A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis (ELEVATE-UCkids)

August 21, 2026 updated by: Pfizer

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • The Children's Hospital at Westmead
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Not yet recruiting
        • Perth Children's Hospital
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Recruiting
        • Children's Hospital Research Institute of Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1S1
        • Recruiting
        • Health Sciences Centre Winnipeg
    • Quebec
      • Québec, Quebec, Canada, G1V4G2
        • Recruiting
        • CHU de Québec - Université Laval
  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades
    • Auvergne-Rhône-Alpes
      • Bron, Auvergne-Rhône-Alpes, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Hopital Femme Mere Enfant
  • Germany
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
      • Wuppertal, Germany, 42283
        • Recruiting
        • HELIOS Klinikum Wuppertal
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster - Albert Schweitzer Campus
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig
  • Israel
    • Central District
      • Ramat Gan, Central District, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
      • Rehovot, Central District, Israel, 7610001
        • Recruiting
        • Kaplan Medical Center
      • Rehovot, Central District, Israel, 7610001
        • Recruiting
        • Kaplan Medical Center Pharmacy
      • Ẕerifin, Central District, Israel, 70300
        • Recruiting
        • Yitzhak Shamir Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9013102
        • Recruiting
        • Shaare Zedek Medical Center
      • Jerusalem, Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
    • Northern District
      • Haifa, Northern District, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
      • Haifa, Northern District, Israel, 3436212
        • Recruiting
        • Carmel Medical Center
  • Italy
    • Lombardy
      • Bergamo, Lombardy, Italy, 24127
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Milan, Lombardy, Italy, 20122
        • Not yet recruiting
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
    • Tuscany
      • Florence, Tuscany, Italy, 50139
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Meyer IRCCS
  • Japan
      • Kumamoto, Japan, 861-8520
        • Recruiting
        • Japanese Red Cross Kumamoto Hospital
      • Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
    • Saitama
      • Saitama-shi, Saitama, Japan, 330-8777
        • Recruiting
        • Saitama Prefectural Children's Medical Center
  • Poland
      • Katowice, Poland, 40-600
        • Recruiting
        • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
      • Warsaw, Poland, 04-730
        • Recruiting
        • Instytut "Pomnik - Centrum Zdrowia Dziecka"
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 04-501
        • Recruiting
        • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
      • Warsaw, Masovian Voivodeship, Poland, 00-189
        • Recruiting
        • Centrum Zdrowia MDM
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Not yet recruiting
        • Bristol Royal Hospital for Children
      • Liverpool, United Kingdom, L14 5AB
        • Recruiting
        • Alder Hey Children's Hospital
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Evelina London Children's Hospital
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital
    • London, CITY of
      • London, London, CITY of, United Kingdom, SE5 9RL
        • Recruiting
        • King's College Hospital
  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Grossman School of Medicine
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Inflammatory Bowel Disease Center
      • New York, New York, United States, 10016
        • Recruiting
        • Fink Children's Ambulatory Care Center
      • New York, New York, United States, 10016
        • Recruiting
        • Kimmel Pavilion - NYU Langone
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health (Tisch Hospital)
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Radiology - Tisch Hospital
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Medical Science Building (MSB)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Etrasimod
Etrasimod by mouth, once daily up to 52 weeks
Drug: Etrasimod
Once daily by mouth
Other Names:
  • APD334

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Week 12
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.
Week 12
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.
Week 52
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.
Week 12
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.
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
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.
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
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.
Week 52
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.
Week 52
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.
Baseline, through Week 260
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.
Baseline, through Week 260
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
Week 2
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
Week 12
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.
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.
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.
Baseline up to 28 days after last dose of study intervention
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.
Baseline up to 28 days after last dose of study intervention
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.
Baseline up to week 260
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.
Baseline, Weeks 2 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C5041018
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • APD334-208 (Other Identifier: Alias Study Number)
  • 2025-523100-77-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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