A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

NCT05287126 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: APD334-207C50410102022-500345-25-00
• Study Type: interventional
• Target: 36
• Locations: 6 countries
• Sites: 24

Brief Summary

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).

Conditions

Ulcerative Colitis

Keywords

Pharmacokinetics; Adolescents; Active Ulcerative Colitis; APD334

Outcome Measures

Primary Outcomes (1)

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

  Week 52

Secondary Outcomes (16)

• 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

Study Arms (1)

Etrasimod

EXPERIMENTAL

Drug: Etrasimod

Interventions

Etrasimod DRUG

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

Also known as: APD334

Etrasimod

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• Arena is a wholly owned subsidiary of Pfizer: collaborator

Study Sites (24)

Arkansas Children's (IP Address)

Little Rock, Arkansas, 72202, United States

NOT YET RECRUITING

Loma Linda University Eye Institute

Loma Linda, California, 92354, United States

NOT YET RECRUITING

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

NOT YET RECRUITING

Loma Linda University Pediatric Clinics

Loma Linda, California, 92354, United States

NOT YET RECRUITING

Loma Linda University Children's Hospital Pediatric Specialty Clinics

San Bernardino, California, 92408, United States

NOT YET RECRUITING

Arnold Palmer Hospital - Center for Digestive Health and Nutrition

Orlando, Florida, 32806, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

William Beaumont Hospitals Reference Laboratory

Royal Oak, Michigan, 48073, United States

RECRUITING

University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Landeskrankenhaus Salzburg

Salzburg, 5020, Austria

RECRUITING

Gunma University Hospital

Maebashi, Gunma, 371-8511, Japan

RECRUITING

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

RECRUITING

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Japanese Red Cross Kyoto Daini Hospital

Kyoto, 602-8026, Japan

RECRUITING

Saga University Hospital

Saga, 849-8501, Japan

RECRUITING

WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Masovian Voivodeship, 04-501, Poland

RECRUITING

Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

Katowice, 40-600, Poland

NOT YET RECRUITING

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728, Poland

RECRUITING

Narodny ustav detskych chorob

Bratislava, Bratislava Region, 833 40, Slovakia

NOT YET RECRUITING

Cliniq s.r.o.

Bratislava, 811 09, Slovakia

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Reina Sofia

Córdoba, 14004, Spain

NOT YET RECRUITING

Related Links

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

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

etrasimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: December 16, 2022
• Primary Completion (Estimated): June 16, 2029
• Study Completion (Estimated): July 10, 2033
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); US (11); PL (3); ES (2); SL (2); JP (5)