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

Recruiting in Palo Alto (17 mi)

+191 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

My condition did not improve with standard treatments, or I couldn't tolerate them.

I have been diagnosed with ulcerative colitis for at least 3 months.

+1 more

Exclusion Criteria

I have or had severe colitis or toxic megacolon.

I have a stoma.

My ulcerative colitis affects only my rectum or less than 15 cm of my colon.

+3 more

Participant Groups

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.

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.