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| ID | Type | Description | Link |
|---|---|---|---|
| C5041013 | 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 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etrasimod 2 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod | Drug | Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission at Week 40 of Study 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. | Week 40 of APD334-308 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study 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. | Week 40 of APD334-308 |
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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:
Exclusion Criteria:
Participants who meet any of the following exclusion criteria will not be eligible for enrollment into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kojunkai Daido Clinic | Nagoya | Aichi-ken | 457-8511 | Japan | ||
| Kojunkai Daido Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42248437 | Derived | Danese S, Goetsch M, Peyrin-Biroulet L, Yarur AJ, Dubinsky M, Rubin DT, Feagan BG, D'Haens G, Baert F, Lazin K, Gu G, Yu J, Lawendy N, Zang C, Wang W, Menon S, Law EH, Modesto I, Wosik K, Sidhu S, Niezychowski W, Vermeire S. The Efficacy and Safety of Etrasimod in Mildly to Moderately Active Ulcerative Colitis: Results From the Phase II GLADIATOR Trial. Clin Gastroenterol Hepatol. 2026 Jun 4:S1542-3565(26)00405-2. doi: 10.1016/j.cgh.2026.05.024. Online ahead of print. |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Comparator: Placebo | Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308 |
| FG001 | Experimental: Etrasimod 2 mg | Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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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 | Apr 15, 2020 | Jul 14, 2023 |
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| Placebo | Drug | Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks |
|
| Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study 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. | Week 40 of APD334-308 |
| Percentage of Participants With Mucosal Healing at Week 40 of Study 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. | 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 | 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. | Week 40 of APD334-308 |
| Percentage of Participants Achieving Sustained Clinical Remission | 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. | Week 40 of APD334-308 |
| Nagoya |
| Aichi-ken |
| 457-8511 |
| Japan |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| Toyohashi Municipal Hospital | Toyohashi | Aichi-ken | 441-8570 | Japan |
| Tsujinaka Hospital Kashiwanoha | Kashiwa-shi | Chiba | 277-0871 | Japan |
| Ishii Eye Clinic | Nagareyama-shi | Chiba | 270-0116 | Japan |
| Fukuoka University Hospital | Fukuoka | Fukuoka | 814-0180 | Japan |
| Takimoto Eye Clinic(OCT) | Kasuga-shi | Fukuoka | 816-0863 | Japan |
| Fakuoka Tokushukai Hospital | Kasuga-shi | Fukuoka | 816-0864 | Japan |
| Gifu University Hospital | Gifu | Gifu | 501-1194 | Japan |
| SUBARU Health Insurance Society Ota Memorial Hospital | Ota-shi | Gunma | 373-8585 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Asahikawa City Hospital | Asahikawa-shi | Hokkaido | 070-8610 | Japan |
| NHO Mito Medical Center | Higashiibaraki-gun | Ibaraki | 311-3193 | Japan |
| Matsumoto Eye Clinic | Toride-shi | Ibaraki | 302-0014 | Japan |
| NHO Kanazawa Medical Center | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Takamatsu Red Cross Hospital | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Kagawa Prefectural Central Hospital | Takamatsu | Kagawa-ken | 760-8557 | Japan |
| JA- Kagoshima Koseiren Hospital (PET/DLCO) | Kagoshima | Kagoshima-ken | 890-0062 | Japan |
| Kagoshima Kouseiren Hospital | Kagoshima | Kagoshima-ken | 890-0062 | Japan |
| Clinical Pathology Laboratory (Diagnostick center) | Kagoshima | Kagoshima-ken | 892-0813 | Japan |
| Jiaikai Idzuro Imamura Hospital | Kagoshima | Kagoshima-ken | 892-0824 | Japan |
| Sameshima Eye Clinic (OCT) | Kagoshima | Kagoshima-ken | 892-0825 | Japan |
| Sameshima Hospital | Kagoshima | Kagoshima-ken | 892-0846 | Japan |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | Kumamoto | 861-8520 | Japan |
| National Hospital Organization Kyoto Medical Center | Kyoto | Kyoto | 612-8555 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| Mie Prefectural General Medical Center | Yokkaichi-shi | Mie-ken | 510-8561 | Japan |
| JOHAS Tohoku Rokai Hospital | Sendai | Miyagi | 981-8563 | Japan |
| JOHAS Tohoku Rosai Hospital | Sendai | Miyagi | 981-8563 | Japan |
| Sendai City Hospital | Sendai | Miyagi | 982-8502 | Japan |
| Japan Community Health care Organization Osaka Hospital | Osaka | Osaka | 553-0003 | Japan |
| Saga University Hospital | Saga | Saga-ken | 849-8501 | Japan |
| St. Luke's International Hospital | Chuo-ku | Tokyo | 104-8560 | 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 |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Follow-up |
|
|
Full Analysis Set: All randomized participants who received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Comparator: Placebo | Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308 |
| BG001 | Experimental: Etrasimod 2 mg | Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308 |
| BG002 | 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 Achieving Clinical Remission at Week 40 of Study 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. | Full Analysis Set Population (All randomized participants who received at least 1 dose of study intervention). Only those participants with data available at the specified time points were analyzed. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". | Posted | Number | Percentage of participants | Week 40 of APD334-308 |
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| Secondary | Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study 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. | Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". | Posted | Number | Percentage of participants | Week 40 of APD334-308 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study 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. | Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 40 of APD334-308 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Mucosal Healing at Week 40 of Study 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. | Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 40 of APD334-308 |
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| Secondary | 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 | 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. | Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 40 of APD334-308 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Sustained Clinical Remission | 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. | Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 40 of APD334-308 |
|
All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308).
Safety set population included all randomized participants who received at least 1 dose of study intervention.
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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 Comparator: Placebo | Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308 | 0 | 14 | 1 | 14 | 8 | 14 |
| EG001 | Experimental: Etrasimod 2 mg | Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308 | 0 | 28 | 1 | 28 | 16 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
| ||
| Colitis ulcerative | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Malaise | General disorders | Non-systematic Assessment |
| ||
| Vaccination site pain | General disorders | Non-systematic Assessment |
| ||
| Infected dermal cyst | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Cervicobrachial syndrome | Nervous system disorders | Non-systematic Assessment |
| ||
| Cataract | Eye disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Glucose urine present | Investigations | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | 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 | Sep 26, 2022 | Sep 22, 2023 | SAP_002.pdf |
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| 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 |
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Not provided
| ID | Term |
|---|---|
| C000656249 | etrasimod |
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| Adverse Event |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Units | Counts |
|---|---|
| Participants |
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