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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04706793
Registration number
NCT04706793
Ethics application status
Date submitted
11/01/2021
Date registered
13/01/2021
Date last updated
16/10/2023
Titles & IDs
Public title
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
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Scientific title
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
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Secondary ID [1]
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C5041013
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Secondary ID [2]
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APD334-308
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo
Experimental: Etrasimod 2 mg -
Placebo Comparator: Placebo -
Treatment: Drugs: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks
Treatment: Drugs: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308
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Assessment method [1]
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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.
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Timepoint [1]
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Week 40 of APD334-308
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Secondary outcome [1]
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Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308
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Assessment method [1]
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Endoscopic improvement was defined as an ES <=1 (excluding friability) at Week 40 of APD334-308 compared with Week 12 of APD334-302. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease.
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Timepoint [1]
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Week 40 of APD334-308
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Secondary outcome [2]
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Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308
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Assessment method [2]
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Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
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Timepoint [2]
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Week 40 of APD334-308
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Secondary outcome [3]
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Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308
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Assessment method [3]
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Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). 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.
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Timepoint [3]
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Week 40 of APD334-308
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Secondary outcome [4]
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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
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Assessment method [4]
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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.
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Timepoint [4]
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Week 40 of APD334-308
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Secondary outcome [5]
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Percentage of Participants Achieving Sustained Clinical Remission
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Assessment method [5]
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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. A subject with sustained clinical remission is defined as someone who achieved clinical remission at both Week 12 of APD334-302 and Week 40 of APD334-308.
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Timepoint [5]
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Week 40 of APD334-308
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Eligibility
Key inclusion criteria
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
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Minimum age
16
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants who meet any of the following exclusion criteria will not be eligible for
enrollment into the study:
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/08/2022
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Sample size
Target
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Japan
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State/province [1]
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Aichi-ken
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Country [2]
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Japan
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State/province [2]
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Aichi
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Country [3]
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Japan
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State/province [3]
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Chiba
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Country [4]
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Japan
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State/province [4]
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Fukuoka
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Country [5]
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Japan
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State/province [5]
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Gifu-ken
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Country [6]
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Japan
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State/province [6]
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Gunma
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Country [7]
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Japan
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State/province [7]
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Hiroshima
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Country [8]
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Japan
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State/province [8]
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Hokkaido
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Country [9]
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Japan
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State/province [9]
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Ibaraki
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Country [10]
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Japan
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State/province [10]
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Ishikawa
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Country [11]
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Japan
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State/province [11]
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Kagawa
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Country [12]
0
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Japan
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State/province [12]
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Kagoshima
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Country [13]
0
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Japan
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State/province [13]
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Kumamoto
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Country [14]
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Japan
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State/province [14]
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Kyoto
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Country [15]
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Japan
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State/province [15]
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MIE
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Country [16]
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Japan
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State/province [16]
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Miyagi
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Country [17]
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Japan
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State/province [17]
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Osaka
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Country [18]
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Japan
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State/province [18]
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Saga
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Country [19]
0
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Japan
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State/province [19]
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Tokyo
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Country [20]
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Japan
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State/province [20]
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Wakayama
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04706793
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT04706793
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