Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
- Registration Number
- NCT04706793
- Lead Sponsor
- Pfizer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Etrasimod 2 mg Etrasimod -
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308 Week 40 of APD334-308 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Clinical Remission Week 40 of APD334-308 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.
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 Week 40 of APD334-308 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.
Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308 Week 40 of APD334-308 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.
Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308 Week 40 of APD334-308 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.
Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308 Week 40 of APD334-308 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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Trial Locations
- Locations (38)
Kojunkai Daido Clinic
🇯🇵Nagoya-shi, Aichi-ken, Japan
Kojunkai Daido Hospital
🇯🇵Nagoya-shi, Aichi-ken, Japan
Nagoya City University Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Toyohashi Municipal Hospital
🇯🇵Toyohashi-shi, Aichi, Japan
Tsujinaka Hospital Kashiwanoha
🇯🇵Kashiwa-shi, Chiba, Japan
Ishii Eye Clinic
🇯🇵Nagareyama-shi, Chiba, Japan
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Takimoto Eye Clinic(OCT)
🇯🇵Kasuga-shi, Fukuoka, Japan
Fakuoka Tokushukai Hospital
🇯🇵Kasuga-shi, Fukuoka, Japan
Gifu University Hospital
🇯🇵Gifu-shi, Gifu-ken, Japan
Scroll for more (28 remaining)Kojunkai Daido Clinic🇯🇵Nagoya-shi, Aichi-ken, Japan