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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)
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
Secondary ID [1] 0 0
C5041013
Secondary ID [2] 0 0
APD334-308
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308
Timepoint [1] 0 0
Week 40 of APD334-308
Secondary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308
Timepoint [1] 0 0
Week 40 of APD334-308
Secondary outcome [2] 0 0
Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308
Timepoint [2] 0 0
Week 40 of APD334-308
Secondary outcome [3] 0 0
Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308
Timepoint [3] 0 0
Week 40 of APD334-308
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 40 of APD334-308
Secondary outcome [5] 0 0
Percentage of Participants Achieving Sustained Clinical Remission
Timepoint [5] 0 0
Week 40 of APD334-308

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
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2022
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Aichi-ken
Country [2] 0 0
Japan
State/province [2] 0 0
Aichi
Country [3] 0 0
Japan
State/province [3] 0 0
Chiba
Country [4] 0 0
Japan
State/province [4] 0 0
Fukuoka
Country [5] 0 0
Japan
State/province [5] 0 0
Gifu-ken
Country [6] 0 0
Japan
State/province [6] 0 0
Gunma
Country [7] 0 0
Japan
State/province [7] 0 0
Hiroshima
Country [8] 0 0
Japan
State/province [8] 0 0
Hokkaido
Country [9] 0 0
Japan
State/province [9] 0 0
Ibaraki
Country [10] 0 0
Japan
State/province [10] 0 0
Ishikawa
Country [11] 0 0
Japan
State/province [11] 0 0
Kagawa
Country [12] 0 0
Japan
State/province [12] 0 0
Kagoshima
Country [13] 0 0
Japan
State/province [13] 0 0
Kumamoto
Country [14] 0 0
Japan
State/province [14] 0 0
Kyoto
Country [15] 0 0
Japan
State/province [15] 0 0
MIE
Country [16] 0 0
Japan
State/province [16] 0 0
Miyagi
Country [17] 0 0
Japan
State/province [17] 0 0
Osaka
Country [18] 0 0
Japan
State/province [18] 0 0
Saga
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
Japan
State/province [20] 0 0
Wakayama

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Arena is a wholly owned subsidiary of Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04706793
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries