Guselkumab
DrugGuselkumab will be administered.
Other names: CNTO1959
NCT Number: NCT07499232
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Medizinische Universitatsklinik Innsbruck, Innsbruck, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Guselkumab will be administered.
Other names: CNTO1959
Risankizumab will be administered.
Time frame: 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
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
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.
Time frame: 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
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: Up to Week 148
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 (hematology and chemistry) will be reported.
Time frame: Up to Week 165
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.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
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
Acronym: CHARGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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