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

Primary Purpose

Ulcerative Colitis

Status
Active
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Etrasimod
Etrasimod
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, APD334, Etrasimod

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toyohashi Municipal Hospital
  • Aichi Medical University Hospital
  • Kojunkai Daido Clinic
  • Nagoya City University Hospital
  • Fujita Health University Hospital
  • Kojunkai Daido Hospital
  • Hirosaki University Hospital(OCT/PFT/DLCO)
  • Hirosaki University Hospital
  • NHO Hirosaki National Hospital
  • Tsujinaka Hospital Kashiwanoha
  • Ishii Eye Clinic
  • Toho University Sakura Medical Center
  • Saiseikai Matsuyama Hospital
  • Ehime University Hospital
  • Fukuoka University Hospital
  • Kitakyushu Municipal Medical Center
  • Koyanose Eye Clinic
  • Japan Community Health Care Organization Kyushu Hospital
  • Kurume University Hospital
  • Kokura Memorial Hospital
  • Fukuoka Shinmizumaki Hospital
  • Gifu University Hospital
  • SUBARU Health Insurance Society Ota Memorial Hospital
  • Nakayama EYE Clinic
  • NHO Fukuyama Medical Center
  • Hiroshima University Hospital
  • Asahikawa City Hospital
  • Tokushukai Sapporo Tokushukai Hospital
  • Sapporo-Kosei General Hospital
  • NHO Mito Medical Center
  • Yuai Memorial Hospital
  • Ibaraki Seinan Medical Center Hospital
  • Matsumoto Eye Clinic
  • Tsuchiura Kyodo General Hospital
  • NHO Kanazawa Medical Center
  • Iwate Medical University Uchimaru Medical Center
  • Takamatsu Red Cross Hospital
  • JA- Kagoshima Koseiren Hospital (PET/DLCO)
  • Clinical Pathology Laboratory (Diagnostick center)
  • Sameshima Eye Clinic (OCT)
  • Sameshima Hospital
  • Sagamihara Kyodo Hospital
  • Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
  • NHO Yokohama Medical Center
  • Japanese Red Cross Kumamoto Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • National Hospital Organization Kyoto Medical Center
  • Hinaga Nishi Ophthalmology Clinic
  • Mie Prefectural General Medical Center
  • Mie University Hospital
  • JOHAS Tohoku Rosai Hospital
  • Tohoku University Hospital
  • Nagaoka Red Cross Hospital
  • Kansai Medical University Hospital
  • Medical Corporation Tokushukai Kishiwada Tokushukai Hospital
  • Osaka City University Hospital
  • Japan Community Health care Organization Osaka Hospital
  • Osaka Medical and Pharmaceutical University Hospital
  • Saga University Hospital
  • Japan Community Health care Organization Saitama Medical Center
  • Saitama Medical University Hospital
  • Shiga University of Medical Science Hospital
  • Hamamatsu University Hospital
  • Matsuda Hospital
  • Tokyo Medical and Dental University Hospital
  • Tokai University Hachioji Hospital
  • Showa General Hospital
  • Kitasato University Kitasato Institute Hospital
  • JCHO Tokyo Yamate Medical Center
  • Wakayama Medical University Hospital
  • Yamanashi Prefectural Central Hospital
  • Fukushima Medical University Hospital
  • Kagoshima University Hospital
  • NHO Osaka National Hospital
  • Osaka National Hospital Institutional Review Board
  • Teikyo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Etrasimod Dose 1

Etrasimod Dose 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Participants Achieving Clinical Remission

Secondary Outcome Measures

Proportion of Participants Achieving Endoscopic Improvement
Proportion of Participants Achieving Symptomatic Remission
Proportion of Participants with Mucosal Healing
Proportion of Participants Achieving Clinical Response
Proportion of Participants Achieving Endoscopic Normalization
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.

Full Information

First Posted
September 20, 2021
Last Updated
September 6, 2023
Sponsor
Pfizer
Collaborators
Arena is a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05061446
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Arena is a wholly owned subsidiary of Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, APD334, Etrasimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etrasimod Dose 1
Arm Type
Experimental
Arm Title
Etrasimod Dose 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Etrasimod
Other Intervention Name(s)
APD334
Intervention Description
Etrasimod tablet by mouth, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Etrasimod
Other Intervention Name(s)
APD334
Intervention Description
Etrasimod tablet by mouth, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks
Primary Outcome Measure Information:
Title
Proportion of Participants Achieving Clinical Remission
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of Participants Achieving Endoscopic Improvement
Time Frame
Week 12
Title
Proportion of Participants Achieving Symptomatic Remission
Time Frame
Week 12
Title
Proportion of Participants with Mucosal Healing
Time Frame
Week 12
Title
Proportion of Participants Achieving Clinical Response
Time Frame
Week 12
Title
Proportion of Participants Achieving Endoscopic Normalization
Time Frame
Week 12
Title
Number and Severity of Adverse Events
Description
Safety will be assessed by monitoring adverse events and clinically significant changes in vital signs and clinical laboratory results.
Time Frame
up to approximately 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Toyohashi Municipal Hospital
City
Toyohashi-shi
State/Province
Aichi- KEN
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Kojunkai Daido Clinic
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake-City
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Kojunkai Daido Hospital
City
Nagoya-shi
State/Province
Aixhi-ken
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Hirosaki University Hospital(OCT/PFT/DLCO)
City
Hirosaki-shi
State/Province
Aomori KEN
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Hirosaki University Hospital
City
Hirosaki-shi
State/Province
Aomori KEN
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
NHO Hirosaki National Hospital
City
Hirosaki-shi
State/Province
Aomori-ken
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Tsujinaka Hospital Kashiwanoha
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-0871
Country
Japan
Facility Name
Ishii Eye Clinic
City
Nagareyama-shi
State/Province
Chiba
ZIP/Postal Code
270-0116
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Saiseikai Matsuyama Hospital
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-8026
Country
Japan
Facility Name
Ehime University Hospital
City
Toon-shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Kitakyushu Municipal Medical Center
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
802-8561
Country
Japan
Facility Name
Koyanose Eye Clinic
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
807-1266
Country
Japan
Facility Name
Japan Community Health Care Organization Kyushu Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kutakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Fukuoka Shinmizumaki Hospital
City
Onga-gun
State/Province
Fukuoka
ZIP/Postal Code
807-0051
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu-shi
State/Province
Gifu-ken
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
SUBARU Health Insurance Society Ota Memorial Hospital
City
Ota-shi
State/Province
Gunma
ZIP/Postal Code
373-8585
Country
Japan
Facility Name
Nakayama EYE Clinic
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-0822
Country
Japan
Facility Name
NHO Fukuyama Medical Center
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Asahikawa City Hospital
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8610
Country
Japan
Facility Name
Tokushukai Sapporo Tokushukai Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Sapporo-Kosei General Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
NHO Mito Medical Center
City
Higashiibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Yuai Memorial Hospital
City
Koga-shi
State/Province
Ibaraki
ZIP/Postal Code
306-0232
Country
Japan
Facility Name
Ibaraki Seinan Medical Center Hospital
City
Sashima-gun
State/Province
Ibaraki
ZIP/Postal Code
306-0433
Country
Japan
Facility Name
Matsumoto Eye Clinic
City
Toride-shi
State/Province
Ibaraki
ZIP/Postal Code
302-0014
Country
Japan
Facility Name
Tsuchiura Kyodo General Hospital
City
Tsuchiura-shi
State/Province
Ibaraki
ZIP/Postal Code
300-0028
Country
Japan
Facility Name
NHO Kanazawa Medical Center
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Iwate Medical University Uchimaru Medical Center
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Takamatsu Red Cross Hospital
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
JA- Kagoshima Koseiren Hospital (PET/DLCO)
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0062
Country
Japan
Facility Name
Clinical Pathology Laboratory (Diagnostick center)
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0813
Country
Japan
Facility Name
Sameshima Eye Clinic (OCT)
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0825
Country
Japan
Facility Name
Sameshima Hospital
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Sagamihara Kyodo Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-5188
Country
Japan
Facility Name
Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
234-0054
Country
Japan
Facility Name
NHO Yokohama Medical Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
National Hospital Organization Kyoto Medical Center
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Hinaga Nishi Ophthalmology Clinic
City
Yokkaichi- Shi
State/Province
Mie-ken
ZIP/Postal Code
510-0891
Country
Japan
Facility Name
Mie Prefectural General Medical Center
City
Yokkaichi-shi
State/Province
Mie-ken
ZIP/Postal Code
510-8561
Country
Japan
Facility Name
Mie University Hospital
City
Tsu-shi
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
JOHAS Tohoku Rosai Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Nagaoka Red Cross Hospital
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Kansai Medical University Hospital
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Medical Corporation Tokushukai Kishiwada Tokushukai Hospital
City
Kishiwada-shi
State/Province
Osaka
ZIP/Postal Code
596-0042
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Japan Community Health care Organization Osaka Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki-City
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saga University Hospital
City
Saga-shi
State/Province
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Japan Community Health care Organization Saitama Medical Center
City
Saitama-shi
State/Province
Saitama-ken
ZIP/Postal Code
330-0074
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Matsuda Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
432-8061
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Tokai University Hachioji Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Showa General Hospital
City
Kodaira-shi
State/Province
Tokyo
ZIP/Postal Code
187-8510
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
JCHO Tokyo Yamate Medical Center
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu-shi
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
NHO Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka National Hospital Institutional Review Board
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Teikyo University Hospital
City
Tokyo
ZIP/Postal Code
173-8606
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=APD334-203
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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