Colitis, Ulcerative
Conditions
Interventions
JNJ-77242113: JNJ-77242113 tablet will be administered orally.
Group 1: Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28.
Group 2: Participants will receive J
Sponsors
Kano Yuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent form 18 years of age or older - Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening - Moderately to severely active UC as per the modified Mayo score - Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Exclusion criteria
Exclusion criteria: " - Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon - UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon - Presence of a stoma - Presence or history of fistula - History of extensive colonic resection (example, <30 cm of colon remaining) - Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Clinical Response at Week 12 Week 12 Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of Participants with Clinical Remission at Week 12 - Week 12 Clinical remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. - Percentage of Participants with Symptomatic Remission at Week 12 - Week 12 Symptomatic remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, and a rectal bleeding subscore of 0. - Percentage of Participants with Endoscopic Improvement at Week 12 - Week 12 Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. - Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12 - Week12 Histologic-endoscopic mucosal improvement is defined as a combination of histologic remission and endoscopic improvement. Histologic remission and endoscopic improvement are based on the histologic grading and the Mayo endoscopy subscore. - Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs) - Up to Week 76 An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A 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; is medically important. | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hungary, India, Italy, Japan, Korea Republic Of, Malaysia, Poland, Romania, Spain, Turkiye, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed