachioji Hospital
Hachiōji
Hamamatsu Medical Centre
Hamamatsu
Hamamatsu University Hospital
Hamamatsu
Matsuda Hospital
Hamamatsu
NHO Mito Medical Center
Higashiibaraki-gun
Kansai Medical University Hospital
Hirakata-shi
Hirosaki University Hospital
Hirosaki-shi
Hirosaki University Hospital(OCT/PFT/DLCO)
Hirosaki-shi
NHO Hirosaki General Medical Center
Hirosaki-shi
Hiroshima University Hospital
Hiroshima
Saitama Medical University Hospital
Iruma-gun
Clinical Pathology Laboratory (Diagnostick center)
Kagoshima
JA- Kagoshima Koseiren Hospital (PET/DLCO)
Kagoshima
Kagoshima University Hospital
Kagoshima
Sameshima Eye Clinic (OCT)
Kagoshima
Sameshima Hospital
Kagoshima
NHO Kanazawa Medical Center
Kanazawa
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi
Medical Corporation Tokushukai Kishiwada Tokushukai Hospital
Kishiwada-shi
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu
Kitakyushu Municipal Medical Center
Kitakyushu-shi
Kokura Memorial Hospital
Kitakyushu-shi
Koyanose Eye Clinic
Kitakyushu-shi
Showa General Hospital
Kodaira-shi
Yamanashi Prefectural Central Hospital
Kofu
Yuai Memorial Hospital
Koga-shi
Japanese Red Cross Kumamoto Hospital
Kumamoto
Our Lady of the Snow St. Mary's Hospital
Kurume
Kurume University Hospital
Kurume-shi
Kokura Memorial Hospital
Kutakyushu-shi
National Hospital Organization Kyoto Medical Center
Kyoto
University Hospital Kyoto Prefectural University of Medicine
Kyoto
Saiseikai Matsuyama Hospital
Matsuyama
Kitasato University Kitasato Institute Hospital
Minato-ku
Iwate Medical University Uchimaru Medical Center
Morioka
Kudo Internist Heart Clinic
Morioka
Aichi Medical University Hospital
Nagakute
Nagaoka Red Cross Hospital
Nagaoka-shi
Ishii Eye Clinic
Nagareyama-shi
Kojunkai Daido Clinic
Nagoya
Kojunkai Daido Hospital
Nagoya
Nagoya City University Hospital
Nagoya
Fukuoka Shinmizumaki Hospital
Onga-gun
Japan Community Health care Organization Osaka Hospital
Osaka
NHO Osaka National Hospital
Osaka
Osaka City University Hospital
Osaka
Osaka National Hospital Institutional Review Board
Osaka
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi
Shiga University of Medical Science Hospital
Ōtsu
Saga University Hospital
Saga
Sagamihara Kyodo Hospital
Sagamihara
Japan Community Health care Organization Saitama Medical Center
Saitama-shi
Toho University Sakura Medical Center
Sakura
Sapporo-Kosei General Hospital
Sapporo
Tokushukai Sapporo Tokushukai Hospital
Sapporo
Ibaraki Seinan Medical Center Hospital
Sashima-gun
JOHAS Tohoku Rosai Hospital
Sendai
Tohoku University Hospital
Sendai
JCHO Tokyo Yamate Medical Center
Shinjuku-ku
Takamatsu Red Cross Hospital
Takamatsu
Osaka Medical and Pharmaceutical University Hospital
Takatsuki
Teikyo University Hospital
Tokyo
Ehime University Hospital
Toon-shi
Matsumoto Eye Clinic
Toride-shi
Fujita Health University Hospital
Toyoake
Toyohashi Municipal Hospital
Toyohashi
Mie University Hospital
Tsu
Tsuchiura Kyodo General Hospital
Tsuchiura-shi
Wakayama Medical University Hospital
Wakayama
Hinaga Nishi Ophthalmology Clinic
Yokkaichi- Shi
Mie Prefectural General Medical Center
Yokkaichi-shi
NHO Yokohama Medical Center
Yokohama
Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
Yokohama
Time Frame
Start Date: 2021-09-10
Completion Date: 2023-10-06
Participants
Target number of participants: 54
Treatments
Experimental: Etrasimod Dose 1
Experimental: Etrasimod Dose 2
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: Arena is a wholly owned subsidiary of Pfizer
Leads: Pfizer