Clinical Trials Logo
  1. Home
  2. Ulcerative Colitis
  3. NCT05061446
  4. Details
NCT05061446 Clinical Trial

Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05061446
Other study ID # APD334-203
Secondary ID C5041007
Status Completed
Phase Phase 2
First received
Last updated
Start date September 10, 2021
Est. completion date October 6, 2023

Study information
Verified date November 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date October 6, 2023
Est. primary completion date October 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Japan Asahikawa City Hospital Asahikawa-shi Hokkaido
Japan Tokyo Medical and Dental University Hospital Bunkyo-ku Tokyo
Japan Fukuoka University Hospital Fukuoka-shi Fukuoka
Japan Fukushima Medical University Hospital Fukushima
Japan Nakayama EYE Clinic Fukuyama-shi Hiroshima
Japan NHO Fukuyama Medical Center Fukuyama-shi Hiroshima
Japan Gifu University Hospital Gifu-shi Gifu-ken
Japan Tokai University Hachioji Hospital Hachioji Tokyo
Japan Matsuda Hospital Hamamatsu Shizuoka
Japan Hamamatsu University Hospital Hamamatsu-shi Shizuoka
Japan NHO Mito Medical Center Higashiibaraki-gun Ibaraki
Japan Kansai Medical University Hospital Hirakata-shi Osaka
Japan Hirosaki University Hospital Hirosaki-shi Aomori KEN
Japan Hirosaki University Hospital(OCT/PFT/DLCO) Hirosaki-shi Aomori KEN
Japan NHO Hirosaki National Hospital Hirosaki-shi Aomori-ken
Japan Hiroshima University Hospital Hiroshima-shi Hiroshima
Japan Saitama Medical University Hospital Iruma-gun Saitama
Japan Kagoshima University Hospital Kagoshima
Japan Clinical Pathology Laboratory (Diagnostick center) Kagoshima-shi Kagoshima
Japan JA- Kagoshima Koseiren Hospital (PET/DLCO) Kagoshima-shi Kagoshima
Japan Sameshima Eye Clinic (OCT) Kagoshima-shi Kagoshima
Japan Sameshima Hospital Kagoshima-shi Kagoshima
Japan NHO Kanazawa Medical Center Kanazawa-shi Ishikawa
Japan Tsujinaka Hospital Kashiwanoha Kashiwa-shi Chiba
Japan Medical Corporation Tokushukai Kishiwada Tokushukai Hospital Kishiwada-shi Osaka
Japan Japan Community Health Care Organization Kyushu Hospital Kitakyushu Fukuoka
Japan Kitakyushu Municipal Medical Center Kitakyushu-shi Fukuoka
Japan Koyanose Eye Clinic Kitakyushu-shi Fukuoka
Japan Showa General Hospital Kodaira-shi Tokyo
Japan Yamanashi Prefectural Central Hospital Kofu-shi Yamanashi
Japan Yuai Memorial Hospital Koga-shi Ibaraki
Japan Japanese Red Cross Kumamoto Hospital Kumamoto-shi Kumamoto
Japan Kurume University Hospital Kurume-shi Fukuoka
Japan Kokura Memorial Hospital Kutakyushu-shi Fukuoka
Japan National Hospital Organization Kyoto Medical Center Kyoto-shi Kyoto
Japan University Hospital Kyoto Prefectural University of Medicine Kyoto-shi Kyoto
Japan Saiseikai Matsuyama Hospital Matsuyama-shi Ehime
Japan Kitasato University Kitasato Institute Hospital Minato-ku Tokyo
Japan Iwate Medical University Uchimaru Medical Center Morioka-shi Iwate
Japan Aichi Medical University Hospital Nagakute Aichi
Japan Nagaoka Red Cross Hospital Nagaoka-shi Niigata
Japan Ishii Eye Clinic Nagareyama-shi Chiba
Japan Kojunkai Daido Clinic Nagoya-shi Aichi
Japan Kojunkai Daido Hospital Nagoya-shi Aixhi-ken
Japan Nagoya City University Hospital Nagoya-shi Aichi
Japan Fukuoka Shinmizumaki Hospital Onga-gun Fukuoka
Japan NHO Osaka National Hospital Osaka
Japan Osaka National Hospital Institutional Review Board Osaka
Japan Japan Community Health care Organization Osaka Hospital Osaka-shi Osaka
Japan Osaka City University Hospital Osaka-shi Osaka
Japan SUBARU Health Insurance Society Ota Memorial Hospital Ota-shi Gunma
Japan Shiga University of Medical Science Hospital Otsu Shiga
Japan Saga University Hospital Saga-shi Saga
Japan Sagamihara Kyodo Hospital Sagamihara Kanagawa
Japan Japan Community Health care Organization Saitama Medical Center Saitama-shi Saitama-ken
Japan Toho University Sakura Medical Center Sakura Chiba
Japan Sapporo-Kosei General Hospital Sapporo-shi Hokkaido
Japan Tokushukai Sapporo Tokushukai Hospital Sapporo-shi Hokkaido
Japan Ibaraki Seinan Medical Center Hospital Sashima-gun Ibaraki
Japan Tohoku University Hospital Sendai Miyagi
Japan JOHAS Tohoku Rosai Hospital Sendai-shi Miyagi
Japan JCHO Tokyo Yamate Medical Center Shinjuku-ku Tokyo
Japan Takamatsu Red Cross Hospital Takamatsu-shi Kagawa
Japan Osaka Medical and Pharmaceutical University Hospital Takatsuki-City Osaka
Japan Teikyo University Hospital Tokyo
Japan Ehime University Hospital Toon-shi Ehime
Japan Matsumoto Eye Clinic Toride-shi Ibaraki
Japan Fujita Health University Hospital Toyoake-City Aichi
Japan Toyohashi Municipal Hospital Toyohashi-shi Aichi- KEN
Japan Mie University Hospital Tsu-shi MIE
Japan Tsuchiura Kyodo General Hospital Tsuchiura-shi Ibaraki
Japan Wakayama Medical University Hospital Wakayama-shi Wakayama
Japan Hinaga Nishi Ophthalmology Clinic Yokkaichi- Shi Mie-ken
Japan Mie Prefectural General Medical Center Yokkaichi-shi Mie-ken
Japan NHO Yokohama Medical Center Yokohama-shi Kanagawa
Japan Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital Yokohama-shi Kanagawa

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Arena is a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Participants Achieving Clinical Remission Week 12
Secondary Proportion of Participants Achieving Endoscopic Improvement Week 12
Secondary Proportion of Participants Achieving Symptomatic Remission Week 12
Secondary Proportion of Participants with Mucosal Healing Week 12
Secondary Proportion of Participants Achieving Clinical Response Week 12
Secondary Proportion of Participants Achieving Endoscopic Normalization Week 12
Secondary Number and Severity of Adverse Events Safety will be assessed by monitoring adverse events and clinically significant changes in vital signs and clinical laboratory results. up to approximately 16 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05702879 - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting NCT05953402 - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Recruiting NCT03950232 - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03124121 - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels Phase 4
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Withdrawn NCT04209556 - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis Phase 2
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT04398550 - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis N/A
Recruiting NCT04314375 - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis Phase 4
Active, not recruiting NCT04857112 - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis Phase 2
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting NCT04033445 - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2/Phase 3
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting NCT06221995 - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Completed NCT03760003 - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Phase 2
Not yet recruiting NCT05539625 - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis Phase 2

External Links