Clinical trial NCT04706793: Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Etrasimod
APD334
UC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Arena is a wholly owned subsidiary of Pfizer
First posted: 2021-01-13
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308
timeFrame: Week 40 of APD334-308
Secondary outcomes:
measure: Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308
timeFrame: Week 40 of APD334-308
measure: Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308
timeFrame: Week 40 of APD334-308
measure: Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308
timeFrame: Week 40 of APD334-308
measure: 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
timeFrame: Week 40 of APD334-308
measure: Percentage of Participants Achieving Sustained Clinical Remission
timeFrame: Week 40 of APD334-308
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Kojunkai Daido Clinic
state: Aichi-ken
city: Nagoya-shi
country: Japan
facility: Kojunkai Daido Hospital
state: Aichi-ken
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Toyohashi-shi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
state: Chiba
city: Nagareyama-shi
country: Japan
facility: Ishii Eye Clinic
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Takimoto Eye Clinic(OCT)
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Fakuoka Tokushukai Hospital
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu-ken
city: Ota-shi
country: Japan
facility: SUBARU Health Insurance Society Ota Memorial Hospital
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Asahikawa City Hospital
state: Hokkaido
city: Higashiibaraki-gun
country: Japan
facility: NHO Mito Medical Center
state: Ibaraki
city: Toride-shi
country: Japan
facility: Matsumoto Eye Clinic
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: NHO Kanazawa Medical Center
state: Ishikawa
city: Takamatsu-shi
country: Japan
facility: Takamatsu Red Cross Hospital
state: Kagawa
city: Takamatsu-shi
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: JA- Kagoshima Koseiren Hospital (PET/DLCO)
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Kagoshima Kouseiren Hospital
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Clinical Pathology Laboratory (Diagnostick center)
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Jiaikai Idzuro Imamura Hospital
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Sameshima Eye Clinic (OCT)
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Sameshima Hospital
state: Kagoshima
city: Kumamoto-shi
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: National Hospital Organization Kyoto Medical Center
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital
state: MIE
city: Yokkaichi-shi
country: Japan
facility: Mie Prefectural General Medical Center
state: MIE
city: Sendai-shi
country: Japan
facility: JOHAS Tohoku Rokai Hospital
state: Miyagi
city: Sendai-shi
country: Japan
facility: JOHAS Tohoku Rosai Hospital
state: Miyagi
city: Sendai-shi
country: Japan
facility: Sendai City Hospital
state: Miyagi
city: Osaka-shi
country: Japan
facility: Japan Community Health care Organization Osaka Hospital
state: Osaka
city: Saga-shi
country: Japan
facility: Saga University Hospital
state: Saga
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Kodaira-shi
country: Japan
facility: Showa General Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: JCHO Tokyo Yamate Medical Center
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: