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NCT Number: NCT05287126

A Study to Evaluate Etrasimod Treatment in Adolescents With 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).

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tsujinaka Hospital - Kashiwanoha, Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etrasimod

Drug

Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.

Other names: APD334

Primary outcomes

  1. Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52

    Time frame: Week 52

Secondary outcomes

  1. Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)

    Time frame: 4 hours (± 15 minutes) post-dose

  2. 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

  3. Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12

    Time frame: Week 12

  4. Proportion of Participants Achieving Endoscopic Improvement at Week 12

    Time frame: Week 12

  5. Proportion of Participants Achieving Endoscopic Improvement at Week 52

    Time frame: Week 52

  6. Proportion of Participants Achieving Symptomatic Remission at Week 12

    Time frame: Week 12

  7. Proportion of Participants Achieving Symptomatic Remission at Week 52

    Time frame: Week 52

  8. 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

  9. 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

  10. Proportion of Participants Achieving Clinical Response at Week 12

    Time frame: Week 12

  11. Proportion of Participants Achieving Clinical Response at Week 52

    Time frame: Week 52

  12. Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12

    Time frame: Week 12

  13. Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52

    Time frame: Week 52

  14. Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12

    Time frame: Week 12

  15. Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52

    Time frame: Week 52

  16. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Arena is a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2029
Study completion
2033
First posted
Mar 18, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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