Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)

Sponsor

Arena Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04706793

Collaborator

(none)

Enrollment

Locations

Arms

20.2

Anticipated Duration (Months)

1.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

42 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 :

Dec 25, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Etrasimod 2 mg	Drug: Etrasimod Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks Other Names: APD334
Placebo Comparator: Placebo	Drug: Placebo Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks

Arm

Intervention/Treatment

Experimental: Etrasimod 2 mg

Drug: Etrasimod

Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks

Other Names:

APD334

Placebo Comparator: Placebo

Drug: Placebo

Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks

Outcome Measures

Primary Outcome Measures

Proportion of Participants Achieving Clinical Remission [Week 52]

Secondary Outcome Measures

Proportion of Participants Achieving Endoscopic Improvement [Week 52]
Proportion of Participants Achieving Symptomatic Remission [Week 52]
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 [Week 52]
Proportion of Participants with Mucosal Healing [Week 52]
Proportion of Participants Achieving Clinical Remission [Week 12 of study APD334-302 and Week 52 of study APD334-308]
Number and Severity of Adverse Events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nagoya City University Hospital	Nagoya-shi	Aichi	Japan	467-8602
2	Koujunkai Daido Clinic	Nagoya	Aichi	Japan	457-8511
3	Toyohashi Municipal Hospital	Toyohashi	Aichi	Japan	441-8570
4	Tsujinaka Hospital Kashiwanoha	Kashiwa-city	Chiba	Japan	277-0871
5	Fukuoka University Hospital	Fukuoka-shi	Fukuoka	Japan	814-0180
6	Fukuoka Tokushukai Hospital	Kasuga-shi	Fukuoka	Japan	816-0864
7	Gifu University Hospital	Gifu-shi	Gifu	Japan	501-1194
8	SUBARU Health Insurance Society Ota Memorial Hospital	Ota-shi	Gunma	Japan	373-8585
9	Hiroshima University Hospital	Hiroshima-shi	Hiroshima	Japan	734-8551
10	Asahikawa City Hospital	Asahikawa-shi	Hokkaido	Japan	070-8610
11	NHO Mito Medical Center	Higashi	Ibaraki	Japan	311-3193
12	NHO Kanazawa Medical Center	Kanazawa	Ishikawa	Japan	920-8650
13	Iwate Medical University Uchimaru Medical Center	Morioka-shi	Iwate	Japan	020-8505
14	Takamatsu Red Cross Hospital	Takamatsu-shi	Kagawa-Ken	Japan	760-0017
15	Kagawa Prefectural Central Hospital	Takamatsu	Kagawa	Japan	760-8557
16	Jiaikai Izuro Imamura Hospital	Kagoshima-shi	Kagoshima	Japan	892-0824
17	Sameshima Hospital	Kagoshima-shi	Kagoshima	Japan	892-0846
18	Japanese Red Cross Kumamoto Hospital	Kumamoto-shi	Kumamoto	Japan	861-8520
19	NHO Kyoto Medical Center	Kyoto-shi	Kyoto	Japan	612-8555
20	Mie University Hospital	Tsu-shi	Mie-Ken	Japan	514-8507
21	Local Independent Administrative Institution Mie Prefectural General Medical Center	Yokkaichi-shi	Mie	Japan	510-8561
22	JOHAS Tohoku Rosai Hospital	Sendai-shi	Miyagi	Japan	981-8563
23	Sendai City Hospital	Sendai-shi	Miyagi	Japan	982-8502
24	Japan Community Health care Organization Osaka Hospital	Fukushima	Osaka	Japan	553-0003
25	Saga University Hospital	Saga-shi	Saga	Japan	849-8501
26	St. Luke's International Hospital	Chuo-ku	Tokyo	Japan	104-8560
27	Showa General Hospital	Kodaira-shi	Tokyo	Japan	187-0002
28	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo	Japan	108-8642
29	JCHO Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo	Japan	169-0073
30	Wakayama Medical University Hospital	Wakayama-shi	Wakayama-ken	Japan	641-8510