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
Janssen Research & Development, LLC
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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)…
Interventions
- DrugGuselkumab
Guselkumab will be administered.
- DrugRisankizumab
Risankizumab will be administered.
Locations (11)
- Clinnova ResearchAnaheim, California
- TLC Clinical Research IncLos Angeles, California
- Peak Gastroenterology AssociatesColorado Springs, Colorado
- Sanchez Clinical Research, IncMiami, Florida
- GCP Clinical ResearchTampa, Florida
- Cotton-O'Neil Clinical Research CenterTopeka, Kansas