A Phase 2 Open-Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis)
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis (ELEVATE-UC kids)
Kawai Norisuke
Pfizer R&D Japan G.K.
Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo
+81-3-5309-7000
clinical-trials@pfizer.com
Clinical Trials Information Desk
Pfizer R&D Japan G.K.
Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo
+81-3-5309-7000
clinical-trials@pfizer.com
Recruiting
Feb. 27, 2026
24
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
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
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
2age old over
12age old not
Both
Colitis, Ulcerative
Drug: Etrasimod
Once daily by mouth
Other Names:
APD334
Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 [Time Frame: 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.
*Number and percent of enrolled participants with clinical remission based on MMS at Week 12 [Time Frame: 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.
*Number and percent of enrolled participants with clinical response based on MMS score components at Week 12 [Time Frame: 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.
*Number and percent of enrolled participants with clinical response based on MMS score components at Week 52 [Time Frame: 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.
*Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 12 [Time Frame: 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.
*Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 52 [Time Frame: 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.
*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 [Time Frame: 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.
*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 [Time Frame: 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.
*Number and percent of enrolled participants Symptomatic remission at all time points up to Week 52 [Time Frame: 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.
*Number and percent of enrolled participants Pediatric Ulcerative Colitis Activity Index (PUCAI) clinical remission from baseline to Week 260 [Time Frame: Baseline, through 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.
*Number and percent of enrolled participants PUCAI clinical response from baseline to Week 260 [Time Frame: Baseline, through 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.
*Number and percentage of participants reporting a positive taste/palatability score [Time Frame: Week 2]
-The responses to taste acceptability questionnaire on etrasimod tablets and granules will be summarized using count and percentage for SAS
*Number and percentage of participants reporting a positive taste/palatability score [Time Frame: Week 12]
-The responses to taste acceptability questionnaire on etrasimod tablets and granules will be summarized using count and percentage for SAS
*Change from baseline in Z-Scores height and weight [Time Frame: Baseline through Week 260]
-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.
*Number of Participants with Treatment Emergent Treatment-Related Adverse Events (AEs), including Serious Adverse Events (SAEs) and AEs leading to discontinuation. [Time Frame: Baseline up to 28 days after last dose of study intervention]
-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.
*Number of Participants with Clinically Significant Findings in Laboratory Examinations [Time Frame: Baseline up to 28 days after last dose of study intervention]
-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.
*Number of Participants with Clinically Significant Change in Vital Signs [Time Frame: Baseline up to week 260]
*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.
*Plasma concentration verses time of study intervention [Time Frame: Baseline, Weeks 2 and 4]
-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.
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.
