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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
530
Guselkumab will be administered.
Risankizumab will be administered.
Number of Participants with Deep Remission 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.
Time frame: At Week 52
Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52
Clinical remission is defined as CDAI score \< 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 response is defined as \>50 percent (%) improvement from baseline in the SES CD or SES-CD score \<= 2 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response.
Time frame: At Week 52
Number of Participants with Endoscopic Remission at Week 52
Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \> 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At Week 52
Number of Participants with Clinical Remission at Week 52
Clinical remission is defined as CDAI score \< 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.
Time frame: At Week 52
Number of Participants with Steroid-Free Clinical Remission at Week 52
Steroid-free clinical remission is defined as clinical remission at Week 52 and not receiving corticosteroids for at least 90 days prior to Week 52. Clinical remission is defined as CDAI score \< 150-point.
Time frame: At Week 52
Number of Participants with Abnormalities in Laboratory Parameters
Number of participants with abnormalities in laboratory parameters (hematology and chemistry) will be reported.
Time frame: Up to Week 148
Number of Participants With Change From Baseline in Laboratory Abnormalities
Number of participants with change from baseline in laboratory abnormalities (hematology and chemistry) will be reported.
Time frame: Up to week 148
Number of Participants with Adverse Events (AEs), Serious AEs and AEs Leading to Discontinuation of Study Intervention
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Time frame: Up to Week 165