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A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
NCT05287126 · Pfizer
In plain English
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Official title
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
About this study
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 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
Study design
Enrollment target: 36 participants
Allocation: na
Masking: none
Age groups: child
Timeline
Starts: 2022-12-16
Estimated completion: 2033-07-10
Last updated: 2026-03-30
Interventions
Drug: Etrasimod
Primary outcomes
- • Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 (Week 52)
Sponsor
Pfizer · industry
With: Arena is a wholly owned subsidiary of Pfizer
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (47)
Arkansas Children's (IP Address)Not Yet Recruiting
Little Rock, Arkansas, United States
Arkansas Children'sNot Yet Recruiting
Little Rock, Arkansas, United States
Valley View Wellness Medical CenterRecruiting
Garden Grove, California, United States
Loma Linda Children's HospitalNot Yet Recruiting
Loma Linda, California, United States
Loma Linda University Clinical Trial CenterNot Yet Recruiting
Loma Linda, California, United States
Loma Linda University Eye InstituteNot Yet Recruiting
Loma Linda, California, United States
Loma Linda University Medical CenterNot Yet Recruiting
Loma Linda, California, United States
Loma Linda University Pediatric ClinicsNot Yet Recruiting
Loma Linda, California, United States
Loma Linda University Children's Hospital Pediatric Specialty ClinicsNot Yet Recruiting
San Bernardino, California, United States
University of California San Francisco,Recruiting
San Francisco, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)Recruiting
San Francisco, California, United States
Arnold Palmer Hospital - Center for Digestive Health and NutritionRecruiting
Orlando, Florida, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Boston Children's HospitalRecruiting
Boston, Massachusetts, United States
William Beaumont Hospital/Corewell Health - EastRecruiting
Royal Oak, Michigan, United States
William Beaumont Hospitals Reference LaboratoryRecruiting
Royal Oak, Michigan, United States
University Hospitals Cleveland Medical Center Rainbow Babies & Children's HospitalRecruiting
Cleveland, Ohio, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
ACT-Midwest G1Recruiting
Abilene, Texas, United States
Landeskrankenhaus SalzburgRecruiting
Salzburg, Austria
University Hospitals LeuvenRecruiting
Leuven, Belgium
Tsujinaka Hospital - KashiwanohaRecruiting
Kashiwa, Chiba, Japan
Ishii Eye ClinicRecruiting
Nagareyama-shi, Chiba, Japan
Gunma University HospitalRecruiting
Maebashi, Gunma, Japan
Hyogo Medical University HospitalRecruiting
Nishinomiya, Hyōgo, Japan
Kinki University - Nara HospitalRecruiting
Ikoma, Nara, Japan
Saitama Prefectural Children's Medical CenterRecruiting
Saitama-shi, Saitama, Japan
Jichi Medical University HospitalRecruiting
Shimotsuke, Tochigi, Japan
Juntendo University HospitalRecruiting
Bunkyo-ku, Tokyo, Japan
Japanese Red Cross Kyoto Daini HospitalRecruiting
Kyoto, Japan
Saga University HospitalRecruiting
Saga, Japan
Toyama Prefectural Central HospitalRecruiting
Toyama, Japan
WIP Warsaw IBD Point Profesor KierkuśRecruiting
Warsaw, Masovian Voivodeship, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)Recruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Dziecięcy w KrakowieRecruiting
Krakow, Poland
Twoja Przychodnia - Szczecińskie Centrum MedyczneRecruiting
Szczecin, Poland
Centrum Zdrowia MDMRecruiting
Warsaw, Poland
WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuRecruiting
Wroclaw, Poland
Instytut Centrum Zdrowia Matki PolkiRecruiting
Lodz, Łódź Voivodeship, Poland
Narodny ustav detskych chorobNot Yet Recruiting
Bratislava, Bratislava Region, Slovakia
Cliniq s.r.o.Not Yet Recruiting
Bratislava, Slovakia
Hospital Clinico Universitario de Santiago de CompostelaNot Yet Recruiting
Santiago de Compostela, A Coruna, Spain
Consorci Corporacio Sanitaria Parc TauliRecruiting
Sabadell, Barcelona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Reina SofiaNot Yet Recruiting
Córdoba, Spain