ANTHEM-UC: A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: JNJ-77242113 Dose-1 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
JNJ-77242113 tablet will be administered orally.
|
| Experimental: Group 2: JNJ-77242113 Dose-2 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
JNJ-77242113 tablet will be administered orally.
|
| Experimental: Group 3: JNJ-77242113 Dose-3 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
JNJ-77242113 tablet will be administered orally.
|
| Experimental: Group 4: 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. |
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally.
Drug: Placebo
Placebo tablet will be administered orally.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed informed consent form 18 years of age or older
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Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
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Moderately to severely active UC as per the modified Mayo score
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Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Exclusion Criteria:
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Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
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UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon
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Presence of a stoma
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Presence or history of fistula
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History of extensive colonic resection (example, <30 cm of colon remaining)
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Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 77242113UCO2001
- 77242113UCO2001