Vedolizumab in Pediatric Patients

Condition: Ulcerative colitis, Crohn's disease

Eligibility

Key Inclusion Criteria

  • Weighs ≥10 kg
  • 2-17 years old, with moderately to severely active UC or CD diagnosed at least 3 months before screening

Key Exclusion Criteria

  • Previous exposure to approved or investigational anti-integrin therapy
  • Previous exposure to vedolizumab

Full Study Name

Takeda - Vedolizumab Phase II in Pediatric Patients With Ulcerative Colitis or Crohn's Disease (IRB no. 48074)

Summary

This study focuses on children diagnosed with either Crohn’s disease (CD) or ulcerative colitis (UC) and who are between the ages of 2 and 17. The purpose of the study is to examine how a drug called vedolizumab is processed by the body in these children. Researchers also aim to evaluate whether vedolizumab is safe and effective for the treatment of UC and CD in children and to determine which dose may be best. Vedolizumab belongs to a group of proteins called antibodies, which help to reduce inflammation that can cause the symptoms in CD and UC. The use of vedolizumab in this study is investigational.

Phase

Phase II

Principal Investigator

Shervin Rabizadeh, MD

Contact
Yogesh Arora
Phone: 310-248-8516
Email: yogesh.arora@cshs.org