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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
JNJ-77242113 tablet will be administered orally.
Placebo tablet will be administered orally.
Percentage of Participants with Clinical Response at 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.
Time frame: Week 12
Percentage of Participants with Clinical Remission at 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.
Time frame: Week 12
Percentage of Participants with Symptomatic Remission at 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.
Time frame: Week 12
Percentage of Participants with Endoscopic Improvement at Week 12
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Time frame: Week 12
Percentage of Participants with Histologic-endoscopic Mucosal Improvement at 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.
Time frame: Week 12
Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)
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.
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Clinnova Research
Anaheim, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
I.H.S. Health. LLC
Kissimmee, Florida, United States
Endoscopic Research Inc
Orlando, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastroenterology of Southern Indiana
New Albany, Indiana, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States
...and 167 more locations
Time frame: Up to Week 76