Etrasimod treatment for children with moderately to severely active ulcerative colitis

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

This trial tests whether the medicine etrasimod is safe and helps children ages 2 to under 12 with moderately to severely active ulcerative colitis.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 2 Years to 11 Years
• Sex: All
• Sponsor: Pfizer (industry)
• Locations: 9 sites (Québec, Quebec and 8 other locations)
• Trial ID: NCT07470879 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives pediatric participants etrasimod and follows them closely for safety, effectiveness, and how the drug is processed in the body (pharmacokinetics) over a 52-week treatment period. Children who complete the 52 weeks may continue in a long-term extension for up to four additional years (five years total after enrollment). The study enrolls participants with moderately to severely active ulcerative colitis and permits some background UC therapies while excluding patients with Crohn’s disease, fistulas, severe extensive colitis, or other non-UC colitis types. Visits and monitoring occur at academic medical centers in Canada and Germany under sponsorship by Pfizer.

Who should consider this trial

Good fit: Children aged 2 up to just under 12 years with a diagnosis of moderately to severely active ulcerative colitis who meet health criteria and are eligible under the study’s medication and medical history rules are ideal candidates.

Not a fit: Patients with Crohn’s disease, indeterminate colitis, history of fistulas, severe extensive colitis, or microscopic/ischemic/infectious colitis are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, etrasimod could provide a new oral treatment option to reduce inflammation and symptoms in children with moderately to severely active ulcerative colitis.

How similar studies have performed: Previous adult trials of etrasimod and other S1P receptor modulators have shown clinical benefit in ulcerative colitis, so this pediatric study builds on existing adult data.

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

Where this trial is running

Québec, Quebec and 8 other locations

• CHU de Québec - Université Laval — Québec, Quebec, Canada (RECRUITING)
• Universitätsklinikum Leipzig — Leipzig, Saxony, Germany (NOT_YET_RECRUITING)
• Universitaetsklinikum Tuebingen — Tübingen, Germany (NOT_YET_RECRUITING)
• Saitama Prefectural Children's Medical Center — Saitama-shi, Saitama, Japan (RECRUITING)
• Japanese Red Cross Kumamoto Hospital — Kumamoto, Japan (RECRUITING)
• Juntendo University Hospital — Tokyo, Japan (RECRUITING)
• Centrum Zdrowia MDM — Warsaw, Masovian Voivodeship, Poland (NOT_YET_RECRUITING)
• Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw, Masovian Voivodeship, Poland (RECRUITING)
• Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero — Katowice, Poland (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions: Colitis, Ulcerative, ulcerative, colitis, ulcerative colitis, etrasimod, pediatrics