A Phase 2 interventional study of Etrasimod in Colitis, Ulcerative, sponsored by Pfizer. Recruiting at 46 sites in 10 countries. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
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).
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 24 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Etrasimod by mouth, once daily up to 52 weeks
Drug: Etrasimod
Once daily by mouth
Also known as: APD334
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.
Time frame: Week 52
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Weeks 2 and 4
Plan to share: Yes — 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.
Data sharing details ↗ · www.pfizer.com
Started May 2026 (actual). Primary completion is estimated for Sep 2030, 51 months after the start.
Of 109 industry-sponsored phase 2 interventional studies under Colitis, Ulcerative, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 35. This study's planned 51 months is above that.
Counting every sponsor, half of 153 studies reached it within 28 months; a quarter within 22 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Etrasimod