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NCT05287126RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
36 (estimated)
First submitted
10 Mar 2022
Start date
16 Dec 2022
Primary completion date
16 Jun 2029
Lead sponsor
Pfizer
NCT number
NCT05287126
EU CT number
2022-500345-25-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 36
  • From 16 Dec 2022 to the primary completion date, 16 Jun 2029
  • 50 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD

Other

  • Severe extensive colitis
  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Who the study is looking for

  • 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

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
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SalzburgAustriaCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Parc Tauli Hospital Universitari
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SabadellSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Juntendo University Hospital
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Bunkyo-kuJapanRecruiting
Kinki University - Nara Hospital
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IkomaJapanRecruiting
Tsujinaka Hospital Kashiwanoha
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KashiwaJapanRecruiting
Japanese Red Cross Kyoto Daini Hospital
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KyotoJapanRecruiting
Gunma University Hospital
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MaebashiJapanRecruiting
Ishii Eye Clinic
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Nagareyama-shiJapanRecruiting
Hyogo Medical University Hospital
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NishinomiyaJapanRecruiting
Saga University Hospital
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SagaJapanRecruiting
Saitama Prefectural Children's Medical Center
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Saitama-ShiJapanRecruiting
Jichi Medical University Hospital
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ShimotsukeJapanRecruiting
Toyama Prefectural Central Hospital
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ToyamaJapanRecruiting
Uniwersytecki Szpital Dzieciecy W Krakowie
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CracowPolandRecruiting
Gyncentrum Sp. z o.o.
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KatowicePolandRecruiting
Instytut Centrum Zdrowia Matki Polki
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LodzPolandRecruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
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SzczecinPolandRecruiting
EB GROUP Spółka Z Ograniczoną Odpowiedzialnością Centrum Zdrowia MDM
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WarsawPolandRecruiting
Instytut Pomnik Centrum Zdrowia Dziecka
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WarsawPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
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WroclawPolandRecruiting
University Hospital Bratislava
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BratislavaSlovakiaRecruiting
Cliniq s.r.o.
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BratislavaSlovakiaRecruiting
Detská fakultná nemocnica Košice
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KošiceSlovakiaRecruiting
KM Management spol. s r.o.
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NitraSlovakiaRecruiting
ACT-Midwest G1
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AbileneUnited StatesRecruiting
Boston Children's Hospital
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BostonUnited StatesRecruiting
University of Chicago Medical Center
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ChicagoUnited StatesRecruiting
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
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ClevelandUnited StatesRecruiting
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesRecruiting
Cook Children's Medical Center
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Fort WorthUnited StatesRecruiting
Cook Children's Health Care System-Dodson Specialty Clinics
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Fort WorthUnited StatesRecruiting
Valley View Wellness Medical Center
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Garden GroveUnited StatesRecruiting
Arkansas Children's
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Little RockUnited StatesNot yet recruiting
Arkansas Children's (IP Address)
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Little RockUnited StatesNot yet recruiting
Loma Linda University Clinical Trial Center
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Loma LindaUnited StatesNot yet recruiting
Loma Linda Children's Hospital
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Loma LindaUnited StatesNot yet recruiting
Loma Linda University Eye Institute
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Loma LindaUnited StatesNot yet recruiting
Loma Linda University Pediatric Clinics
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Loma LindaUnited StatesNot yet recruiting
Loma Linda University Medical Center
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Loma LindaUnited StatesNot yet recruiting
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
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OrlandoUnited StatesRecruiting
William Beaumont Hospitals Reference Laboratory
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Royal OakUnited StatesRecruiting
William Beaumont Hospital/Corewell Health - East
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Royal OakUnited StatesRecruiting
Loma Linda University Children's Hospital Pediatric Specialty Clinics
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San BernardinoUnited StatesNot yet recruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
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San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.