Colitis, Ulcerative
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
Interventions
DRUGJNJ-77242113
JNJ-77242113 tablet will be administered orally.
DRUGPlacebo
Placebo tablet will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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 | Description |
|---|---|---|
| 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 | Description |
|---|---|---|
| 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 | 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. |
| 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, Malaysia, Poland, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed