Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
- Registration Number
- NCT05061446
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Japanese ancestry
- Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
- Having active UC confirmed by endoscopy
- Moderately to severely active UC
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Etrasimod Dose 1 Etrasimod - Placebo Placebo - Etrasimod Dose 2 Etrasimod -
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Clinical Remission at Week 12 Week 12 Clinical remission:Participants with stool frequency (SF)subscore=0(or of 1 with greater than or equal to(\>=)1 point decrease from baseline,rectal bleeding(RB)subscore=0 and endoscopic score(ES)less than or equal to(\<)=1(excluding friability).SF subscore:number of stools in 24-hours relative to normal number of stools for that participant in same period,score ranged from 0(normal number of stools) to 3(5 or more stools than normal),higher scores=more severity.RB subscore:most severe amount of blood passed per rectum in 24-hours,score ranged from 0(no blood seen)to 3(blood alone passes),higher scores=more severity.ES:reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,score ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding,ulceration\]),higher scores=more severity.Modified Mayo score:measure disease activity for UC,score:0(normal) to 9(maximum severity),comprised subscores for SF,RB,ES.higher score=more severe disease activity.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 Week 12 Endoscopic improvement was defined as ES \<= 1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity),and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.
Percentage of Participants Who Achieved Symptomatic Remission at Week 12 Week 12 Symptomatic remission was defined as SF sub score = 0 (or = 1 with a \>= 1 point decrease from baseline) and RB sub score = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.
Percentage of Participants Who Achieved Mucosal Healing at Week 12 Week 12 Mucosal healing was defined as ES \<= 1 (excluding friability) with histologic remission defined as a Geboes index score \< 2.0). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), comprised subscores for SF, RB, ES. Higher score = more severe disease activity.
Percentage of Participants Who Achieved Clinical Response at Week 12 Week 12 Clinical response was defined as a \>= 2-point and \>= 30 percentage (%) decrease from baseline in MMS, and a \>= 1-point decrease from baseline in RB subscore or an absolute RB subscore \<= 1. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity.
Percentage of Participants Who Achieved Endoscopic Normalization at Week 12 Week 12 Endoscopic normalization was defined as ES= 0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.
Trial Locations
- Locations (79)
NHO Hirosaki General Medical Center
🇯🇵Hirosaki-shi, Aomori-ken, Japan
Our Lady of the Snow St. Mary's Hospital
🇯🇵Kurume, Fukuoka, Japan
Kudo Internist Heart Clinic
🇯🇵Morioka-shi, Iwate-ken, Japan
Hamamatsu Medical Centre
🇯🇵Hamamatsu-shi, Shizuoka-ken, Japan
Toyohashi Municipal Hospital
🇯🇵Toyohashi-shi, Aichi- KEN, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Aichi, Japan
Kojunkai Daido Clinic
🇯🇵Nagoya-shi, Aichi, Japan
Nagoya City University Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Fujita Health University Hospital
🇯🇵Toyoake-City, Aichi, Japan
Kojunkai Daido Hospital
🇯🇵Nagoya-shi, Aixhi-ken, Japan
Hirosaki University Hospital(OCT/PFT/DLCO)
🇯🇵Hirosaki-shi, Aomori KEN, Japan
Hirosaki University Hospital
🇯🇵Hirosaki-shi, Aomori KEN, 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-shi, Ehime, Japan
Ehime University Hospital
🇯🇵Toon-shi, Ehime, Japan
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kokura Memorial Hospital
🇯🇵Kutakyushu-shi, Fukuoka, Japan
Kitakyushu Municipal Medical Center
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Koyanose Eye Clinic
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Japan Community Health Care Organization Kyushu Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
Fukuoka Shinmizumaki Hospital
🇯🇵Onga-gun, Fukuoka, Japan
Gifu University Hospital
🇯🇵Gifu-shi, Gifu-ken, 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-shi, Hiroshima, Japan
Asahikawa City Hospital
🇯🇵Asahikawa-shi, Hokkaido, Japan
Tokushukai Sapporo Tokushukai Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Sapporo-Kosei General Hospital
🇯🇵Sapporo-shi, 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-shi, Ishikawa, Japan
Iwate Medical University Uchimaru Medical Center
🇯🇵Morioka-shi, Iwate, Japan
Takamatsu Red Cross Hospital
🇯🇵Takamatsu-shi, Kagawa, Japan
JA- Kagoshima Koseiren Hospital (PET/DLCO)
🇯🇵Kagoshima-shi, Kagoshima, Japan
Clinical Pathology Laboratory (Diagnostick center)
🇯🇵Kagoshima-shi, Kagoshima, Japan
Sameshima Eye Clinic (OCT)
🇯🇵Kagoshima-shi, Kagoshima, Japan
Sameshima Hospital
🇯🇵Kagoshima-shi, Kagoshima, Japan
Sagamihara Kyodo Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
NHO Yokohama Medical Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Japanese Red Cross Kumamoto Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto-shi, Kyoto, Japan
National Hospital Organization Kyoto Medical Center
🇯🇵Kyoto-shi, Kyoto, Japan
Hinaga Nishi Ophthalmology Clinic
🇯🇵Yokkaichi- Shi, Mie-ken, Japan
Mie Prefectural General Medical Center
🇯🇵Yokkaichi-shi, Mie-ken, Japan
Mie University Hospital
🇯🇵Tsu-shi, MIE, Japan
JOHAS Tohoku Rosai Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Tohoku University 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-shi, Osaka, Japan
Japan Community Health care Organization Osaka Hospital
🇯🇵Osaka-shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki-City, Osaka, Japan
Saga University Hospital
🇯🇵Saga-shi, Saga, Japan
Japan Community Health care Organization Saitama Medical Center
🇯🇵Saitama-shi, Saitama-ken, Japan
Saitama Medical University Hospital
🇯🇵Iruma-gun, Saitama, Japan
Shiga University of Medical Science Hospital
🇯🇵Otsu, Shiga, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Matsuda Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Tokai University Hachioji Hospital
🇯🇵Hachioji, 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-shi, Wakayama, Japan
Yamanashi Prefectural Central Hospital
🇯🇵Kofu-shi, 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