A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

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: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Etrasimod

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • 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
  • 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 Kierkuś
  • 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 Kierkuś
    • 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 Sofia
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • 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
    • 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

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)		4 hours (± 15 minutes) post-dose
Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod		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		Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 12		Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 52		Week 52
Proportion of Participants Achieving Symptomatic Remission at Week 12		Week 12
Proportion of Participants Achieving Symptomatic Remission at 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		Week 12
Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52		Week 52
Proportion of Participants Achieving Clinical Response at Week 12		Week 12
Proportion of Participants Achieving Clinical Response at Week 52		Week 52
Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12		Week 12
Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52		Week 52
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12		Week 12
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52		Week 52
Number and Severity of Adverse Events	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

• Sponsor: Pfizer
• Collaborators: Arena is a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Estimated): June 16, 2029
• Study Completion (Estimated): July 10, 2033

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 (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Pharmacokinetics; APD334; Active Ulcerative Colitis
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; etrasimod
• Other Study ID 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