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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-11
SponsorPfizer

About this trial

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 criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Etrasimod

Treatment groups

24 Participants
are divided into 1 treatment group

Locations

25
Canada
Children's Hospital Research Institute of ManitobaR3E 3P4, WinnipegManitoba, Canada
Health Sciences Centre WinnipegR3A 1S1, WinnipegManitoba, Canada
CHU de Québec - Université LavalG1V4G2, QuébecQuebec, Canada
France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant69500, BronAuvergne-Rhône-Alpes, France

Sponsors and collaborators

Pfizer

Lead sponsor