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Clinical Trials in France / 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 France tracker
Sponsor
Pfizer
Phase
Phase 2
Started
2026-05-28
Last updated
2026-08-24

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 (42)

FacilityCityRegionStatus
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
Monash Health Clayton Victoria Recruiting
Perth Children's Hospital Perth Western Australia 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 Auvergne-Rhône-Alpes Recruiting
Hôpital Universitaire Necker Enfants Malades Paris France Recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus 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 Pharmacy Rehovot Central District Recruiting
Kaplan Medical Center Rehovot Central District Recruiting
Yitzhak Shamir Medical Center Ẕerifin 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 Not Yet Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Tuscany Not Yet 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
Instytut "Pomnik - Centrum Zdrowia Dziecka" Warsaw Poland Recruiting
King's College Hospital London London, CITY of Recruiting
Bristol Royal Hospital for Children Bristol United Kingdom Not Yet Recruiting
Alder Hey Children's Hospital Liverpool United Kingdom Recruiting

+ 2 more sites — see the full list on the official registry below.

More Pfizer trials in France

Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis Active, not recruiting
A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis. Recruiting
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. Recruiting
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC Active, not recruiting
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects Recruiting

Other trials for the same condition

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants Recruiting
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis Recruiting
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis Recruiting
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis 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 NCT07470879 on ClinicalTrials.gov ↗ ← All trials in France