A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Guselkumab: Guselkumab will be administered.
Risankizumab: Risankizumab will be administered.
Study 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
Primary outcome measure(s)
- Number of Participants with Deep Remission at Week 52 — At Week 52
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn's Disease Activity Index (CDAI) score less than (\<) 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no sub score greater than (\>) 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
Trial sites (161)
| Facility | City | Region | Status |
|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | Recruiting |
| East View Medical Research | Mobile | Alabama | Recruiting |
| Clinnova Research | Anaheim | California | Recruiting |
| Gastro Care Institute | Lancaster | California | Recruiting |
| United Gastroenterologists | Los Alamitos | California | Recruiting |
| TLC Clinical Research Inc | Los Angeles | California | Recruiting |
| GastroIntestinal Bioscience | Los Angeles | California | Recruiting |
| Hoag Memorial Hospital | Newport Beach | California | Suspended |
| Medical Associates Research Group, Inc. | San Diego | California | Recruiting |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | Recruiting |
| Medical Research Center of Connecticut | Hamden | Connecticut | Recruiting |
| Green Leaf Clinical Trials | Jacksonville | Florida | Recruiting |
| Sanchez Clinical Research, Inc | Miami | Florida | Recruiting |
| Biodax Medical Research Trials | Miami | Florida | Recruiting |
| GI Pros Research | Naples | Florida | Recruiting |
| GCP Clinical Research | Tampa | Florida | Recruiting |
| Morehouse School of Medicine | Atlanta | Georgia | Recruiting |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | Suspended |
| Gastroenterology Associates of Central GA | Macon | Georgia | Recruiting |
| Heartland Medical Research Inc | Clive | Iowa | Recruiting |
| Cotton-O'Neil Clinical Research Center | Topeka | Kansas | Recruiting |
| Gastroenterology Clinic of Acadiana | Lafayette | Louisiana | Recruiting |
| Woodholme Gastroenterology Associates | Glen Burnie | Maryland | Recruiting |
| Lucida Clinical Trials | New Bedford | Massachusetts | Recruiting |
| Michigan Center of Medical Research | Farmington Hills | Michigan | Recruiting |
| Westchester Putnam Gastroenterology | Carmel | New York | Recruiting |
| New York Gastroenterology Associates | New York | New York | Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| Charlotte Gastroenterology and Hepatology, PLLC | Charlotte | North Carolina | Recruiting |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | Recruiting |
| Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | Recruiting |
| Frontier Clinical Research | Uniontown | Pennsylvania | Recruiting |
| Palmetto Primary and Specialty Care Physicians, Charleston | Summerville | South Carolina | Recruiting |
| DFW Clinical Trials | Carrollton | Texas | Recruiting |
| UT Southwestern | Dallas | Texas | Suspended |
| Lubbock Gastroenterology | Lubbock | Texas | Recruiting |
| Gastroenterology Research of America, LLC | San Antonio | Texas | Recruiting |
| Southern Star Research Institute, LLC | San Antonio | Texas | Recruiting |
| The University of Texas Health Science Center at Tyler | Tyler | Texas | Recruiting |
| LKH-Univ. Klinikum Graz | Graz | Austria | Recruiting |
+ 121 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Denmark
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07499232 on ClinicalTrials.gov ↗ ← All trials in Denmark