RecruitingPhase 2NCT05287126

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


Sponsor

Pfizer

Enrollment

36 participants

Start Date

Dec 16, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests etrasimod — an oral pill that dampens an overactive immune response — in teenagers with moderately to severely active ulcerative colitis (UC), an inflammatory bowel disease that causes chronic colon inflammation, pain, and diarrhea. The goal is to determine whether etrasimod is safe and effective in younger patients. **You may be eligible if...** - You are an adolescent with a confirmed diagnosis of moderately to severely active ulcerative colitis - You may be on certain standard UC medications while enrolling **You may NOT be eligible if...** - You have severe extensive colitis - You have been diagnosed with Crohn's disease, microscopic colitis, ischemic colitis, or infectious colitis - You have a fistula consistent with Crohn's disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtrasimod

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


Locations(47)

Arkansas Children's (IP Address)

Little Rock, Arkansas, United States

Arkansas Children's

Little Rock, Arkansas, United States

Valley View Wellness Medical Center

Garden Grove, California, United States

Loma Linda Children's Hospital

Loma Linda, California, United States

Loma Linda University Clinical Trial Center

Loma Linda, California, United States

Loma Linda University Eye Institute

Loma Linda, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Loma Linda University Pediatric Clinics

Loma Linda, California, United States

Loma Linda University Children's Hospital Pediatric Specialty Clinics

San Bernardino, California, United States

University of California San Francisco,

San Francisco, California, United States

University of California San Francisco

San Francisco, California, United States

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

San Francisco, California, United States

Arnold Palmer Hospital - Center for Digestive Health and Nutrition

Orlando, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

William Beaumont Hospital/Corewell Health - East

Royal Oak, Michigan, United States

William Beaumont Hospitals Reference Laboratory

Royal Oak, Michigan, United States

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

Cleveland, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

ACT-Midwest G1

Abilene, Texas, United States

Landeskrankenhaus Salzburg

Salzburg, Austria

University Hospitals Leuven

Leuven, Belgium

Tsujinaka Hospital - Kashiwanoha

Kashiwa, Chiba, Japan

Ishii Eye Clinic

Nagareyama-shi, Chiba, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

Kinki University - Nara Hospital

Ikoma, Nara, Japan

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan

Saga University Hospital

Saga, Japan

Toyama Prefectural Central Hospital

Toyama, Japan

WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Masovian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Uniwersytecki Szpital Dziecięcy w Krakowie

Krakow, Poland

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Szczecin, Poland

Centrum Zdrowia MDM

Warsaw, Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship, Poland

Narodny ustav detskych chorob

Bratislava, Bratislava Region, Slovakia

Cliniq s.r.o.

Bratislava, Slovakia

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna, Spain

Consorci Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Reina Sofia

Córdoba, Spain

View Full Details on ClinicalTrials.gov

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NCT05287126


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