Clinical Research Details

Clinical Research

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Study Description

This research study is for people who have moderately to severely active Ulcerative Colitis (UC). The study is known as the QUASAR study and consists of 3 distinct study phases; Induction, Maintenance, and Long-Term Extension (LTE) of the Maintenance Study.

The main purpose of the QUASAR study is to see if a drug called "guselkumab" is safe and effective in treating UC. Another purpose is to determine how long guselkumab stays in and acts on the body. Individual who joins the QUASAR study will undergo a Screening process which will last a maximum period of 8 weeks to determine if the individual qualifies to participate, before enrolling into the Induction Study (either 1 or 2) for a maximum of 24 weeks. If UC symptoms improve based on certain criteria, and the participant remains eligible according to other study requirements, then the participant will be able to enter the Maintenance Study for 44 weeks. After completion of the Maintenance Study and if, in the opinion of the investigator, the participant may benefit from continued study drug treatment, the participant will have the opportunity to take part in the LTE of the Maintenance Study for up to an additional 2 years.

Open Enrollment

Contact Name: Kelly Jackman
Contact Phone: (904) 633-0070
Contact Email: kelly.jackman@jax.ufl.edu

Investigators


Principal Investigator
Ron Schey, M.D.
Medicine

Sub Investigator
Maged P. Ghali, M.D.
Medicine