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Monoclonal Antibodies

JNJ-77242113 for Ulcerative Colitis (ANTHEM-UC Trial)

Verified Trial

Phase 2

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderately to severely active UC as per the modified Mayo score

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 76

Awards & highlights

ANTHEM-UC Trial Summary

This trial evaluates a drug to treat ulcerative colitis, testing its safety and effectiveness in people with moderate to severe symptoms.

Who is the study for?

This trial is for adults with ulcerative colitis that's been active for at least 12 weeks and hasn't improved with standard treatments. It's not suitable for those whose condition is limited to the rectum or a short section of the colon, have had significant colon surgery, or have other types of bowel diseases.Check my eligibility

What is being tested?

The study tests JNJ-77242113 against a placebo to see if it's safer and more effective in treating moderately to severely active ulcerative colitis. Participants will be randomly assigned to receive either the drug or placebo.See study design

What are the potential side effects?

Possible side effects of JNJ-77242113 may include typical drug reactions like nausea, headaches, potential allergic responses, and any specific effects related to immune system modulation since it targets inflammation.

ANTHEM-UC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My ulcerative colitis is moderate to severe according to the Mayo score.

ANTHEM-UC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 76

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 76

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 76 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Clinical Response at Week 12

Secondary outcome measures

Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)

Percentage of Participants with Clinical Remission at Week 12

Percentage of Participants with Endoscopic Improvement at Week 12

+2 more

ANTHEM-UC Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4: PlaceboExperimental Treatment2 Interventions

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 II: Group 3: JNJ-77242113 Dose-3Experimental Treatment1 Intervention

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 III: Group 2: JNJ-77242113 Dose-2Experimental Treatment1 Intervention

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 IV: Group 1: JNJ-77242113 Dose-1Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

JNJ-77242113

2022

Completed Phase 2

~640

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,452 Total Patients Enrolled

3 Trials studying Ulcerative Colitis

1,626 Patients Enrolled for Ulcerative Colitis

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,960,038 Total Patients Enrolled

3 Trials studying Ulcerative Colitis

1,626 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What can be concluded about the safety of JNJ-77242113 Dose-1 with respect to individuals?

"Currently, the safety of Group 1: JNJ-77242113 Dose-1 is rated at 2 out of 3 as this trial is classified as a Phase 2 study; where there are some indications that it may be safe but no existing proof of its efficacy."

Answered by AI

How many venues has this clinical experiment been deployed to?

"Patients can access this trial at Cotton O'Neil Digestive Health Center in Topeka, Kansas; Digestive Disease Specialists Inc in Oklahoma City, Oklahoma; as well as Southern Star Research Institute, LLC located in San Antonio Texas. Additionally, there are 5 more sites spread throughout the country."

Answered by AI

How many participants are currently accepted for this clinical investigation?

"Affirmative. According to the data found on clinicaltrials.gov, this trial is recruiting participants as of October 10th 2023 - which followed its initial posting from September 10th 2023. This study needs to find 240 patients at 5 different sites in order to conclude."

Answered by AI

Are there any vacancies remaining in this clinical investigation?

"Affirmative, the study is still actively recruiting patients. According to clinicaltrials.gov, this research project was initially published on October 9th 2023 and has since been revised once as of today's date (October 10th 2023). 240 participants across 5 sites need to be recruited."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06049017.

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