What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include sulfasalazine, mesalamine, glucocorticoids, and immunomodulators like PF-00547659. Sulfasalazine can cause side effects such as rash, fever, and gastrointestinal discomfort. Mesalamine is generally well-tolerated but may cause headaches, nausea, and abdominal pain. Glucocorticoids are effective for short-term use but can lead to systemic side effects like adrenal suppression, weight gain, and increased infection risk. PF-00547659 has been shown to be safe and well-tolerated, with better outcomes than placebo in inducing remission. Patients should discuss these options and their potential side effects with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, focusing on immunomodulators and anti-inflammatory agents. Key drugs include 5-aminosalicylates like mesalamine and sulfasalazine, which reduce inflammation in the colon. Corticosteroids such as prednisone are used for their potent anti-inflammatory effects. Immunosuppressives like azathioprine and 6-mercaptopurine help control the immune response. Biologics, including anti-TNF agents like infliximab and adalimumab, target specific components of the immune system to reduce inflammation. These treatments aim to induce and maintain remission in patients with UC.

What other types of research exist?

Promising alternatives to JNJ-77242113 for Ulcerative Colitis patients include: 1) Infliximab, which has shown long-term benefits in preventing endoscopic recurrence in Crohn's disease and is effective in UC. 2) Adalimumab, effective in preventing clinical and endoscopic recurrence in Crohn's disease and used in UC. 3) Vedolizumab, which has demonstrated efficacy in UC and Crohn's disease. 4) Ustekinumab, effective in other inflammatory conditions and used in UC. These agents have robust clinical data supporting their use in inflammatory bowel diseases.

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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

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

Select...

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.

Select...

I have had a major part of my colon removed.

Select...

I have or had a fistula.

Select...

I have been diagnosed with a specific type of colitis or have symptoms of Crohn's disease.

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

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

0 / 7Eligibility criteria met

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.