MK-7240 for Ulcerative Colitis

Recruiting at 579 trial locations

Overseen By Irving Cassidy

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Crohn's disease, Fulminant colitis, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1020 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called MK-7240 to determine if it can help individuals with moderately to severely active ulcerative colitis achieve remission, meaning a reduction or disappearance of symptoms. The trial includes different groups testing various doses of the treatment, with some participants receiving a placebo for comparison. Ideal participants have experienced ulcerative colitis symptoms for at least three months and have had insufficient results or side effects from other treatments. As a Phase 3 trial, this is the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it mentions that participants must be on treatment with any protocol-specified drugs and meet drug stabilization requirements. It's best to discuss your current medications with the trial team to understand any specific requirements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tulisokibart has generally been well-tolerated in past studies. Earlier research found it more effective than a placebo in helping patients with moderate to severe ulcerative colitis achieve clinical remission, meaning it reduced symptoms better than no treatment.

Although specific side effects from these studies aren't detailed in the sources, the advanced stage of testing suggests it is considered safe enough for further study. Treatments typically don't reach this stage if major safety concerns exist. Additionally, ongoing studies are examining its long-term safety, indicating careful monitoring for any negative effects.

Overall, tulisokibart appears to have a promising safety profile, but participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about MK-7240 for ulcerative colitis because it offers a potentially unique approach compared to existing treatments like mesalamine, corticosteroids, and biologics such as infliximab. Unlike these standard treatments, MK-7240 utilizes tulisokibart, which provides both intravenous and subcutaneous options, allowing for more flexible dosing regimens. This dual delivery method could optimize the drug's effectiveness and patient convenience. Additionally, tulisokibart might target the inflammatory pathways in a novel way, potentially leading to improved outcomes for patients with ulcerative colitis.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

Research has shown that tulisokibart, the investigational treatment in this trial, can help treat ulcerative colitis. Participants may receive different doses of tulisokibart or a placebo. After 12 weeks, patients taking tulisokibart showed better results than those on a placebo, with more patients experiencing clinical remission, meaning their symptoms improved significantly. The treatment targets TL1A, a protein that causes inflammation, which helps reduce symptoms in the gut. Early results from studies on other conditions like Crohn's disease also suggest tulisokibart may help manage inflammation. Overall, tulisokibart shows promise for people with active ulcerative colitis. ^{1 2 3 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Protocol specified corticosteroid dependence

My ulcerative colitis hasn't improved with one or more treatments.

Satisfies at least 1 of the following criteria:

Exclusion Criteria

I am infected with HBV, HCV, or HIV.

I had shingles or CMV that cleared up less than 8 weeks ago.

I have a transplanted organ and need medicine to suppress my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive either low or high dose IV tulisokibart or placebo for induction treatment

12 weeks

Maintenance Treatment

Participants continue with low or high dose SC tulisokibart regimen for maintenance

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may opt into continuation of treatment with low or high dose SC tulisokibart

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• MK-7240

Trial Overview 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.

How Is the Trial Designed?

Group I: Study 2: Low Dose Induction Experimental Treatment 1 Intervention

Participants receive low dose IV tulisokibart.

Group II: Study 2: Low Dose Extension Experimental Treatment 2 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 Induction Experimental Treatment 1 Intervention

Participants receive high dose IV tulisokibart.

Group IV: Study 2: High Dose Extension Experimental Treatment 1 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 Maintenance Experimental Treatment 3 Interventions

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

Group VI: Study 1: Low Dose Extension Experimental Treatment 2 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 Maintenance Experimental Treatment 3 Interventions

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

Group VIII: Study 1: High Dose Induction, High Dose Maintenance Experimental Treatment 2 Interventions

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

Group IX: Study 1: High Dose Extension Experimental Treatment 1 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: Placebo Placebo Group 3 Interventions

Participants receive IV placebo.

Group XI: Study 1: Placebo Placebo Group 3 Interventions

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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

PPD, Part of Thermo Fisher Scientific

Industry Sponsor

Trials

3

Recruited

2,100+

Published Research Related to This Trial

Mirikizumab, a monoclonal antibody targeting the IL-23 pathway, has been shown to effectively induce and maintain remission in patients with moderately to severely active ulcerative colitis, including those who previously did not respond to other treatments.

This therapy has a favorable safety profile and is the first IL-23 antagonist to receive regulatory approval for ulcerative colitis in Europe, addressing a significant need for new treatment options in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirikizumab for the treatment of moderate to severe ulcerative colitis. Hanzel, J., Ma, C., Jairath, V.[2023]

Anti-IL-23 agents, such as mirikizumab and ustekinumab, have shown significant efficacy in treating ulcerative colitis (UC) in clinical trials, achieving both clinical and endoscopic improvements with a favorable safety profile.

Ongoing trials are exploring the effectiveness of various anti-IL-23 agents compared to existing treatments and investigating the potential for combination therapies, which could enhance treatment strategies for UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-interleukin-23 agents for the treatment of ulcerative colitis. Hanžel, J., D'Haens, GR.[2020]

In two Phase 3 trials involving 1162 patients for induction and 544 for maintenance, mirikizumab significantly improved bowel urgency in ulcerative colitis patients compared to placebo, with higher rates of clinically meaningful improvement and remission at both 12 and 52 weeks.

Patients who experienced improvement in bowel urgency while on mirikizumab also showed better overall clinical outcomes, including higher rates of clinical remission and improved quality of life, indicating that addressing bowel urgency can enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. Dubinsky, MC., Clemow, DB., Hunter Gibble, T., et al.[2023]

A 52-year-old woman with a long history of left-sided chronic ulcerative colitis experienced a successful treatment with ustekinumab after failing multiple standard therapies, including mesalamine and biologics.

This case report is significant as it demonstrates the rapid induction and maintenance of remission in a patient with active refractory ulcerative colitis using ustekinumab, marking the first documented use of this medication for this condition, resulting in over one year of complete remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Induction and Maintenance of Remission in Refractory Ulcerative Colitis with Ustekinumab. Chen, AY., Oz, HS.[2020]

Tofacitinib is a new oral medication that works by inhibiting Janus kinases, which are important in the inflammation process of ulcerative colitis (UC), and has been approved by the FDA and EMA for treating moderate-to-severe UC.

Clinical trials (Phase II and III) have shown that tofacitinib is effective in inducing and maintaining remission in UC, especially for patients who do not respond to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of Tofacitinib in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Recent Data. Varyani, F., Argyriou, K., Phillips, F., et al.[2023]

Citations

1. merck.com merck.com/news/merck-to-present-new-long-term-data-for-tulisokibart-mk-7240-an-investigational-anti-tl1a-monoclonal-antibody-in-inflammatory-bowel-disease-at-ueg-week-2024/

Merck to Present New Long-Term Data for Tulisokibart ... Findings published in the New England Journal of Medicine show that after 12 weeks, tulisokibart was more effective than placebo for inducing ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06052059

NCT06052059 | A Study to Evaluate Efficacy and Safety of ... A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001).

3. gut.bmj.com gut.bmj.com/content/74/Suppl_1/A10

the open-label extension of the phase 2 ARTEMIS-UC study Efficacy and safety of approximately 3 years of continuous ozanimod in moderately to severely active ulcerative colitis: interim analysis of the True North open ...

4. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(25)00071-8/abstract

Safety and efficacy of the anti-TL1A monoclonal antibody ... This proof-of-concept study showed that tulisokibart is potentially efficacious in moderately to severely active Crohn's disease and is well ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39321363/

Phase 2 Trial of Anti-TL1A Monoclonal Antibody ... In this short-term trial, tulisokibart was more effective than placebo in inducing clinical remission in patients with moderately to severely active ulcerative ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06651281

NCT06651281 | Extension Study of Long-term Safety and ... Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) · Study Overview.