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A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Crohn Disease

Interventions: Guselkumab, Risankizumab

Countries: United States, Austria, Belgium, Canada, China, Czechia, Denmark, France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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:

  1. a minimum score of 1 for the component of "size of ulcers" AND
  2. 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

Locations (144)

Dothan, Alabama, United States
Mobile, Alabama, United States
Anaheim, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Hamden, Connecticut, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Topeka, Kansas, United States
Lafayette, Louisiana, United States
Farmington Hills, Michigan, United States
Carmel, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Mentor, Ohio, United States
Oklahoma City, Oklahoma, United States
Uniontown, Pennsylvania, United States
Summerville, South Carolina, United States
Carrollton, Texas, United States
Lubbock, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
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