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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 Achieving Clinical Remission Per MMS at Week 52
Percentage of Dx+ Participants With Endoscopic Improvement at Week 12
+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

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,126 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
2,777 Previous Clinical Trials
8,063,384 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
3,856 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Study 2: Low Dose Extension?

"Our team at Power believes Study 2: Low Dose Extension is comparatively safe, as suggested by its score of 3 on our scale. This assessment was based upon the multiple rounds of data verifying efficacy and safety that were collected during Phase 3 trials."

Answered by AI

Does this experiment have any openings for participants?

"The trial, initially posted on October 18th 2023, is actively seeking participants as seen on clinicaltrials.gov and was recently updated on October 27th of the same year."

Answered by AI

Does this research project permit participants who are 30 years of age or older?

"This trial requires that potential participants are between 16 and 75 years of age. Furthermore, there are 79 separate studies for people below the legal age and 365 specifically targeting seniors over 65 years old."

Answered by AI

What is the maximal number of participants that this trial can accommodate?

"Indeed, according to clinicaltrials.gov, this research is actively recruiting study participants. It was originally posted on October 18th 2023 and has since been updated on the 27th of that same month. This trial requires 1020 individuals at 2 different sites for completion."

Answered by AI

What outcomes are investigators hoping to see from this research?

"This clinical trial will monitor participants over the course of 52 weeks in order to evaluate the percentage of patients who reach remission per MMS at week 12. Additionally, this research project seeks to determine how many people report no abdominal pain or bowel urgency by week 12 (as measured on a 0-4 and 0-11 NRS respectively) as well as quantify those who achieve HER by Week 12 (Geboes score <2 and ES=0/1)."

Answered by AI

To whom is this clinical research available?

"This investigation is seeking 1020 participants aged 16 to 75 with ulcerative colitis. Additionally, these subjects must meet the following criteria: Have had symptoms of UC for at least 3 months prior to screening; Demonstrate moderate-severe active disease; Weigh 40 kilograms or more; Be unresponsive/intolerant to pre-specified treatments and drugs within the study protocol; Corticosteroid dependence in some cases may be necessary; Adolescents between 16 and 18 years of age are deemed suitable as long as they obtain local regulatory approval; Male patients assigned at birth must agree to abstain from sexual intercourse unless use prescribed contraception if"

Answered by AI

Who else is applying?

What site did they apply to?
Digestive Health Specialists ( Site 0135)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
2023. "A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052059.
~680 spots leftby Nov 2026
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