Back to resultsA Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC)
Primary Purpose
Colitis, Ulcerative
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JNJ-77242113
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative
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
Sites / Locations
- I.H.S. Health. LLCRecruiting
- Cotton O'Neil Digestive Health CenterRecruiting
- Digestive Disease Specialists IncRecruiting
- Southern Star Research Institute, LLCRecruiting
- Tyler Research Institute, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1: JNJ-77242113 Dose-1
Group 2: JNJ-77242113 Dose-2
Group 3: JNJ-77242113 Dose-3
Group 4: Placebo
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Percentage of Participants with Endoscopic Improvement at 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
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)
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.
Full Information
NCT ID
NCT06049017
First Posted
September 15, 2023
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT06049017
Brief Title
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
Acronym
ANTHEM-UC
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Actual)
Primary Completion Date
May 27, 2025 (Anticipated)
Study Completion Date
October 6, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: JNJ-77242113 Dose-1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: JNJ-77242113 Dose-2
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3: JNJ-77242113 Dose-3
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 4: Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JNJ-77242113
Intervention Description
JNJ-77242113 tablet will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet will be administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants with Clinical Response at Week 12
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Participants with Clinical Remission at Week 12
Description
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
Title
Percentage of Participants with Symptomatic Remission at Week 12
Description
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
Title
Percentage of Participants with Endoscopic Improvement at Week 12
Description
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Time Frame
Week 12
Title
Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12
Description
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
Title
Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)
Description
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.
Time Frame
Up to Week 76
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
I.H.S. Health. LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Cotton O'Neil Digestive Health Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Disease Specialists Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Star Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
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