Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: JNJ-77242113 Dose-1: Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinic
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Signed informed consent form 18 years of age or older. Documented diagnosis of ulcerative colitis 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 or advanced therapy as defined in the protocol
Exclusion criteria
Exclusion criteria: Participants with current or prior diagnosis of fulminant colitis and or 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, less than 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 |
|---|---|
| Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to 30 percent and greater than or equal to 2 points, with either a greater than or equal to 1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.Timepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical 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 or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important.Timepoint: Up to Week 76;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.Timepoint: Week 12;Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.Timepoint: Week 12;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.Timepoint: 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.Timepoint: Week 12 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Poland, Republic of Korea, Romania, Spain, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd.
Outcome results
None listed