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NCT05287126PHASE2Recruiting

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Pfizer

Start Date

12/16/2022

Completion Date

7/10/2033

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 Criteria

Age Range: 12 years to 17 years

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

Interventions

DRUG

Etrasimod

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Conditions

Ulcerative Colitis

Locations

Arkansas Children's (IP Address)

Little Rock, Arkansas 72202

United States

Arkansas Children's

Little Rock, Arkansas 72202

United States

Valley View Wellness Medical Center

Garden Grove, California 92845

United States

Loma Linda Children's Hospital

Loma Linda, California 92354

United States

Loma Linda University Clinical Trial Center

Loma Linda, California 92354

United States

Loma Linda University Eye Institute

Loma Linda, California 92354

United States

Loma Linda University Medical Center

Loma Linda, California 92354

United States

Loma Linda University Pediatric Clinics

Loma Linda, California 92354

United States

Loma Linda University Children's Hospital Pediatric Specialty Clinics

San Bernardino, California 92408

United States

University of California San Francisco,

San Francisco, California 94158

United States

University of California San Francisco

San Francisco, California 94158

United States

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

San Francisco, California 94158

United States

Arnold Palmer Hospital - Center for Digestive Health and Nutrition

Orlando, Florida 32806

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

William Beaumont Hospital/Corewell Health - East

Royal Oak, Michigan 48073

United States

William Beaumont Hospitals Reference Laboratory

Royal Oak, Michigan 48073

United States

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

Cleveland, Ohio 44106

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

ACT-Midwest G1

Abilene, Texas 79606

United States

Tsujinaka Hospital - Kashiwanoha

Kashiwa, Chiba 277-0871

Japan

Ishii Eye Clinic

Nagareyama-shi, Chiba 270-0116

Japan

Gunma University Hospital

Maebashi, Gunma 371-8511

Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo 663-8501

Japan

Kinki University - Nara Hospital

Ikoma, Nara 630-0293

Japan

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama 330-8777

Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi 329 0498

Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo 113-8431

Japan

Japanese Red Cross Kyoto Daini Hospital

Kyoto, 602-8026

Japan

Saga University Hospital

Saga, 849-8501

Japan

Toyama Prefectural Central Hospital

Toyama, 930-8550

Japan

WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Masovian Voivodeship 04-501

Poland

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

Warsaw, Masovian Voivodeship 04-730

Poland

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

Katowice, 40-600

Poland

Uniwersytecki Szpital Dziecięcy w Krakowie

Krakow, 30-663

Poland

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Szczecin, 71-434

Poland

Centrum Zdrowia MDM

Warsaw, 00-189

Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728

Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, 50-369

Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship 93-338

Poland

K.M. Management, spol. s r.o.

Nitra, 949 01

Slovakia

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna 15706

Spain

Consorci Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona 08208

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Reina Sofia

Córdoba, 14004

Spain