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| ID | Type | Description | Link |
|---|---|---|---|
| APD334-208 | Other Identifier | Alias Study Number | |
| 2025-523100-77-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to < 12 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etrasimod | Experimental | Etrasimod by mouth, once daily up to 52 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod | Drug | Once daily by mouth |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 | Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percent of enrolled participants with clinical remission based on MMS at Week 12 | Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. |
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Inclusion criteria:
Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active Participants are permitted to be receiving a therapeutic dose of select UC therapies
Exclusion criteria:
Severe extensive colitis Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre Winnipeg | Not yet recruiting | Winnipeg | Manitoba | R3A 1S1 | Canada | |
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| 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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| Week 12 |
| Number and percent of enrolled participants with clinical response based on MMS score components at Week 12 | Clinical response was defined as a ≥2-point and ≥30% decrease from baseline in MMS, and a ≥1-point decrease from baseline in RB subscore or an absolute RB subscore ≤ 1. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Week 12 |
| Number and percent of enrolled participants with clinical response based on MMS score components at Week 52 | Clinical response was defined as a ≥2-point and ≥30% decrease from baseline in MMS, and a ≥1-point decrease from baseline in RB subscore or an absolute RB subscore ≤ 1. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Week 52 |
| Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 12 | Endoscopic improvement defined as ES ≤1 (excluding friability). These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Week 12 |
| Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 52 | Endoscopic improvement defined as ES ≤1 (excluding friability). These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Week 52 |
| Number and percent of enrolled participants Clinical remission at Week 12 and who had not been receiving corticosteroids for ≥2 weeks immediately prior to Week 12 | Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Number of weeks off corticosteroids prior to week 12 visit will be used to determine end point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Week 12 |
| Number and percent of enrolled participants Clinical remission at Week 52 and who had not been receiving corticosteroids for ≥12 weeks immediately prior to Week 52 | Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Number of weeks off corticosteroids prior to week 52 visit will be used to determine end point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Week 52 |
| Number and percent of enrolled participants Symptomatic remission at all time points up to Week 52 | Symptomatic remission was defined as SF subscore = 0 or 1 and an RB subscore = 0. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Week 52 |
| Number and percent of enrolled participants Pediatric Ulcerative Colitis Activity Index (PUCAI) clinical remission from baseline to Week 260 | Clinical remission by PUCAI is defined as a score <10. These assessments will be conducted at each visit. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Baseline, through Week 260 |
| Number and percent of enrolled participants PUCAI clinical response from baseline to Week 260 | Clinical response by PUCAI is defined as a score ≥ 20 point reduction from baseline. These assessments will be conducted at each visit.These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. | Baseline, through Week 260 |
| Number and percentage of participants reporting a positive taste/palatability score | The responses to taste acceptability questionnaire on etrasimod tablets and granules will be summarized using count and percentage for SAS | Week 2 |
| Number and percentage of participants reporting a positive taste/palatability score | The responses to taste acceptability questionnaire on etrasimod tablets and granules will be summarized using count and percentage for SAS | Week 12 |
| Change from baseline in Z-Scores height and weight | These assessments will be conducted at each visit. The values and change from baseline will be summarized using number of observations, mean, standard deviation, minimum and maximum values by visit for SAS. | Baseline through Week 260 |
| Number of Participants with Treatment Emergent Treatment-Related Adverse Events (AEs), including Serious Adverse Events (SAEs) and AEs leading to discontinuation. | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to etrasimod was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Baseline up to 28 days after last dose of study intervention |
| Number of Participants with Clinically Significant Findings in Laboratory Examinations | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Hepatobiliary biochemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin ; Renal Function Tests: Blood Urea Nitrogen (BUN), Creatinine, Creatinine Kinase, Uric Acid ; Electrolytes: Sodium, Potassium; Glucose; Urine analysis: (decimal logarithm of reciprocal of hydrogen ion activity )[pH], Specific gravity. Clinically significant laboratory abnormality findings were based on investigator discretion. | Baseline up to 28 days after last dose of study intervention |
| Number of Participants with Clinically Significant Change in Vital Signs | Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and body weight. Number of participants with clinically significant change in any vital sign parameter compared to baseline were reported. Clinically significant change in vital signs criteria were based on investigator's discretion. | Baseline up to week 260 |
| Plasma concentration verses time of study intervention | Samples collected prior to daily dosing of study intervention for measurement of plasma concentrations of etrasimod will be analyzed using a validated analytical method in compliance with applicable SOPs. | Baseline, Weeks 2 and 4 |
| Children's Hospital Research Institute of Manitoba |
| Not yet recruiting |
| Winnipeg |
| Manitoba |
| R3E 3P4 |
| Canada |
| CHU de Québec - Université Laval | Recruiting | Québec | Quebec | G1V4G2 | Canada |
| Hospices Civils de Lyon - Hôpital Femme Mère Enfant | Recruiting | Bron | Auvergne-Rhône-Alpes | 69500 | France |
| Hôpital Universitaire Necker Enfants Malades | Not yet recruiting | Paris | 75015 | France |
| Universitätsklinikum Münster - Albert Schweitzer Campus | Not yet recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitätsklinikum Leipzig | Not yet recruiting | Leipzig | Saxony | 04103 | Germany |
| Universitaetsklinikum Tuebingen | Recruiting | Tübingen | 72076 | Germany |
| HELIOS Klinikum Wuppertal | Recruiting | Wuppertal | 42283 | Germany |
| Sheba Medical Center | Not yet recruiting | Ramat Gan | Central District | 5262100 | Israel |
| Yitzhak Shamir Medical Center | Not yet recruiting | Ẕerifin | Central District | 70300 | Israel |
| Shaare Zedek Medical Center | Recruiting | Jerusalem | Jerusalem | 9013102 | Israel |
| Hadassah Medical Center | Recruiting | Jerusalem | Jerusalem | 9112001 | Israel |
| Rambam Health Care Campus | Not yet recruiting | Haifa | Northern District | 3109601 | Israel |
| Azienda Ospedaliera Universitaria Meyer IRCCS | Not yet recruiting | Florence | Tuscany | 50139 | Italy |
| Saitama Prefectural Children's Medical Center | Recruiting | Saitama-shi | Saitama | 330-8777 | Japan |
| Japanese Red Cross Kumamoto Hospital | Recruiting | Kumamoto | 861-8520 | Japan |
| Juntendo University Hospital | Recruiting | Tokyo | 113-8431 | Japan |
| Centrum Zdrowia MDM | Recruiting | Warsaw | Masovian Voivodeship | 00-189 | Poland |
| Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś | Recruiting | Warsaw | Masovian Voivodeship | 04-501 | Poland |
| Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero | Recruiting | Katowice | 40-600 | Poland |
| Instytut "Pomnik - Centrum Zdrowia Dziecka" | Recruiting | Warsaw | 04-730 | Poland |
| King's College Hospital | Not yet recruiting | London | London, CITY of | SE5 9RL | United Kingdom |
| Evelina London Children's Hospital | Recruiting | London | SE1 7EH | United Kingdom |
| Sheffield Children's Hospital | Recruiting | Sheffield | S10 2TH | United Kingdom |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D014456 | Ulcer |
| D003092 | Colitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000656249 | etrasimod |
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