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Clinical Trials in Spain / NCT05287126
Recruiting Phase 2

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

NCT05287126 · tracked via the Priya Life Science Spain tracker
Sponsor
Pfizer
Phase
Phase 2
Started
2022-12-16
Last updated
2026-07-08

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Etrasimod →

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

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

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 — Week 52

Trial sites (45)

FacilityCityRegionStatus
Arkansas Children's (IP Address) Little Rock Arkansas Not Yet Recruiting
Arkansas Children's Little Rock Arkansas Not Yet Recruiting
Valley View Wellness Medical Center Garden Grove California Recruiting
Loma Linda Children's Hospital Loma Linda California Not Yet Recruiting
Loma Linda University Clinical Trial Center Loma Linda California Not Yet Recruiting
Loma Linda University Eye Institute Loma Linda California Not Yet Recruiting
Loma Linda University Medical Center Loma Linda California Not Yet Recruiting
Loma Linda University Pediatric Clinics Loma Linda California Not Yet Recruiting
Loma Linda University Children's Hospital Pediatric Specialty Clinics San Bernardino California Not Yet Recruiting
University of California San Francisco, San Francisco California Recruiting
University of California San Francisco San Francisco California Recruiting
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC) San Francisco California Recruiting
Arnold Palmer Hospital - Center for Digestive Health and Nutrition Orlando Florida Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Boston Children's Hospital Boston Massachusetts Recruiting
William Beaumont Hospital/Corewell Health - East Royal Oak Michigan Recruiting
William Beaumont Hospitals Reference Laboratory Royal Oak Michigan Recruiting
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital Cleveland Ohio Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
ACT-Midwest G1 Abilene Texas Recruiting
Tsujinaka Hospital - Kashiwanoha Kashiwa Chiba Recruiting
Ishii Eye Clinic Nagareyama-shi Chiba Recruiting
Gunma University Hospital Maebashi Gunma Recruiting
Hyogo Medical University Hospital Nishinomiya Hyōgo Recruiting
Kinki University - Nara Hospital Ikoma Nara Recruiting
Saitama Prefectural Children's Medical Center Saitama-shi Saitama Recruiting
Jichi Medical University Hospital Shimotsuke Tochigi Recruiting
Juntendo University Hospital Bunkyo-ku Tokyo Recruiting
Japanese Red Cross Kyoto Daini Hospital Kyoto Japan Recruiting
Saga University Hospital Saga Japan Recruiting
Toyama Prefectural Central Hospital Toyama Japan Recruiting
WIP Warsaw IBD Point Profesor Kierkuś Warsaw Masovian Voivodeship Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute) Warsaw Masovian Voivodeship Recruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero Katowice Poland Not Yet Recruiting
Uniwersytecki Szpital Dziecięcy w Krakowie Krakow Poland Recruiting
Twoja Przychodnia - Szczecińskie Centrum Medyczne Szczecin Poland Recruiting
Centrum Zdrowia MDM Warsaw Poland Recruiting
WIP Warsaw IBD Point Profesor Kierkus Warsaw Poland Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw Poland Recruiting
Instytut Centrum Zdrowia Matki Polki Lodz Łódź Voivodeship Active Not Recruiting

+ 5 more sites — see the full list on the official registry below.

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BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies Recruiting
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease Active, not recruiting
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects Recruiting
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer Active, not recruiting

Other trials for the same condition

A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Recruiting
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis. Active, not recruiting
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD) Recruiting
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: Recruiting
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05287126 on ClinicalTrials.gov ↗ ← All trials in Spain