Colitis, Ulcerative
Conditions
Sponsors
Sakamoto Takehiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline - Moderately to severely active UC as assessed by the modified Mayo score - Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity - If female and of childbearing potential, must meet the contraception and reproduction requirements
Exclusion criteria
Exclusion criteria: - Has severe extensive colitis as defined in the protocol - Extent of inflammatory disease limited to the rectum - Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD) - Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer - Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Clinical Remission at Week 48 Week 48 Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Endoscopic Improvement at Week 48:Week 48 Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore. Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48 : Week 48 Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported. Percentage of Participants with Symptomatic Remission at Week 48:Week 48 Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms. Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48:Week 48 Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore. Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48:Week 48 Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores will be reported. Percentage of Participants with Adverse Events (AEs):Up to Week 48 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. Percentage of Participants with Serious Adverse Events (SAEs):Up to Week 48 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 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea Republic Of, Netherlands, NewZealand, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Switzerland, Turkiye, United Kingdom Of Great Britain
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed