What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include mesalamine, glucocorticoids, and biologics. Mesalamine can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids, like prednisone, are associated with side effects including weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Biologics, such as anti-TNF agents, can lead to infections, infusion reactions, and potential development of antibodies against the medication. Patients should discuss these potential side effects with their healthcare provider to make an informed decision about their treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Ulcerative Colitis, including anti-TNF agents like infliximab (Remicade) and adalimumab (Humira), which help reduce inflammation by inhibiting tumor necrosis factor-alpha. Integrin receptor antagonists such as vedolizumab (Entyvio) prevent inflammatory cells from entering the gut. Additionally, interleukin inhibitors like ustekinumab (Stelara) target specific proteins involved in the inflammatory process. These treatments are similar to the investigational drug Tulisokibart, which is being studied for its efficacy and safety in patients with moderately to severely active Ulcerative Colitis.

What other types of research exist?

Promising novel alternatives to Tulisokibart for Ulcerative Colitis patients in 2024 include anti-IL-23 therapies, JAK-inhibitors, anti-integrins, and S1P modulators. These therapies are currently in phase 3 clinical trials and have demonstrated efficacy and safety in treating UC.

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Monoclonal Antibodies

MK-7240 for Ulcerative Colitis

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 and week 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing tulisokibart, a new medication, to see if it can help people with moderately to severely active ulcerative colitis. The goal is to determine if tulisokibart can reduce inflammation and heal sores in the colon, leading to fewer symptoms. The study will compare different doses of tulisokibart over several months.

Who is the study for?

This trial is for people with moderate to severe ulcerative colitis who've had symptoms for at least 3 months, weigh over 40 kg, and haven't responded well to certain treatments. Participants must be adults or adolescents approved by local authorities, use contraception if they can have children, and not be pregnant or breastfeeding.

What is being tested?

The study tests Tulisokibart's effectiveness in achieving clinical remission of ulcerative colitis at weeks 12 and 52 compared to a placebo. It involves two forms of administration: subcutaneous (SC) injections and intravenous (IV) infusions.

What are the potential side effects?

While the specific side effects are not listed here, participants should expect potential risks associated with immune-modulating therapies like infections, infusion reactions, possible organ inflammation, allergic responses or worsening of their condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52

Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12

Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE

+4 more

Secondary study objectives

Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12

Percentage of Dx+ Participants With Endoscopic Improvement at Week 12

Study 1: Change from Baseline in FACIT-Fatigue Score at Week 52

+36 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

11Treatment groups

Experimental Treatment

Placebo Group

Group I: Study 2: Low Dose InductionExperimental Treatment1 Intervention

Participants receive low dose IV tulisokibart.

Group II: Study 2: Low Dose ExtensionExperimental Treatment2 Interventions

Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Group III: Study 2: High Dose InductionExperimental Treatment1 Intervention

Participants receive high dose IV tulisokibart.

Group IV: Study 2: High Dose ExtensionExperimental Treatment1 Intervention

Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Group V: Study 1: Low Dose Induction, Low Dose MaintenanceExperimental Treatment3 Interventions

Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

Group VI: Study 1: Low Dose ExtensionExperimental Treatment2 Interventions

Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

Group VII: Study 1: High Dose Induction, Low Dose MaintenanceExperimental Treatment3 Interventions

Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

Group VIII: Study 1: High Dose Induction, High Dose MaintenanceExperimental Treatment2 Interventions

Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.

Group IX: Study 1: High Dose ExtensionExperimental Treatment1 Intervention

Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

Group X: Study 2: PlaceboPlacebo Group3 Interventions

Participants receive IV placebo.

Group XI: Study 1: PlaceboPlacebo Group3 Interventions

Participants receive IV placebo, followed by an SC placebo regimen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SC Placebo

2011

Completed Phase 4

~1290

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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 aminosalicylates, corticosteroids, immunomodulators, and biologics. Aminosalicylates, like mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory chemicals. Corticosteroids, such as prednisone, suppress the immune system to decrease inflammation rapidly. Immunomodulators, including azathioprine, alter the immune response to prevent ongoing inflammation. Biologics, like infliximab, target specific proteins involved in the inflammatory process, such as tumor necrosis factor (TNF), to reduce inflammation and promote healing. These treatments are crucial for UC patients as they help manage symptoms, induce and maintain remission, and improve quality of life by controlling the chronic inflammation characteristic of the disease.

Novel topical therapies for distal colitis.