Menu
Recruiting NCT07470879

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

Phase II Interventional Colitis, Ulcerative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Etrasimod.
Who it may be relevant to
Registry conditions: Colitis, Ulcerative. Basic parameters: 2 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, France, Germany, Israel, Italy +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A PHASE 2 OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS, AND SAFETY OF ETRASIMOD IN PEDIATRIC PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Overview

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).

Interventions

  • Drug Etrasimod
    Once daily by mouth

Primary outcome measures

  • Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 [Time frame: Week 52]
Secondary outcome measures (12)
  • Number and percent of enrolled participants with clinical remission based on MMS at Week 12 [Time frame: Week 12]
  • Number and percent of enrolled participants with clinical response based on MMS score components at Week 12 [Time frame: Week 12]
  • Number and percent of enrolled participants with clinical response based on MMS score components at Week 52 [Time frame: Week 52]
  • Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 12 [Time frame: Week 12]
  • Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 52 [Time frame: Week 52]
  • Number and percent of enrolled participants Clinical remission at Week 12 and who had not been receiving corticosteroids for ≥2 weeks immediately prior to Week 12 [Time frame: Week 12]
  • Number and percent of enrolled participants Clinical remission at Week 52 and who had not been receiving corticosteroids for ≥12 weeks immediately prior to Week 52 [Time frame: Week 52]
  • Number and percent of enrolled participants Symptomatic remission at all time points up to Week 52 [Time frame: Week 52]
  • Number and percent of enrolled participants Pediatric Ulcerative Colitis Activity Index (PUCAI) clinical remission from baseline to Week 260 [Time frame: Baseline, through Week 260]
  • Number and percent of enrolled participants PUCAI clinical response from baseline to Week 260 [Time frame: Baseline, through Week 260]
  • Number and percentage of participants reporting a positive taste/palatability score [Time frame: Week 2]
  • Number and percentage of participants reporting a positive taste/palatability score [Time frame: Week 12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 5 centers
  • Sheba Medical Center — Ramat Gan
  • Yitzhak Shamir Medical Center — Ẕerifin
  • Shaare Zedek Medical Center — Jerusalem
  • Hadassah Medical Center — Jerusalem
  • Rambam Health Care Campus — Haifa
Germany · 4 centers
  • Universitätsklinikum Münster - Albert Schweitzer Campus — Münster
  • Universitätsklinikum Leipzig — Leipzig
  • Universitaetsklinikum Tuebingen — Tübingen
  • HELIOS Klinikum Wuppertal — Wuppertal
Poland · 4 centers
  • Centrum Zdrowia MDM — Warsaw
  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw
  • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero — Katowice
  • Instytut "Pomnik - Centrum Zdrowia Dziecka" — Warsaw
Canada · 3 centers
  • Health Sciences Centre Winnipeg — Winnipeg
  • Children's Hospital Research Institute of Manitoba — Winnipeg
  • CHU de Québec - Université Laval — Québec
Japan · 3 centers
  • Saitama Prefectural Children's Medical Center — Saitama-shi
  • Japanese Red Cross Kumamoto Hospital — Kumamoto
  • Juntendo University Hospital — Tokyo
United Kingdom · 3 centers
  • King's College Hospital — London
  • Evelina London Children's Hospital — London
  • Sheffield Children's Hospital — Sheffield
France · 2 centers
  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant — Bron
  • Hôpital Universitaire Necker Enfants Malades — Paris
Italy · 1 center
  • Azienda Ospedaliera Universitaria Meyer IRCCS — Florence

Identifiers

NCT: NCT07470879 · C5041018 · APD334-208 · 2025-523100-77-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗