Clinical trial NCT05061446: Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
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 Participants With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
APD334
Etrasimod
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Arena is a wholly owned subsidiary of Pfizer
First posted: 2021-09-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved Symptomatic Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved Mucosal Healing at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved Clinical Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved Endoscopic Normalization at Week 12
timeFrame: Week 12
Other outcomes:
measure: Number of Participants With Adverse Events According to Severity
timeFrame: Day 1 of first dose of study treatment up to 4 weeks after administration of the final dose of study treatment (maximum up to 16 weeks)
Locations:
city: Toyohashi-shi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi- KEN
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Kojunkai Daido Clinic
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Toyoake-City
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Kojunkai Daido Hospital
state: Aixhi-ken
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital(OCT/PFT/DLCO)
state: Aomori KEN
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital
state: Aomori KEN
city: Hirosaki-shi
country: Japan
facility: NHO Hirosaki General Medical Center
state: Aomori-ken
city: Kashiwa-shi
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
state: Chiba
city: Nagareyama-shi
country: Japan
facility: Ishii Eye Clinic
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Saiseikai Matsuyama Hospital
state: Ehime
city: Toon-shi
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Kitakyushu Municipal Medical Center
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Koyanose Eye Clinic
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Japan Community Health Care Organization Kyushu Hospital
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Our Lady of the Snow St. Mary's Hospital
state: Fukuoka
city: Kutakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Onga-gun
country: Japan
facility: Fukuoka Shinmizumaki Hospital
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu-ken
city: Ota-shi
country: Japan
facility: SUBARU Health Insurance Society Ota Memorial Hospital
state: Gunma
city: Fukuyama-shi
country: Japan
facility: Nakayama EYE Clinic
state: Hiroshima
city: Fukuyama-shi
country: Japan
facility: NHO Fukuyama Medical Center
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Asahikawa City Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Tokushukai Sapporo Tokushukai Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo-Kosei General Hospital
state: Hokkaido
city: Higashiibaraki-gun
country: Japan
facility: NHO Mito Medical Center
state: Ibaraki
city: Koga-shi
country: Japan
facility: Yuai Memorial Hospital
state: Ibaraki
city: Sashima-gun
country: Japan
facility: Ibaraki Seinan Medical Center Hospital
state: Ibaraki
city: Toride-shi
country: Japan
facility: Matsumoto Eye Clinic
state: Ibaraki
city: Tsuchiura-shi
country: Japan
facility: Tsuchiura Kyodo General Hospital
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: NHO Kanazawa Medical Center
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Kudo Internist Heart Clinic
state: Iwate-ken
city: Morioka-shi
country: Japan
facility: Iwate Medical University Uchimaru Medical Center
state: Iwate
city: Takamatsu-shi
country: Japan
facility: Takamatsu Red Cross Hospital
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: JA- Kagoshima Koseiren Hospital (PET/DLCO)
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Clinical Pathology Laboratory (Diagnostick center)
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Sameshima Eye Clinic (OCT)
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Sameshima Hospital
state: Kagoshima
city: Sagamihara
country: Japan
facility: Sagamihara Kyodo Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: NHO Yokohama Medical Center
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Kyoto-shi
country: Japan
facility: National Hospital Organization Kyoto Medical Center
state: Kyoto
city: Yokkaichi- Shi
country: Japan
facility: Hinaga Nishi Ophthalmology Clinic
state: Mie-ken
city: Yokkaichi-shi
country: Japan
facility: Mie Prefectural General Medical Center
state: Mie-ken
city: Tsu-shi
country: Japan
facility: Mie University Hospital
state: MIE
city: Sendai-shi
country: Japan
facility: JOHAS Tohoku Rosai Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Nagaoka-shi
country: Japan
facility: Nagaoka Red Cross Hospital
state: Niigata
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Kishiwada-shi
country: Japan
facility: Medical Corporation Tokushukai Kishiwada Tokushukai Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Japan Community Health care Organization Osaka Hospital
state: Osaka
city: Takatsuki-City
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Saga-shi
country: Japan
facility: Saga University Hospital
state: Saga
city: Saitama-shi
country: Japan
facility: Japan Community Health care Organization Saitama Medical Center
state: Saitama-ken
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu Medical Centre
state: Shizuoka-ken
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Matsuda Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hospital
state: Tokyo
city: Kodaira-shi
country: Japan
facility: Showa General Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: JCHO Tokyo Yamate Medical Center
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
city: Kofu-shi
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Osaka
country: Japan
facility: NHO Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka National Hospital Institutional Review Board
city: Tokyo
country: Japan
facility: Teikyo University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: