A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Phase

Condition

Colic

Inflammatory Bowel Disease

Ulcers

Treatment

Etrasimod

Clinical Study ID

NCT05287126

APD334-207

2022-500345-25-00

2021-003627-15

C5041010

Ages 12-17
All Genders

Study 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

Inclusion

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

Exclusion criteria:

Severe extensive colitis
Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence orhistory of a fistula consistent with CD
Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Study Design

Etrasimod

December 16, 2022

July 10, 2033

Connect with a study center

Landeskrankenhaus Salzburg
Salzburg, 5020
Austria
Active - Recruiting
Landeskrankenhaus Salzburg
Salzburg 2766824, 5020
Austria
Site Not Available
UZ Leuven
Leuven, 3000
Belgium
Site Not Available
University Hospitals Leuven
Leuven, 3000
Belgium
Active - Recruiting
University Hospitals Leuven
Leuven 2792482, 3000
Belgium
Site Not Available
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Chiba 277-0871
Japan
Site Not Available
Tsujinaka Hospital - Kashiwanoha
Kashiwa 1859924, Chiba 2113014 277-0871
Japan
Site Not Available
Ishii Eye Clinic
Nagareyama-shi, Chiba 2113014 270-0116
Japan
Site Not Available
Gunma University Hospital
Maebashi, Gunma 371-8511
Japan
Active - Recruiting
Gunma University Hospital
Maebashi 1857843, Gunma 1863501 371-8511
Japan
Site Not Available
Hyogo Medical University Hospital
Nishinomiya, Hyōgo 663-8501
Japan
Active - Recruiting
Hyogo Medical University Hospital
Nishinomiya 1855207, Hyōgo 1862047 663-8501
Japan
Site Not Available
Kinki University - Nara Hospital
Ikoma, Nara 630-0293
Japan
Site Not Available
Kinki University - Nara Hospital
Ikoma City, Nara 630-0293
Japan
Site Not Available
Kinki University - Nara Hospital
Ikoma 1861749, Nara 1855608 630-0293
Japan
Site Not Available
Saitama Prefectural Children's Medical Center
Saitama-shi, Saitama 1853226 330-8777
Japan
Site Not Available
Jichi Medical University Hospital
Shimotsuke, Tochigi 329 0498
Japan
Site Not Available
Jichi Medical University Hospital
Shimotsuke 6822175, Tochigi 1850310 329 0498
Japan
Site Not Available
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
Japan
Active - Recruiting
Japanese Red Cross Kyoto Daini Hospital
Kyoto, 602-8026
Japan
Active - Recruiting
Japanese Red Cross Kyoto Daini Hospital
Kyoto 1857910, 602-8026
Japan
Site Not Available
Saga University Hospital
Saga, 849-8501
Japan
Active - Recruiting
Saga University Hospital
Saga 1853303, 849-8501
Japan
Site Not Available
Toyama Prefectural Central Hospital
Toyama, 930-8550
Japan
Site Not Available
Toyama Prefectural Central Hospital
Toyama 1849876, 930-8550
Japan
Site Not Available
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
Warsaw, Masovian Voivodeship 04-730
Poland
Active - Recruiting
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship 04-501
Poland
Active - Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
Warsaw 756135, Masovian Voivodeship 858787 04-730
Poland
Active - Recruiting
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw 756135, Masovian Voivodeship 858787 04-501
Poland
Active - Recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship 93-338
Poland
Site Not Available
Instytut Centrum Zdrowia Matki Polki
Lodz 3093133, Łódź Voivodeship 3337493 93-338
Poland
Site Not Available
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600
Poland
Site Not Available
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow, 30-663
Poland
Site Not Available
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow 3094802, 30-663
Poland
Site Not Available
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin, 71-434
Poland
Site Not Available
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin 3083829, 71-434
Poland
Site Not Available
Centrum Zdrowia MDM
Warsaw, 00-189
Poland
Active - Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
Poland
Active - Recruiting
Centrum Zdrowia MDM
Warsaw 756135, 00-189
Poland
Active - Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw 756135, 00-728
Poland
Site Not Available
Centrum Zdrowia MDM
Warszawa, 00-189
Poland
Site Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-369
Poland
Site Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw 3081368, 50-369
Poland
Site Not Available
Narodny ustav detskych chorob
Bratislava, Bratislava Region 833 40
Slovakia
Site Not Available
Narodny ustav detskych chorob
Bratislava 3060972, Bratislava Region 3343955 833 40
Slovakia
Site Not Available
Cliniq s.r.o.
Bratislava, 811 09
Slovakia
Site Not Available
Cliniq s.r.o.
Bratislava 3060972, 811 09
Slovakia
Site Not Available
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna 15706
Spain
Site Not Available
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela 3109642, A Coruna 15706
Spain
Site Not Available
Consorci Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona 08208
Spain
Site Not Available
Consorci Corporacio Sanitaria Parc Tauli
Sabadell 3111199, Barcelona 08208
Spain
Site Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Active - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona 3128760, 08035
Spain
Site Not Available
Hospital Reina Sofia
Cordoba, 14004
Spain
Site Not Available
Hospital Reina Sofia
Córdoba, 14004
Spain
Site Not Available
Hospital Reina Sofia
Córdoba 2519240, 14004
Spain
Site Not Available
Arkansas Children's
Little Rock, Arkansas 72202
United States
Site Not Available
Arkansas Children's (IP Address)
Little Rock, Arkansas 72202
United States
Site Not Available
Arkansas Children's
Little Rock 4119403, Arkansas 4099753 72202
United States
Site Not Available
Arkansas Children's (IP Address)
Little Rock 4119403, Arkansas 4099753 72202
United States
Site Not Available
Valley View Wellness Medical Center
Garden Grove, California 92845
United States
Site Not Available
Loma Linda Children's Hospital
Loma Linda, California 92354
United States
Site Not Available
Loma Linda University Clinical Trial Center
Loma Linda, California 92354
United States
Site Not Available
Loma Linda University Eye Institute
Loma Linda, California 92354
United States
Site Not Available
Loma Linda University Medical Center
Loma Linda, California 92354
United States
Site Not Available
Loma Linda University Pediatric Clinics
Loma Linda, California 92354
United States
Site Not Available
Childrens Hospital of Orange County
Orange, California 92868
United States
Site Not Available
Loma Linda University Children's Hospital Pediatric Specialty Clinics
San Bernardino, California 92408
United States
Site Not Available
University of California San Francisco
San Francisco, California 94158
United States
Active - Recruiting
University of California San Francisco,
San Francisco, California 94158
United States
Active - Recruiting
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
San Francisco, California 94158
United States
Site Not Available
Valley View Wellness Medical Center
Garden Grove 5351515, California 5332921 92845
United States
Site Not Available
Loma Linda Children's Hospital
Loma Linda 5367696, California 5332921 92354
United States
Site Not Available
Loma Linda University Clinical Trial Center
Loma Linda 5367696, California 5332921 92354
United States
Site Not Available
Loma Linda University Eye Institute
Loma Linda 5367696, California 5332921 92354
United States
Site Not Available
Loma Linda University Medical Center
Loma Linda 5367696, California 5332921 92354
United States
Site Not Available
Loma Linda University Pediatric Clinics
Loma Linda 5367696, California 5332921 92354
United States
Site Not Available
Loma Linda University Children's Hospital Pediatric Specialty Clinics
San Bernardino 5391710, California 5332921 92408
United States
Site Not Available
University of California San Francisco
San Francisco 5391959, California 5332921 94158
United States
Active - Recruiting
University of California San Francisco,
San Francisco 5391959, California 5332921 94158
United States
Site Not Available
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
San Francisco 5391959, California 5332921 94158
United States
Active - Recruiting
IHS Health Research
Kissimmee, Florida 34741
United States
Site Not Available
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
Orlando, Florida 32806
United States
Active - Recruiting
Nemours Children's Hospital
Orlando, Florida 32827
United States
Active - Recruiting
Kissimmee Endoscopy Center
Windermere, Florida 34741
United States
Site Not Available
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
Orlando 4167147, Florida 4155751 32806
United States
Site Not Available
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia 30342
United States
Site Not Available
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Active - Recruiting
University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
United States
Site Not Available
Boston Children's Hospital
Boston, Massachusetts 02115
United States
Active - Recruiting
Boston Children's Hospital
Boston 4930956, Massachusetts 6254926 02115
United States
Site Not Available
Beaumont Hospital
Royal Oak, Michigan 48073
United States
Active - Recruiting
William Beaumont Hospital
Royal Oak, Michigan 48073
United States
Site Not Available
William Beaumont Hospital/Corewell Health - East
Royal Oak, Michigan 48073
United States
Active - Recruiting
William Beaumont Hospitals Reference Laboratory
Royal Oak, Michigan 48073
United States
Active - Recruiting
William Beaumont Hospital
Royal Oak 5007804, Michigan 5001836 48073
United States
Site Not Available
William Beaumont Hospitals Reference Laboratory
Royal Oak 5007804, Michigan 5001836 48073
United States
Active - Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Site Not Available
University of Rochester Medical Center
Rochester, New York 14642
United States
Active - Recruiting
University of Rochester Medical Center Clinical Research Center
Rochester, New York 14642
United States
Site Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Active - Recruiting
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio 44106
United States
Active - Recruiting
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United States
Site Not Available
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
Cleveland 5150529, Ohio 5165418 44106
United States
Active - Recruiting
East Tennessee Children's Hospital
Knoxville, Tennessee 37916
United States
Active - Recruiting
GI for Kids
Knoxville, Tennessee 37922
United States
Site Not Available
Statcare Pulmonary
Knoxville, Tennessee 37919
United States
Active - Recruiting
Tennessee Eye Care
Knoxville, Tennessee 37909
United States
Active - Recruiting
Tennova
Knoxville, Tennessee 37934
United States
Active - Recruiting
ACT-Midwest G1
Abilene, Texas 79606
United States
Site Not Available
Advance Clinical Trial PLLC
Abilene, Texas 79606
United States
Site Not Available
DCT - Midwest GI
Abilene, Texas 79606
United States
Site Not Available
Advance Clinical Trial PLLC
Abilene 4669635, Texas 4736286 79606
United States
Site Not Available

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A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Phase

Condition

Treatment

Clinical Study ID

Study Summary

Eligibility Criteria

Inclusion

Exclusion

Study Design

Connect with a study center

Landeskrankenhaus Salzburg

Landeskrankenhaus Salzburg

UZ Leuven

University Hospitals Leuven

University Hospitals Leuven

Tsujinaka Hospital - Kashiwanoha

Tsujinaka Hospital - Kashiwanoha

Ishii Eye Clinic

Gunma University Hospital

Gunma University Hospital

Hyogo Medical University Hospital

Hyogo Medical University Hospital

Kinki University - Nara Hospital

Kinki University - Nara Hospital

Kinki University - Nara Hospital

Saitama Prefectural Children's Medical Center

Jichi Medical University Hospital

Jichi Medical University Hospital

Juntendo University Hospital

Japanese Red Cross Kyoto Daini Hospital

Japanese Red Cross Kyoto Daini Hospital

Saga University Hospital

Saga University Hospital

Toyama Prefectural Central Hospital

Toyama Prefectural Central Hospital

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

WIP Warsaw IBD Point Profesor Kierkuś

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

WIP Warsaw IBD Point Profesor Kierkuś

Instytut Centrum Zdrowia Matki Polki

Instytut Centrum Zdrowia Matki Polki

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

Uniwersytecki Szpital Dziecięcy w Krakowie

Uniwersytecki Szpital Dziecięcy w Krakowie

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Centrum Zdrowia MDM

WIP Warsaw IBD Point Profesor Kierkus

Centrum Zdrowia MDM

WIP Warsaw IBD Point Profesor Kierkus

Centrum Zdrowia MDM

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Narodny ustav detskych chorob

Narodny ustav detskych chorob

Cliniq s.r.o.

Cliniq s.r.o.

Hospital Clinico Universitario de Santiago de Compostela

Hospital Clinico Universitario de Santiago de Compostela

Consorci Corporacio Sanitaria Parc Tauli

Consorci Corporacio Sanitaria Parc Tauli

Hospital Universitari Vall d'Hebron

Hospital Universitari Vall d'Hebron

Hospital Reina Sofia

Hospital Reina Sofia

Hospital Reina Sofia

Arkansas Children's

Arkansas Children's (IP Address)

Arkansas Children's

Arkansas Children's (IP Address)

Valley View Wellness Medical Center

Loma Linda Children's Hospital

Loma Linda University Clinical Trial Center

Loma Linda University Eye Institute

Loma Linda University Medical Center

Loma Linda University Pediatric Clinics

Childrens Hospital of Orange County

Loma Linda University Children's Hospital Pediatric Specialty Clinics

University of California San Francisco