Crohn’s Disease and Ulcerative Colitis Treatment with Etrolizumab – Phase I

Study Of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease

Protocol Description

The purpose of this multi-center research study is to evaluate the effects of etrolizumab in pediatric patients with ulcerative colitis or Crohn’s disease. Researchers primarily will be measuring the pharmacokinetics – how the body processes the drug – and its side effects, while also monitoring its effects on inflammation caused by these conditions. Etrolizumab is designed to block the binding of certain white blood cells to the lining of the gastrointestinal tract, which is thought to reduce the inflammation caused by ulcerative colitis or Crohn’s disease.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting patients of both genders, ages 4 through 17 years, diagnosed with moderate to severe ulcerative colitis or moderate to severe Crohn’s disease.
Boys and Girls: Ages 4 through 17 years

Requirements

Participants will be randomly assigned into one of two groups. One will receive an injection of the study drug every 4 weeks and the other will receive the drug at twice the dosage level, but at 8-week intervals. In both groups, etrolizumab will be administered over a period of 16 weeks followed by an 8-week safety follow up period. During visits for injections, researchers will collect blood, urine and stool samples for analysis. At the end of 24 weeks, participants will have the option of continuing in a study extension in which they will receive the study drug every 4 weeks for a period of 108 weeks. When participants are no longer receiving etrolizumab they will be followed by the research team via telephone every 6 months for 2 years.
Visits: 4 to 6 over 16 weeks, plus an additional 27 for participants who join the study extension
Duration: About 2-1/2 years, or 4-1/2 years for those who join the study extension

Status: Enrollment Pending

Source(s) of Support

F. Hoffman-La Roche Ltd.

Primary Investigator

David Keljo, MD

Contact Information

For more information about the study or enrollment, please contact:
Amy Bookser, RN
412-692-8453
or
Kathleen Calabro RN, BSN
412-692-6092