A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease
A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Inclusion criteria:
Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 but less than or equal to (<=) 450
Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) >= 4 (for participants with isolated ileal disease) or >= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:
In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol
Exclusion criteria
Participate-In-This-Study1@its.jnj.com844-434-4210
Charlotte, North Carolina 28207, United States
Summerville, South Carolina 29486, United States
Hradec Kralova, 500 02, Czechia
Ostrava-Poruba, 708 00, Czechia
Hilleroed, 3400, Denmark
Vandœuvre-lès-Nancy, 54511, France
Berlin, 12203, Germany
Grevenbroich, 41515, Germany
Torun, 87 100, Poland
Warsaw, 02-781, Poland
Navarra, 31008, Spain
Greater London, E1 2AJ, United Kingdom
Greater London, NW10 7NS, United Kingdom
Iselworth, TW7 6AF, United Kingdom