Research Study for Crohn's Disease

UVA Tracking #
HSR200149
Principal Investigator
Anne G Tuskey
Contact
Lakin Underwood
Contact Phone
434.243.6156
Official Trial Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease
Study Description

The Department of Gastroenterology seeks adults ages 18 and older with Crohn’s disease for a research study. The purpose of the study is to see how safe and effective a new medication, mirikizumab, is at treating Crohn’s disease as compared to an already approved drug, ustekinumab, and whether you might have any side effects when you take it.

You may be eligible for this study if: you have moderate to severe Crohn’s disease and you have tried other medications for your Crohn’s disease and they have not worked.

Study involves up to 18 visits to UVA over 73 weeks, up to 3 colonoscopies, taking a new, unapproved drug (mirikizumab), an already approved drug (ustekinumab) or placebo as an infusion or an injection for 52 weeks, completing an electronic diary about your Crohn’s symptoms daily, providing stool samples.

Study-related exams, tests and experimental medication are all provided free of charge.

Compensation

You will be compensated monthly for completing your electronic diary as well as for traveling to your study visits.