A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

May 1, 2024 updated by: Pfizer

An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects 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), or until marketing authorization is obtained in the participant's country, whichever comes first.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2

Expanded Access

Available 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 Locations

  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Landeskrankenhaus Salzburg
  • Belgium
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • University Hospitals Leuven
  • 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
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital
    • Nara
      • Ikoma City, 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
        • Not yet recruiting
        • Juntendo University Hospital
  • Poland
      • Krakow, Poland, 30-663
        • Recruiting
        • Uniwersytecki Szpital Dzieciecy w Krakowie
      • Szczecin, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Warsaw, Poland, 00-635
        • Recruiting
        • Centrum Zdrowia MDM
      • Warsaw, Poland, 00-728
        • Recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warszawa, Poland, 00-189
        • Recruiting
        • Centrum Zdrowia MDM
      • Wroclaw, Poland, 50-369
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 04-730
        • Recruiting
        • Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
    • Łódzkie
      • Lodz, Łódzkie, Poland, 93-338
        • Recruiting
        • Instytut Centrum Zdrowia Matki Polki
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
      • Cordoba, Spain, 14004
        • Not yet recruiting
        • Hospital Reina Sofía
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Not yet recruiting
        • Hospital Clinico Universitario de Santiago de Compostela
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Consorci Corporacio Sanitaria Parc Tauli
  • 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
      • Orange, California, United States, 92868
        • Recruiting
        • Childrens Hospital of Orange County
      • 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
      • Kissimmee, Florida, United States, 34741
        • Recruiting
        • IHS Health Research
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Nemours Children's Hospital
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Arnold Palmer Hospital - Center for Digestive Health and Nutrition
      • Windermere, Florida, United States, 34741
        • Recruiting
        • Kissimmee Endoscopy Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Children's Center for Digestive Health Care, LLC
    • 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 Hospital
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Beaumont Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center Clinical Research Center
    • 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
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Recruiting
        • GI for Kids
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Tennessee Eye Care
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • East Tennessee Children's Hospital
      • Knoxville, Tennessee, United States, 37919
        • Recruiting
        • Statcare Pulmonary
      • Knoxville, Tennessee, United States, 37934
        • Recruiting
        • Tennova
    • Texas
      • Abilene, Texas, United States, 79606
        • Not yet recruiting
        • DCT - Midwest GI
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Advance Clinical Trial PLLC

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

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
Intervention / Treatment
Experimental: Etrasimod
Drug: Etrasimod
Etrasimod tablet by mouth, once daily up to 52 weeks of treatment.
Other Names:
  • APD334

What is the study measuring?

Primary Outcome Measures

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

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

Pfizer

Collaborators

Arena is a wholly owned subsidiary of Pfizer

Investigators

  • 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)

December 16, 2022

Primary Completion (Estimated)

July 14, 2027

Study Completion (Estimated)

August 7, 2031

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Estimated)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APD334-207
  • 2021-003627-15 (EudraCT Number)
  • 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.

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