A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

NCT ID: NCT05287126

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-16

Study Completion Date

2031-08-07

Brief Summary

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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).

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etrasimod

Group Type EXPERIMENTAL

Etrasimod

Intervention Type DRUG

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

Interventions

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Etrasimod

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

Intervention Type DRUG

Other Intervention Names

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APD334

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arena is a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Arkansas Children's (IP Address)

Little Rock, Arkansas, United States

Site Status NOT_YET_RECRUITING

Arkansas Children's

Little Rock, Arkansas, United States

Site Status NOT_YET_RECRUITING

Valley View Wellness Medical Center

Garden Grove, California, United States

Site Status RECRUITING

Loma Linda Children's Hospital

Loma Linda, California, United States

Site Status NOT_YET_RECRUITING

Loma Linda University Clinical Trial Center

Loma Linda, California, United States

Site Status NOT_YET_RECRUITING

Loma Linda University Eye Institute

Loma Linda, California, United States

Site Status NOT_YET_RECRUITING

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status NOT_YET_RECRUITING

Loma Linda University Pediatric Clinics

Loma Linda, California, United States

Site Status NOT_YET_RECRUITING

Loma Linda University Children's Hospital Pediatric Specialty Clinics

San Bernardino, California, United States

Site Status NOT_YET_RECRUITING

University of California San Francisco,

San Francisco, California, United States

Site Status RECRUITING

University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)

San Francisco, California, United States

Site Status RECRUITING

Arnold Palmer Hospital - Center for Digestive Health and Nutrition

Orlando, Florida, United States

Site Status RECRUITING

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status RECRUITING

University of Rochester Medical Center

Rochester, New York, United States

Site Status RECRUITING

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

Cleveland, Ohio, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Advance Clinical Trial PLLC

Abilene, Texas, United States

Site Status RECRUITING

Landeskrankenhaus Salzburg

Salzburg, , Austria

Site Status RECRUITING

University Hospitals Leuven

Leuven, , Belgium

Site Status RECRUITING

Tsujinaka Hospital - Kashiwanoha

Kashiwa, Chiba, Japan

Site Status RECRUITING

Ishii Eye Clinic

Nagareyama-shi, Chiba, Japan

Site Status RECRUITING

Gunma University Hospital

Maebashi, Gunma, Japan

Site Status NOT_YET_RECRUITING

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

Site Status RECRUITING

Kinki University - Nara Hospital

Ikoma, Nara, Japan

Site Status RECRUITING

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama, Japan

Site Status RECRUITING

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Site Status RECRUITING

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Site Status RECRUITING

Japanese Red Cross Kyoto Daini Hospital

Kyoto, , Japan

Site Status RECRUITING

Saga University Hospital

Saga, , Japan

Site Status RECRUITING

Toyama Prefectural Central Hospital

Toyama, , Japan

Site Status RECRUITING

Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Uniwersytecki Szpital Dziecięcy w Krakowie

Krakow, , Poland

Site Status RECRUITING

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Szczecin, , Poland

Site Status RECRUITING

Centrum Zdrowia MDM

Warsaw, , Poland

Site Status RECRUITING

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Site Status RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, , Poland

Site Status RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship, Poland

Site Status RECRUITING

Narodny ustav detskych chorob

Bratislava, Bratislava Region, Slovakia

Site Status NOT_YET_RECRUITING

Cliniq s.r.o.

Bratislava, , Slovakia

Site Status NOT_YET_RECRUITING

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna, Spain

Site Status NOT_YET_RECRUITING

Consorci Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Reina Sofia

Córdoba, , Spain

Site Status NOT_YET_RECRUITING

Countries

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United States Austria Belgium Japan Poland Slovakia Spain

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=APD334-207

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

Other Identifiers

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C5041010

Identifier Type: OTHER

Identifier Source: secondary_id

2022-500345-25-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

APD334-207

Identifier Type: -

Identifier Source: org_study_id

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