MK-7240 for Ulcerative Colitis

Recruiting at 445 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

Trial Summary

What is the purpose of this trial?

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.

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.

What evidence supports the effectiveness of the drug MK-7240 for treating ulcerative colitis?

Research on similar drugs, like mirikizumab and ustekinumab, which target the IL-23 pathway, shows they can help control symptoms and maintain remission in ulcerative colitis. These drugs have been effective in patients who did not respond to other treatments, suggesting that MK-7240 might also be beneficial. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

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

Protocol specified corticosteroid dependence

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mirikizumab for the treatment of moderate to severe ulcerative colitis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Anti-interleukin-23 agents for the treatment of ulcerative colitis. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Rapid Induction and Maintenance of Remission in Refractory Ulcerative Colitis with Ustekinumab. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Profile of Tofacitinib in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Recent Data. [2023]

5. England 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. [2023]