Colitis, Ulcerative
Etrasimod study in children with moderately to severely active ulcerative colitis
This study is examining the safety, effects, and pharmacokinetics of once-daily oral etrasimod in children ages 2–11 with moderately to severely active ulcerative colitis.
Registry title: A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
7 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–11 Years
- Treatment
- Etrasimod
- Design
- Not provided
- Central study contact
- Pfizer CT.gov Call Center1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com
- Sponsor
- Pfizer
Research question
What are the safety, treatment effects, and pharmacokinetics—how etrasimod moves through the body—of etrasimod in children with moderately to severely active ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for children ages 2 through 11.
- The study is looking for children diagnosed with ulcerative colitis.
- The ulcerative colitis must be moderately to severely active.
- Children of any sex may be considered, but the study team must confirm all criteria.
- The registry permits selected ulcerative colitis therapies at a therapeutic dose, although it does not identify them.
Participation overview
What participation may involve
Participants take etrasimod by mouth once daily for up to 52 weeks. Those completing that period may have the opportunity to enter a long-term extension lasting up to four additional years. What participation may involve: - Take etrasimod by mouth once daily. - Complete ulcerative colitis assessments based on the Modified Mayo Score and Pediatric Ulcerative Colitis Activity Index. - Undergo safety monitoring that includes adverse-event review, laboratory examinations, and vital-sign measurements. - Provide blood samples before dosing at baseline and Weeks 2 and 4 so researchers can measure etrasimod concentrations. - Complete taste-acceptability questionnaires about etrasimod tablets and granules at Weeks 2 and 12. The initial treatment period lasts up to 52 weeks. Participants who complete it may be offered a long-term extension of up to four years, for up to five years after enrollment.
Study interventions
What participants may receive or do
- Etrasimod: Participants receive etrasimod by mouth once daily. The study arm states that treatment continues for up to 52 weeks.
Study design
How the comparison works
This is an open-label Phase 2 study with one experimental group. All enrolled participants are assigned to the etrasimod arm. The registry reports allocation as not applicable because this is a single-group study. There is no masking: participants and study staff know that etrasimod is being given. The registry lists only one experimental etrasimod arm and no separate comparison group. No placebo intervention or placebo arm is listed in the registry record.
Reported activities
Procedures and tests
- Modified Mayo Score assessments evaluate ulcerative colitis activity, including stool frequency, rectal bleeding, and endoscopic findings.
- Endoscopic improvement is assessed at Weeks 12 and 52.
- The Pediatric Ulcerative Colitis Activity Index is assessed at each visit through Week 260.
- Taste-acceptability questionnaires about etrasimod tablets and granules are completed at Weeks 2 and 12.
- Height and weight are measured at each visit through Week 260.
- Adverse events, including serious events and events leading to treatment discontinuation, are monitored through 28 days after the last dose.
- Laboratory monitoring includes blood counts, liver and kidney measures, electrolytes, glucose, and urinalysis.
- Vital-sign monitoring includes blood pressure, breathing rate, pulse, temperature, and body weight.
- Blood samples collected before daily dosing at baseline and Weeks 2 and 4 are used to measure etrasimod concentrations.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 2 through 11 years old.
- Participants must have ulcerative colitis that is moderately to severely active.
- Selected ulcerative colitis therapies are permitted at a therapeutic dose, but the registry does not name them.
Possible reasons someone may not be able to join
- Children with severe extensive colitis are excluded.
- Children diagnosed with Crohn's disease or indeterminate colitis are excluded.
- A current or past fistula consistent with Crohn's disease is exclusionary.
- Children diagnosed with microscopic, ischemic, or infectious colitis are excluded.
Important unknowns
What the record does not make clear
- The record names several assessment weeks but does not provide a complete visit schedule or say which visits are in person.
- The registry says selected ulcerative colitis therapies may continue at therapeutic doses but does not name the permitted therapies or dosing rules.
- The record does not state whether any medicines must be stopped or how long any washout period would last.
- The record does not describe what treatment is available if ulcerative colitis worsens during the study.
- Endoscopic outcomes are listed for Weeks 12 and 52, but the record does not give the complete procedure schedule, preparation, sedation, or biopsy requirements.
- The record does not state which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants or families receive compensation or expense reimbursement.
- The record lists study locations but does not describe travel, lodging, parking, or meal support.
- The record does not say whether any visits or assessments can be completed remotely or near the participant's home.
- A long-term extension and a separate expanded-access record are mentioned, but continued access requirements and availability for an individual participant are not explained.
Before contacting the site
Questions for the study team
- What is the full visit schedule, and which visits require travel to the study center?
- Which ulcerative colitis medicines may continue, and which must be changed or stopped before the study?
- What endoscopies are required at screening and during the study, and will they involve sedation or biopsies?
- What happens if the child's ulcerative colitis worsens while taking etrasimod?
- Which study-related costs are covered, and are travel expenses or caregiver time reimbursed?
- What requirements must a participant meet to enter the long-term extension after Week 52?
- Which formulation would the child receive—tablet, granules, or another form—and how is the dose selected?
Before changing care
Questions for your gastroenterologist
- How stable is my child's ulcerative colitis now, and what would worsening look like during this study?
- Could joining this study require changes to my child's current medicines, and what risks could those changes create?
- What approved treatment alternatives should we compare with this study for my child's current disease activity?
- How do the study's laboratory, vital-sign, blood-sampling, and endoscopy assessments fit my child's medical needs and risks?
- How should you and the research team coordinate care if symptoms worsen or an adverse event occurs?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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).
Study design and administration
- Organization
- Pfizer
- Organization class
- Industry
- Organization study ID
- C5041018
- Lead sponsor
- Pfizer
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child
Study arms
Experimental
Etrasimod
Etrasimod by mouth, once daily up to 52 weeks
Interventions: Drug: Etrasimod
Interventions
Drug
Etrasimod
Once daily by mouth
Eligibility
2 Years–11 Years
All
Not accepted
Inclusion criteria (1)
- 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 therapiesRegistry-derived · unreviewed
Exclusion criteria (1)
- 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 colitisRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Secondary outcome
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.
Recruiting locations in the United States
Fink Children's Ambulatory Care Center
RecruitingNew York, New York, 10016, United States
Kimmel Pavilion - NYU Langone
RecruitingNew York, New York, 10016, United States
NYU Grossman School of Medicine
RecruitingNew York, New York, 10016, United States
NYU Langone Health (Tisch Hospital)
RecruitingNew York, New York, 10016, United States
NYU Langone Inflammatory Bowel Disease Center
RecruitingNew York, New York, 10016, United States
NYU Langone Radiology - Tisch Hospital
RecruitingNew York, New York, 10016, United States
NYU Medical Science Building (MSB)
RecruitingNew York, New York, 10016, United States
This study also lists 35 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Mar 13, 2026
- Primary completion
- Sep 8, 2030
- Overall completion
- Aug 18, 2034
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.