A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis

Study Overview
=================
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.

Official Title
-----------------
A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis

Conditions
-----------------
Colitis, Ulcerative

Intervention / Treatment
-----------------
* Drug: JNJ-77242113
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: JNJ-77242113 Dose-1<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>|
| Experimental: Group 2: JNJ-77242113 Dose-2<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>|
| Experimental: Group 3: JNJ-77242113 Dose-3<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>|
| Experimental: Group 4: Placebo<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>Drug: Placebo<br>* Placebo tablet will be administered orally.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Week 12 | 
| Percentage of Participants with Endoscopic Improvement at Week 12 | Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. | 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. | 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. | Up to Week 76 |