Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
- Registration Number
- NCT05061446
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Japanese ancestry
- Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
- Having active UC confirmed by endoscopy
- Moderately to severely active UC
- Severe extensive colitis
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Etrasimod Dose 1 Etrasimod - Placebo Placebo - Etrasimod Dose 2 Etrasimod -
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Clinical Remission at Week 12 Week 12 Clinical remission:Participants with stool frequency (SF)subscore=0(or of 1 with greater than or equal to(\>=)1 point decrease from baseline,rectal bleeding(RB)subscore=0 and endoscopic score(ES)less than or equal to(\<)=1(excluding friability).SF subscore:number of stools in 24-hours relative to normal number of stools for that participant in same period,score ranged from 0(normal number of stools) to 3(5 or more stools than normal),higher scores=more severity.RB subscore:most severe amount of blood passed per rectum in 24-hours,score ranged from 0(no blood seen)to 3(blood alone passes),higher scores=more severity.ES:reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,score ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding,ulceration\]),higher scores=more severity.Modified Mayo score:measure disease activity for UC,score:0(normal) to 9(maximum severity),comprised subscores for SF,RB,ES.higher score=more severe disease activity.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 Week 12 Endoscopic improvement was defined as ES \<= 1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity),and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.
Percentage of Participants Who Achieved Symptomatic Remission at Week 12 Week 12 Symptomatic remission was defined as SF sub score = 0 (or = 1 with a \>= 1 point decrease from baseline) and RB sub score = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.
Percentage of Participants Who Achieved Mucosal Healing at Week 12 Week 12 Mucosal healing was defined as ES \<= 1 (excluding friability) with histologic remission defined as a Geboes index score \< 2.0). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. 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. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), comprised subscores for SF, RB, ES. Higher score = more severe disease activity.
Percentage of Participants Who Achieved Clinical Response at Week 12 Week 12 Clinical response was defined as a \>= 2-point and \>= 30 percentage (%) decrease from baseline in MMS, and a \>= 1-point decrease from baseline in RB subscore or an absolute RB subscore \<= 1. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity.
Percentage of Participants Who Achieved Endoscopic Normalization at Week 12 Week 12 Endoscopic normalization was defined as ES= 0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity.
Trial Locations
- Locations (79)
NHO Hirosaki General Medical Center
🇯🇵Hirosaki-shi, Aomori-ken, Japan
Our Lady of the Snow St. Mary's Hospital
🇯🇵Kurume, Fukuoka, Japan
Kudo Internist Heart Clinic
🇯🇵Morioka-shi, Iwate-ken, Japan
Hamamatsu Medical Centre
🇯🇵Hamamatsu-shi, Shizuoka-ken, Japan
Toyohashi Municipal Hospital
🇯🇵Toyohashi-shi, Aichi- KEN, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Aichi, Japan
Kojunkai Daido Clinic
🇯🇵Nagoya-shi, Aichi, Japan
Nagoya City University Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Fujita Health University Hospital
🇯🇵Toyoake-City, Aichi, Japan
Kojunkai Daido Hospital
🇯🇵Nagoya-shi, Aixhi-ken, Japan
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