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Monoclonal Antibodies

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

Verified Trial
Phase 2
Waitlist Available
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
Must not have
Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
Presence of a stoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 76

Summary

This trial is testing a new medication called JNJ-77242113 to see if it can help people with moderately to severely active ulcerative colitis. The medication aims to reduce inflammation in the colon by calming the immune system. Researchers want to find out if it is safe and effective.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ulcerative colitis is moderate to severe according to the Mayo score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or had severe colitis or toxic megacolon.
Select...
I have a stoma.
Select...
My ulcerative colitis affects only my rectum or less than 15 cm of my colon.
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I have had a major part of my colon removed.
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I have or had a fistula.
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I have been diagnosed with a specific type of colitis or have symptoms of Crohn's disease.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants with Clinical Response at Week 12
Secondary study objectives
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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Ulcerative Colitis (UC) include immunomodulators and anti-inflammatory agents. Immunomodulators, such as azathioprine and 6-mercaptopurine, work by altering the immune system's activity to reduce inflammation and prevent flare-ups. Anti-inflammatory agents, like mesalamine, target the inflammation directly in the colon lining. These treatments are crucial for UC patients as they help maintain remission, reduce symptoms, and improve quality of life by controlling the chronic inflammation characteristic of the disease.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,402,119 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
772 Previous Clinical Trials
3,980,146 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis
~116 spots leftby Dec 2025