Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
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
2 other identifiers
interventional
54
1 country
80
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2021
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2021
CompletedFirst Submitted
Initial submission to the registry
September 20, 2021
CompletedFirst Posted
Study publicly available on registry
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2023
CompletedResults Posted
Study results publicly available
October 29, 2024
CompletedOctober 29, 2024
October 1, 2024
2.1 years
September 20, 2021
October 3, 2024
October 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved Clinical Remission at 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.
Week 12
Secondary Outcomes (5)
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
Week 12
Percentage of Participants Who Achieved Symptomatic Remission at Week 12
Week 12
Percentage of Participants Who Achieved Mucosal Healing at Week 12
Week 12
Percentage of Participants Who Achieved Clinical Response at Week 12
Week 12
Percentage of Participants Who Achieved Endoscopic Normalization at Week 12
Week 12
Other Outcomes (1)
Number of Participants With Adverse Events According to Severity
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)
Study Arms (3)
Etrasimod Dose 1
EXPERIMENTALEtrasimod Dose 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Japanese ancestry
- Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
- Having active UC confirmed by endoscopy
- Moderately to severely active UC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Arena is a wholly owned subsidiary of Pfizercollaborator
Study Sites (80)
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195, Japan
Kojunkai Daido Clinic
Nagoya, Aichi-ken, 457-8511, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570, Japan
Kojunkai Daido Hospital
Nagoya, Aixhi-ken, 457-8511, Japan
NHO Hirosaki General Medical Center
Hirosaki-shi, Aomori, 036-8545, Japan
Hirosaki University Hospital(OCT/PFT/DLCO)
Hirosaki-shi, Aomori, 036-8563, Japan
Hirosaki University Hospital
Hirosaki-shi, Aomori, 036-8563, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, 277-0871, Japan
Ishii Eye Clinic
Nagareyama-shi, Chiba, 270-0116, Japan
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741, Japan
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, 791-8026, Japan
Ehime University Hospital
Toon-shi, Ehime, 791-0295, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180, Japan
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu, Fukuoka, 806-8501, Japan
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, 802-8555, Japan
Kitakyushu Municipal Medical Center
Kitakyushu-shi, Fukuoka, 802-8561, Japan
Koyanose Eye Clinic
Kitakyushu-shi, Fukuoka, 807-1266, Japan
Our Lady of the Snow St. Mary's Hospital
Kurume, Fukuoka, 830-8543, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Kokura Memorial Hospital
Kutakyushu-shi, Fukuoka, 802-8555, Japan
Fukuoka Shinmizumaki Hospital
Onga-gun, Fukuoka, 807-0051, Japan
Gifu University Hospital
Gifu, Gifu, 501-1194, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585, Japan
Nakayama EYE Clinic
Fukuyama-shi, Hiroshima, 720-0822, Japan
NHO Fukuyama Medical Center
Fukuyama-shi, Hiroshima, 720-8520, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, 070-8610, Japan
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004-0041, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, 060-0033, Japan
NHO Mito Medical Center
Higashiibaraki-gun, Ibaraki, 311-3193, Japan
Yuai Memorial Hospital
Koga-shi, Ibaraki, 306-0232, Japan
Ibaraki Seinan Medical Center Hospital
Sashima-gun, Ibaraki, 306-0433, Japan
Matsumoto Eye Clinic
Toride-shi, Ibaraki, 302-0014, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura-shi, Ibaraki, 300-0028, Japan
NHO Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650, Japan
Kudo Internist Heart Clinic
Morioka, Iwate, 020-0871, Japan
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, 020-8505, Japan
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017, Japan
JA- Kagoshima Koseiren Hospital (PET/DLCO)
Kagoshima, Kagoshima-ken, 890-0062, Japan
Clinical Pathology Laboratory (Diagnostick center)
Kagoshima, Kagoshima-ken, 892-0813, Japan
Sameshima Eye Clinic (OCT)
Kagoshima, Kagoshima-ken, 892-0825, Japan
Sameshima Hospital
Kagoshima, Kagoshima-ken, 892-0846, Japan
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, 252-5188, Japan
Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa, 234-0054, Japan
NHO Yokohama Medical Center
Yokohama, Kanagawa, 245-8575, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Kyoto, 612-8555, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Hinaga Nishi Ophthalmology Clinic
Yokkaichi- Shi, Mie-ken, 510-0891, Japan
Mie Prefectural General Medical Center
Yokkaichi-shi, Mie-ken, 510-8561, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
JOHAS Tohoku Rosai Hospital
Sendai, Miyagi, 981-8563, Japan
Nagaoka Red Cross Hospital
Nagaoka-shi, Niigata, 940-2085, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
Medical Corporation Tokushukai Kishiwada Tokushukai Hospital
Kishiwada-shi, Osaka, 596-0042, Japan
Osaka City University Hospital
Osaka, Osaka, 545-8586, Japan
Japan Community Health care Organization Osaka Hospital
Osaka, Osaka, 553-0003, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, 569-8686, Japan
Saga University Hospital
Saga, Saga-ken, 849-8501, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495, Japan
Japan Community Health care Organization Saitama Medical Center
Saitama-shi, Saitama, 330-0074, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Matsuda Hospital
Hamamatsu, Shizuoka, 432-8061, Japan
Hamamatsu Medical Centre
Hamamatsu, Shizuoka, 432-8580, Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku, Tokyo, 113-8519, Japan
Tokai University Hachioji Hospital
Hachiōji, Tokyo, 192-0032, Japan
Showa General Hospital
Kodaira-shi, Tokyo, 187-8510, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
JCHO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, 169-0073, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
NHO Osaka National Hospital
Osaka, 540-0006, Japan
Osaka National Hospital Institutional Review Board
Osaka, 540-0006, Japan
Teikyo University Hospital
Tokyo, 173-8606, Japan
Related Publications (1)
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.
PMID: 40275818DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2021
First Posted
September 29, 2021
Study Start
September 10, 2021
Primary Completion
October 6, 2023
Study Completion
October 6, 2023
Last Updated
October 29, 2024
Results First Posted
October 29, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.