A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Colitis, Ulcerative
- Interventions
- Drug: Placebo
- Registration Number
- NCT06049017
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 252
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: JNJ-77242113 Dose-1 JNJ-77242113 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 clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76. Group 2: JNJ-77242113 Dose-2 JNJ-77242113 Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76. Group 3: JNJ-77242113 Dose-3 JNJ-77242113 Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76. Group 4: Placebo Placebo Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76. Group 4: Placebo JNJ-77242113 Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (175)
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
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