Crohn’s Disease Maintenance Therapy with Vedolizumab – Phase III

Study to Evaluate Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Protocol Description

The purpose of this multi-center study of is to evaluate use of vedolizumab as a maintenance therapy for children and teens with Crohn’s disease, a long-term disease that results in inflammation of the intestine. Standard treatments include medicines, such as steroids, and biologic therapies that work in different ways to reduce inflammation. The study drug has been approved for treatment of Crohn’s in adults and is still being tested with pediatric patients to determine best dosing levels, effectiveness, and side effects.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to pediatric patients with moderately to severely active Crohn’s disease, whose condition was not treatable through the current standard of care.
Boys and Girls: Ages 2 through 17 years


About 13 visits will be required for the various study stages – screening, induction, maintenance, and follow-up. During visits, physical exams and tests will be provided, including up to 3 colonoscopies during the study period, and the study drug will be given intravenously at specified visits 3 times during the 10-week induction period and 5 times during the 44-week maintenance period. Participants who show improvement in clinical response at 54 weeks, may be invited by their study doctor to continue in a separate extension study for up to 5 years.
Visits: About 13
Duration: About 14 months, with follow-up phone calls every 6 months for 2 years after the last dose of the study drug

Status: Open to Enrollment

Source(s) of Support

Takeda Development Center Americas

Primary Investigator

Whitney Sunseri, MD

Contact Information

For more information about the study or enrollment, please contact:
Susan Richey, RN, Clinical Research Nurse Coordinator