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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

Study Summary

This trial will evaluate if MK-7240 is safe and effective for treating ulcerative colitis, with primary hypotheses evaluated at 12 and 52 weeks.

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.Check my eligibility
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.See study design
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 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

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

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. Participants who meet protocol-specified conditions may later enter either the Study 2: High Dose Extension arm or Study 2: Low Dose Extension arm.
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

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.

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Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,910 Previous Clinical Trials
5,065,409 Total Patients Enrolled
15 Trials studying Ulcerative Colitis
3,757 Patients Enrolled for Ulcerative Colitis
PPD, Part of Thermo Fisher ScientificIndustry Sponsor
2 Previous Clinical Trials
1,080 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,792 Previous Clinical Trials
8,067,419 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
3,856 Patients Enrolled for Ulcerative Colitis
~680 spots leftby Nov 2026