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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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ClinicalTrials.gov Identifier: NCT04706793
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Etrasimod Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 25, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Etrasimod 2 mg Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks
Other Name: APD334

Placebo Comparator: Placebo Drug: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks




Primary Outcome Measures :
  1. Proportion of Participants Achieving Clinical Remission [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Proportion of Participants Achieving Endoscopic Improvement [ Time Frame: Week 52 ]
  2. Proportion of Participants Achieving Symptomatic Remission [ Time Frame: Week 52 ]
  3. Proportion of Participants, Who had not been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 52 among Participants Receiving Corticosteroids at APD334-302 Study Entry [ Time Frame: Week 52 ]
  4. Proportion of Participants with Mucosal Healing [ Time Frame: Week 52 ]
  5. Proportion of Participants Achieving Clinical Remission [ Time Frame: Week 12 of study APD334-302 and Week 52 of study APD334-308 ]
  6. Number and Severity of Adverse Events [ Time Frame: Up to approximately 52 weeks (12 weeks in study APD334-302 and 40 weeks in study APD334-308) ]
    Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706793


Contacts
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Contact: Arena CT.gov Administrator +1 855-218-9153 ct.gov@arenapharm.com

Locations
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Japan
Koujunkai Daido Clinic Recruiting
Nagoya, Aichi, Japan, 457-8511
Toyohashi Municipal Hospital Recruiting
Toyohashi, Aichi, Japan, 441-8570
Tsujinaka Hospital Kashiwanoha Recruiting
Kashiwa-city, Chiba, Japan, 277-0871
Gifu University Hospital Recruiting
Gifu-shi, Gifu, Japan, 501-1194
NHO Kanazawa Medical Center Recruiting
Kanazawa, Ishikawa, Japan, 920-8650
Takamatsu Red Cross Hospital Recruiting
Takamatsu-shi, Kagawa-Ken, Japan, 760-0017
Jiaikai Izuro Imamura Hospital Recruiting
Kagoshima-shi, Kagoshima, Japan, 892-0824
Sameshima Hospital Recruiting
Kagoshima-shi, Kagoshima, Japan, 892-0846
Mie University Hospital Recruiting
Tsu-shi, Mie-Ken, Japan, 514-8507
JCHO Tokyo Yamate Medical Center Recruiting
Shinjuku-ku, Tokyo, Japan, 169-0073
Wakayama Medical University Hospital Recruiting
Wakayama-shi, Wakayama-ken, Japan, 641-8510
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04706793    
Other Study ID Numbers: APD334-308
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Arena Pharmaceuticals:
Ulcerative Colitis
Etrasimod
APD334
UC
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases