Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the UK / NCT07470879
Recruiting Phase 2

A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis

NCT07470879 · tracked via the Priya Life Science UK tracker
Sponsor
Pfizer
Phase
Phase 2
Started
2026-05-28
Last updated
2026-10-26

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

Etrasimod →

Etrasimod: Once daily by mouth

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 pediatrics participants (≥ 2 years up to \< 12 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
2 Years
Max age
11 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)

  • Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 — Week 52
    Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.

Trial sites (46)

FacilityCityRegionStatus
Investigational Drug Services - Riley Hospital Indianapolis Indiana Recruiting
IU Health North Hospital Indianapolis Indiana Recruiting
Riley Hospital for Children at IU Health Indianapolis Indiana Recruiting
Fink Children's Ambulatory Care Center New York New York Recruiting
Kimmel Pavilion - NYU Langone New York New York Recruiting
NYU Grossman School of Medicine New York New York Recruiting
NYU Langone Health (Tisch Hospital) New York New York Recruiting
NYU Langone Inflammatory Bowel Disease Center New York New York Recruiting
NYU Langone Radiology - Tisch Hospital New York New York Recruiting
NYU Medical Science Building (MSB) New York New York Recruiting
The Children's Hospital at Westmead Westmead New South Wales Recruiting
Queensland Children's Hospital Brisbane Queensland Recruiting
Monash Health Clayton Victoria Recruiting
Perth Children's Hospital Perth Western Australia Recruiting
University of Alberta Edmonton Alberta Not Yet Recruiting
Health Sciences Centre Winnipeg Winnipeg Manitoba Recruiting
Children's Hospital Research Institute of Manitoba Winnipeg Manitoba Recruiting
CHU de Québec - Université Laval Québec Quebec Recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant Bron France Recruiting
Hôpital Universitaire Necker Enfants Malades Paris France Recruiting
Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin Albert-Schweitzer-Campus 1 Münster North Rhine-Westphalia Recruiting
Universitätsklinikum Leipzig Leipzig Saxony Recruiting
Universitaetsklinikum Tuebingen Tübingen Germany Recruiting
HELIOS Klinikum Wuppertal Wuppertal Germany Recruiting
Sheba Medical Center Ramat Gan Central District Recruiting
Kaplan Medical Center Rehovot Central District Recruiting
Yitzhak Shamir Medical Center Tsrifin Central District Recruiting
Shaare Zedek Medical Center Jerusalem Jerusalem Recruiting
Hadassah Medical Center Jerusalem Jerusalem Recruiting
Rambam Health Care Campus Haifa Northern District Recruiting
Carmel Medical Center Haifa Northern District Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo Lombardy Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Lombardy Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Tuscany Recruiting
Saitama Prefectural Children's Medical Center Saitama-shi Saitama Recruiting
Japanese Red Cross Kumamoto Hospital Kumamoto Japan Recruiting
Juntendo University Hospital Tokyo Japan Recruiting
Centrum Zdrowia MDM Warsaw Masovian Voivodeship Recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś Warsaw Masovian Voivodeship Recruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero Katowice Poland Recruiting

+ 6 more sites — see the full list on the official registry below.

More Pfizer trials in the UK

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis Active, not recruiting
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma Active, not recruiting
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC Active, not recruiting
A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer Active, not recruiting

Other trials for the same condition

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis Recruiting
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease Active, not recruiting
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) Recruiting
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis Active, not recruiting
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK) 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 NCT07470879 on ClinicalTrials.gov ↗ ← All trials in the UK