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| ID | Type | Description | Link |
|---|---|---|---|
| C5041007 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Arena is a wholly owned subsidiary of Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etrasimod Dose 1 | Experimental |
| |
| Etrasimod Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod | Drug | Etrasimod tablet by mouth, once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Remission at 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Endoscopic Improvement at 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events According to Severity | An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity was classified using common terminology criteria for adverse events (CTCAE), version 5.0, such as Grade 1 for mild, Grade 2 for moderate, Grade 3 for severe, Grade 4 for life-threatening, Grade 5 for death related to adverse event. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital | Nagakute | Aichi-ken | 480-1195 | Japan | ||
| Kojunkai Daido Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40275818 | Derived | Takeuchi K, Nakase H, Hisamatsu T, Matsuoka K, Arai S, Yuasa H, Oe M, Ono R, Keating M, Gu G, Lazin K, McDonnell A, Fukuta K, Hibi T. Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study. Intest Res. 2026 Apr;24(2):352-365. doi: 10.5217/ir.2024.00213. Epub 2025 Apr 25. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 54 Japanese participants with moderate to severely active ulcerative colitis (UC) were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to etrasimod once daily, orally for 12 weeks. |
| FG001 | Etrasimod 1 mg | Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2023 | Oct 3, 2024 |
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| Etrasimod | Drug | Etrasimod tablet by mouth, once daily for 12 weeks |
|
|
| Placebo | Drug | Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks |
|
| Week 12 |
| Percentage of Participants Who Achieved Symptomatic Remission at 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. | Week 12 |
| Percentage of Participants Who Achieved Mucosal Healing at 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. | Week 12 |
| Percentage of Participants Who Achieved Clinical Response at 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. | Week 12 |
| Percentage of Participants Who Achieved Endoscopic Normalization at 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. | Week 12 |
| Day 1 of first dose of study treatment up to 4 weeks after administration of the final dose of study treatment (maximum up to 16 weeks) |
| Nagoya |
| Aichi-ken |
| 457-8511 |
| Japan |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| Fujita Health University Hospital | Toyoake | Aichi-ken | 470-1192 | Japan |
| Toyohashi Municipal Hospital | Toyohashi | Aichi-ken | 441-8570 | Japan |
| Kojunkai Daido Hospital | Nagoya | Aixhi-ken | 457-8511 | Japan |
| NHO Hirosaki General Medical Center | Hirosaki-shi | Aomori | 036-8545 | Japan |
| Hirosaki University Hospital(OCT/PFT/DLCO) | Hirosaki-shi | Aomori | 036-8563 | Japan |
| Hirosaki University Hospital | Hirosaki-shi | Aomori | 036-8563 | Japan |
| Tsujinaka Hospital Kashiwanoha | Kashiwa-shi | Chiba | 277-0871 | Japan |
| Ishii Eye Clinic | Nagareyama-shi | Chiba | 270-0116 | Japan |
| Toho University Sakura Medical Center | Sakura | Chiba | 285-8741 | Japan |
| Saiseikai Matsuyama Hospital | Matsuyama | Ehime | 791-8026 | Japan |
| Ehime University Hospital | Toon-shi | Ehime | 791-0295 | Japan |
| Fukuoka University Hospital | Fukuoka | Fukuoka | 814-0180 | Japan |
| Japan Community Health Care Organization Kyushu Hospital | Kitakyushu | Fukuoka | 806-8501 | Japan |
| Kokura Memorial Hospital | Kitakyushu-shi | Fukuoka | 802-8555 | Japan |
| Kitakyushu Municipal Medical Center | Kitakyushu-shi | Fukuoka | 802-8561 | Japan |
| Koyanose Eye Clinic | Kitakyushu-shi | Fukuoka | 807-1266 | Japan |
| Our Lady of the Snow St. Mary's Hospital | Kurume | Fukuoka | 830-8543 | Japan |
| Kurume University Hospital | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Kokura Memorial Hospital | Kutakyushu-shi | Fukuoka | 802-8555 | Japan |
| Fukuoka Shinmizumaki Hospital | Onga-gun | Fukuoka | 807-0051 | Japan |
| Gifu University Hospital | Gifu | Gifu | 501-1194 | Japan |
| SUBARU Health Insurance Society Ota Memorial Hospital | Ota-shi | Gunma | 373-8585 | Japan |
| Nakayama EYE Clinic | Fukuyama-shi | Hiroshima | 720-0822 | Japan |
| NHO Fukuyama Medical Center | Fukuyama-shi | Hiroshima | 720-8520 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Asahikawa City Hospital | Asahikawa-shi | Hokkaido | 070-8610 | Japan |
| Tokushukai Sapporo Tokushukai Hospital | Sapporo | Hokkaido | 004-0041 | Japan |
| Sapporo-Kosei General Hospital | Sapporo | Hokkaido | 060-0033 | Japan |
| NHO Mito Medical Center | Higashiibaraki-gun | Ibaraki | 311-3193 | Japan |
| Yuai Memorial Hospital | Koga-shi | Ibaraki | 306-0232 | Japan |
| Ibaraki Seinan Medical Center Hospital | Sashima-gun | Ibaraki | 306-0433 | Japan |
| Matsumoto Eye Clinic | Toride-shi | Ibaraki | 302-0014 | Japan |
| Tsuchiura Kyodo General Hospital | Tsuchiura-shi | Ibaraki | 300-0028 | Japan |
| NHO Kanazawa Medical Center | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Kudo Internist Heart Clinic | Morioka | Iwate | 020-0871 | Japan |
| Iwate Medical University Uchimaru Medical Center | Morioka | Iwate | 020-8505 | Japan |
| Takamatsu Red Cross Hospital | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| JA- Kagoshima Koseiren Hospital (PET/DLCO) | Kagoshima | Kagoshima-ken | 890-0062 | Japan |
| Clinical Pathology Laboratory (Diagnostick center) | Kagoshima | Kagoshima-ken | 892-0813 | Japan |
| Sameshima Eye Clinic (OCT) | Kagoshima | Kagoshima-ken | 892-0825 | Japan |
| Sameshima Hospital | Kagoshima | Kagoshima-ken | 892-0846 | Japan |
| Sagamihara Kyodo Hospital | Sagamihara | Kanagawa | 252-5188 | Japan |
| Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital | Yokohama | Kanagawa | 234-0054 | Japan |
| NHO Yokohama Medical Center | Yokohama | Kanagawa | 245-8575 | Japan |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | Kumamoto | 861-8520 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | Kyoto | 602-8566 | Japan |
| National Hospital Organization Kyoto Medical Center | Kyoto | Kyoto | 612-8555 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| Hinaga Nishi Ophthalmology Clinic | Yokkaichi- Shi | Mie-ken | 510-0891 | Japan |
| Mie Prefectural General Medical Center | Yokkaichi-shi | Mie-ken | 510-8561 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| JOHAS Tohoku Rosai Hospital | Sendai | Miyagi | 981-8563 | Japan |
| Nagaoka Red Cross Hospital | Nagaoka-shi | Niigata | 940-2085 | Japan |
| Kansai Medical University Hospital | Hirakata-shi | Osaka | 573-1191 | Japan |
| Medical Corporation Tokushukai Kishiwada Tokushukai Hospital | Kishiwada-shi | Osaka | 596-0042 | Japan |
| Osaka City University Hospital | Osaka | Osaka | 545-8586 | Japan |
| Japan Community Health care Organization Osaka Hospital | Osaka | Osaka | 553-0003 | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki | Osaka | 569-8686 | Japan |
| Saga University Hospital | Saga | Saga-ken | 849-8501 | Japan |
| Saitama Medical University Hospital | Iruma-gun | Saitama | 350-0495 | Japan |
| Japan Community Health care Organization Saitama Medical Center | Saitama-shi | Saitama | 330-0074 | Japan |
| Shiga University of Medical Science Hospital | Ōtsu | Shiga | 520-2192 | Japan |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Matsuda Hospital | Hamamatsu | Shizuoka | 432-8061 | Japan |
| Hamamatsu Medical Centre | Hamamatsu | Shizuoka | 432-8580 | Japan |
| Tokyo Medical and Dental University Hospital | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Tokai University Hachioji Hospital | Hachiōji | Tokyo | 192-0032 | Japan |
| Showa General Hospital | Kodaira-shi | Tokyo | 187-8510 | Japan |
| Kitasato University Kitasato Institute Hospital | Minato-ku | Tokyo | 108-8642 | Japan |
| JCHO Tokyo Yamate Medical Center | Shinjuku-ku | Tokyo | 169-0073 | Japan |
| Wakayama Medical University Hospital | Wakayama | Wakayama | 641-8510 | Japan |
| Yamanashi Prefectural Central Hospital | Kofu | Yamanashi | 400-8506 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| Kagoshima University Hospital | Kagoshima | 890-8520 | Japan |
| NHO Osaka National Hospital | Osaka | 540-0006 | Japan |
| Osaka National Hospital Institutional Review Board | Osaka | 540-0006 | Japan |
| Teikyo University Hospital | Tokyo | 173-8606 | Japan |
| FG002 | Etrasimod 2 mg | Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to etrasimod once daily, orally for 12 weeks. |
| BG001 | Etrasimod 1 mg | Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks. |
| BG002 | Etrasimod 2 mg | Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Clinical Remission at 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. | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, "number of participants analyzed" signifies only those participants who had a baseline MMS score between 5 and 9. | Posted | Number | Percentage of participants | Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Endoscopic Improvement at 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. | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, "number of participants analyzed" signifies only those participants who had a baseline MMS score between 5 and 9. | Posted | Number | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Symptomatic Remission at 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. | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, "number of participants analyzed" signifies only those participants who had a baseline MMS score between 5 and 9. | Posted | Number | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Mucosal Healing at 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. | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, "number of participants analyzed" signifies only those participants who had a baseline MMS score between 5 and 9. | Posted | Number | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Clinical Response at 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. | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, "number of participants analyzed" signifies only those participants who had a baseline MMS score between 5 and 9. | Posted | Number | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Endoscopic Normalization at 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. | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, "number of participants analyzed" signifies only those participants who had a baseline MMS score between 5 and 9. | Posted | Number | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Adverse Events According to Severity | An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity was classified using common terminology criteria for adverse events (CTCAE), version 5.0, such as Grade 1 for mild, Grade 2 for moderate, Grade 3 for severe, Grade 4 for life-threatening, Grade 5 for death related to adverse event. | The safety set included all randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Day 1 of first dose of study treatment up to 4 weeks after administration of the final dose of study treatment (maximum up to 16 weeks) |
|
Day 1 of first dose of study treatment up to 4 weeks after administration of the final dose of study treatment (maximum up to 16 weeks)
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to etrasimod once daily, orally for 12 weeks. | 0 | 18 | 0 | 18 | 10 | 18 |
| EG001 | Etrasimod 1 mg | Participants received etrasimod 1 milligram (mg) tablets once daily, orally for 12 weeks. | 0 | 17 | 0 | 17 | 9 | 17 |
| EG002 | Etrasimod 2 mg | Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks. | 0 | 19 | 0 | 19 | 13 | 19 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vaccination site joint pain | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Epiretinal membrane | Eye disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2023 | Oct 3, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656249 | etrasimod |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Difference in percentage |
| 26.3 |
| 2-Sided |
| 95 |
| 6.52 |
| 46.12 |
| Other |
|
|
|
| Etrasimod 2 mg |
Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks. |
|
|
|
| OG002 | Etrasimod 2 mg | Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants received etrasimod 2 mg tablets once daily, orally for 12 weeks. |
|
|