A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Recruiting · NCT07499232 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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:
- a minimum score of 1 for the component of "size of ulcers" AND
- a minimum score of 1 for the component of "ulcerated surface"
- 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
- Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
- Currently has or is suspected to have an abscess
- Has an active fistula during screening or at Week 0 with an anticipated need for surgery
- Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention
- Currently has a malignancy or has a history of malignancy within 5 years before screening
Where it is running
60 locations listed across 19 US states.
- Digestive Health Specialists of the Southeast - Dothan, Alabama, United States
- East View Medical Research - Mobile, Alabama, United States
- Clinnova Research - Anaheim, California, United States
- Gastro Care Institute - Lancaster, California, United States
- United Gastroenterologists - Los Alamitos, California, United States
- TLC Clinical Research Inc - Los Angeles, California, United States
- GastroIntestinal Bioscience - Los Angeles, California, United States
- Hoag Memorial Hospital - Newport Beach, California, United States
- Medical Associates Research Group, Inc. - San Diego, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Medical Research Center of Connecticut - Hamden, Connecticut, United States
- Green Leaf Clinical Trials - Jacksonville, Florida, United States
- Sanchez Clinical Research, Inc - Miami, Florida, United States
- Biodax Medical Research Trials - Miami, Florida, United States
- GI Pros Research - Naples, Florida, United States
- GCP Clinical Research - Tampa, Florida, United States
- Morehouse School of Medicine - Atlanta, Georgia, United States
- Atlanta Gastroenterology Associates - Atlanta, Georgia, United States
- Gastroenterology Associates of Central GA - Macon, Georgia, United States
- Comprehensive Gastrointestinal Health Libertyville - Northbrook, Illinois, United States
- Cotton-O'Neil Clinical Research Center - Topeka, Kansas, United States
- Gastroenterology Clinic of Acadiana - Lafayette, Louisiana, United States
- Woodholme Gastroenterology Associates - Glen Burnie, Maryland, United States
- Lucida Clinical Trials - New Bedford, Massachusetts, United States
- Michigan Center of Medical Research - Farmington Hills, Michigan, United States
- Westchester Putnam Gastroenterology - Carmel, New York, United States
- New York Gastroenterology Associates - New York, New York, United States
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- Charlotte Gastroenterology and Hepatology, PLLC - Charlotte, North Carolina, United States
- Great Lakes Gastroenterology Research, LLC - Mentor, Ohio, United States
- Digestive Disease Specialists Inc - Oklahoma City, Oklahoma, United States
- Frontier Clinical Research - Uniontown, Pennsylvania, United States
- Palmetto Primary and Specialty Care Physicians, Charleston - Summerville, South Carolina, United States
- DFW Clinical Trials - Carrollton, Texas, United States
- UT Southwestern - Dallas, Texas, United States
- Lubbock Gastroenterology - Lubbock, Texas, United States
- Gastroenterology Research of America, LLC - San Antonio, Texas, United States
- Southern Star Research Institute, LLC - San Antonio, Texas, United States
- The University of Texas Health Science Center at Tyler - Tyler, Texas, United States
- Aarhus University Hospital - Aarhus C, Denmark
- Hosp. Gral. Univ. Dr. Balmis - Alicante, Spain
- CHU Amiens Picardie - Amiens, France
- FNsP F. D. Roosevelta Banska Bystrica - Banská Bystrica, Slovakia
- Hosp. Clinic de Barcelona - Barcelona, Spain
- GASTRO-Studien - Berlin, Germany
- Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF) - Berlin, Germany
- A O U Sant Orsola Malpighi - Bologna, Italy
- Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano - Bolzano, Italy
- Cliniq s.r.o. - Bratislava, Slovakia
- Fakultni nemocnice Brno - Brno, Czechia
- Vojenska nemocnice Brno - Brno, Czechia
- ULB Erasme Ziekenhuis - Brussels, Belgium
- Cliniques Universitaires Saint Luc - Brussels, Belgium
- Obudai Egeszsegugyi Centrum Kft - Budapest, Hungary
- Semmelweis Egyetem 1 - Budapest, Hungary
- Semmelweis Egyetem 2 - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- Endomedix - Budapest, Hungary
- Pannónia Magánorvosi Centrum Kft - Budapest, Hungary
- Centrum Medyczne Medis ManerMed Sp Z O O - Bydgoszcz, Poland
Showing 60 of 160 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →