Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
2 other identifiers
interventional
42
1 country
38
Brief Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will continue with the same blinded treatment assigned in Study APD334-302 for a total treatment duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2020
38 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
December 25, 2020
CompletedFirst Submitted
Initial submission to the registry
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2022
CompletedResults Posted
Study results publicly available
October 16, 2023
CompletedOctober 16, 2023
September 1, 2023
1.6 years
January 11, 2021
August 2, 2023
September 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308
Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Week 40 of APD334-308
Secondary Outcomes (5)
Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308
Week 40 of APD334-308
Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308
Week 40 of APD334-308
Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308
Week 40 of APD334-308
Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry
Week 40 of APD334-308
Percentage of Participants Achieving Sustained Clinical Remission
Week 40 of APD334-308
Study Arms (2)
Etrasimod 2 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Participants with moderately to severely active ulcerative colitis (UC) are eligible to enroll into this study if they fulfill all of the following:
- Must have completed the Week 12 visit of Study APD334-302
- Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a participant \< 20 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of participants \< 20 years should be conducted only if acceptable according to local laws and regulations.
- Both men and women subjects agree to use a highly effective method of birth control if the possibility of conception exists
You may not qualify if:
- If the Investigator considers the participant to be unsuitable for any reason to participate in the study
- Participants requiring partial or total colectomy during the APD334-302 study
- Participants requiring treatment with prohibited concomitant medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Arena is a wholly owned subsidiary of Pfizercollaborator
Study Sites (38)
Kojunkai Daido Clinic
Nagoya, Aichi-ken, 457-8511, Japan
Kojunkai Daido Hospital
Nagoya, Aichi-ken, 457-8511, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, 277-0871, Japan
Ishii Eye Clinic
Nagareyama-shi, Chiba, 270-0116, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180, Japan
Takimoto Eye Clinic(OCT)
Kasuga-shi, Fukuoka, 816-0863, Japan
Fakuoka Tokushukai Hospital
Kasuga-shi, Fukuoka, 816-0864, Japan
Gifu University Hospital
Gifu, Gifu, 501-1194, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, 070-8610, Japan
NHO Mito Medical Center
Higashiibaraki-gun, Ibaraki, 311-3193, Japan
Matsumoto Eye Clinic
Toride-shi, Ibaraki, 302-0014, Japan
NHO Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650, Japan
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557, Japan
JA- Kagoshima Koseiren Hospital (PET/DLCO)
Kagoshima, Kagoshima-ken, 890-0062, Japan
Kagoshima Kouseiren Hospital
Kagoshima, Kagoshima-ken, 890-0062, Japan
Clinical Pathology Laboratory (Diagnostick center)
Kagoshima, Kagoshima-ken, 892-0813, Japan
Jiaikai Idzuro Imamura Hospital
Kagoshima, Kagoshima-ken, 892-0824, Japan
Sameshima Eye Clinic (OCT)
Kagoshima, Kagoshima-ken, 892-0825, Japan
Sameshima Hospital
Kagoshima, Kagoshima-ken, 892-0846, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Kyoto, 612-8555, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Mie Prefectural General Medical Center
Yokkaichi-shi, Mie-ken, 510-8561, Japan
JOHAS Tohoku Rokai Hospital
Sendai, Miyagi, 981-8563, Japan
JOHAS Tohoku Rosai Hospital
Sendai, Miyagi, 981-8563, Japan
Sendai City Hospital
Sendai, Miyagi, 982-8502, Japan
Japan Community Health care Organization Osaka Hospital
Osaka, Osaka, 553-0003, Japan
Saga University Hospital
Saga, Saga-ken, 849-8501, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560, 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
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 13, 2021
Study Start
December 25, 2020
Primary Completion
August 3, 2022
Study Completion
August 3, 2022
Last Updated
October 16, 2023
Results First Posted
October 16, 2023
Record last verified: 2023-09
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.