A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

July 7, 2026 updated by: Pfizer

An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent 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 adolescents (≥ 12 years up to < 18 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.
36

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

  • Japan
      • Kyoto, Japan, 602-8026
        • Recruiting
        • Japanese Red Cross Kyoto Daini Hospital
      • Saga, Japan, 849-8501
        • Recruiting
        • Saga University Hospital
      • Toyama, Japan, 930-8550
        • Recruiting
        • Toyama Prefectural Central Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital - Kashiwanoha
      • Nagareyama-shi, Chiba, Japan, 270-0116
        • Recruiting
        • Ishii Eye Clinic
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Recruiting
        • Gunma University Hospital
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital
    • Nara
      • Ikoma, Nara, Japan, 630-0293
        • Recruiting
        • Kinki University - Nara Hospital
    • Saitama
      • Saitama-shi, Saitama, Japan, 330-8777
        • Recruiting
        • Saitama Prefectural Children's Medical Center
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329 0498
        • Recruiting
        • Jichi Medical University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
  • Poland
      • Katowice, Poland, 40-600
        • Not yet recruiting
        • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
      • Krakow, Poland, 30-663
        • Recruiting
        • Uniwersytecki Szpital Dzieciecy w Krakowie
      • Szczecin, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Warsaw, Poland, 00-728
        • Recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warsaw, Poland, 00-189
        • Recruiting
        • Centrum Zdrowia MDM
      • Wroclaw, Poland, 50-369
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 04-501
        • Recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warsaw, Masovian Voivodeship, Poland, 04-730
        • Recruiting
        • Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-338
        • Active, not recruiting
        • Instytut Centrum Zdrowia Matki Polki
  • Slovakia
      • Nitra, Slovakia, 949 01
        • Recruiting
        • K.M. Management, spol. s r.o.
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Reina Sofía
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario de Santiago de Compostela
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Consorci Corporació Sanitària Parc Taulí
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Not yet recruiting
        • Arkansas Children's (IP Address)
      • Little Rock, Arkansas, United States, 72202
        • Not yet recruiting
        • Arkansas Children's
    • California
      • Garden Grove, California, United States, 92845
        • Recruiting
        • Valley View Wellness Medical Center
      • Loma Linda, California, United States, 92354
        • Not yet recruiting
        • Loma Linda University Medical Center
      • Loma Linda, California, United States, 92354
        • Not yet recruiting
        • Loma Linda University Eye Institute
      • Loma Linda, California, United States, 92354
        • Not yet recruiting
        • Loma Linda Children's Hospital
      • Loma Linda, California, United States, 92354
        • Not yet recruiting
        • Loma Linda University Clinical Trial Center
      • Loma Linda, California, United States, 92354
        • Not yet recruiting
        • Loma Linda University Pediatric Clinics
      • San Bernardino, California, United States, 92408
        • Not yet recruiting
        • Loma Linda University Children's Hospital Pediatric Specialty Clinics
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco,
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Arnold Palmer Hospital - Center for Digestive Health and Nutrition
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University Of Chicago Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • William Beaumont Hospitals Reference Laboratory
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • William Beaumont Hospital/Corewell Health - East
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • ACT-Midwest G1

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

12 years to 17 years (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
Drug: Etrasimod
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
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
Time Frame
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
Time Frame: Week 52
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
Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)
Time Frame: 4 hours (± 15 minutes) post-dose
4 hours (± 15 minutes) post-dose
Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod
Time Frame: pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12
Time Frame: Week 12
Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 12
Time Frame: Week 12
Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 52
Time Frame: Week 52
Week 52
Proportion of Participants Achieving Symptomatic Remission at Week 12
Time Frame: Week 12
Week 12
Proportion of Participants Achieving Symptomatic Remission at Week 52
Time Frame: Week 52
Week 52
Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12
Time Frame: Week 12
Week 12
Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52
Time Frame: Week 52
Week 52
Proportion of Participants Achieving Clinical Response at Week 12
Time Frame: Week 12
Week 12
Proportion of Participants Achieving Clinical Response at Week 52
Time Frame: Week 52
Week 52
Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12
Time Frame: Week 12
Week 12
Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52
Time Frame: Week 52
Week 52
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12
Time Frame: Week 12
Week 12
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52
Time Frame: Week 52
Week 52
Number and Severity of Adverse Events
Time Frame: Up to Week 52
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Up to Week 52

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Arena is a wholly owned subsidiary of 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.
December 16, 2022

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.
June 16, 2029

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.
July 10, 2033

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, 2022

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, 2022

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 18, 2022

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.
July 8, 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.
July 7, 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.
July 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.
  • APD334-207
  • C5041010 (Other Identifier: Alias Study Number)
  • 2022-500345-25-00 (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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings