Tulisokibart for Crohn's Disease

Recruiting at 20 trial locations

Overseen By Toll Free Number

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Discontinued parent study, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Duration: 364 weeks

1380 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Tulisokibart for Crohn's Disease?

The research mentions that drugs like ustekinumab, which blocks certain proteins involved in inflammation, have been effective in treating Crohn's disease, especially for patients who did not respond to other treatments. This suggests that similar mechanisms in Tulisokibart could potentially be effective as well. ^{1 2 3 4 5}

What is the purpose of this trial?

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for people who have moderate to severe Crohn's disease or ulcerative colitis and were part of earlier tulisokibart studies. They must be seeing benefits from the treatment, not pregnant or breastfeeding, and if they can get pregnant, they need to use birth control or practice abstinence.

Inclusion Criteria

I was part of a Phase 2 or 3 study for Crohn's disease or ulcerative colitis.

My doctor thinks I benefit from the ongoing treatment based on past study results.

I am not pregnant and have a recent negative pregnancy test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low or high dose of tulisokibart, administered subcutaneously, in an unblinded or blinded manner

364 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

Open-label extension

Participants may continue to receive tulisokibart to evaluate long-term safety and efficacy

Long-term

Treatment Details

Interventions

• Tulisokibart

Trial Overview The study is testing the long-term safety and effectiveness of a drug called tulisokibart in patients with Crohn's disease or ulcerative colitis. Participants are those who've taken it before in previous phases of research.

Participant Groups

Group I: Group 4: Low Dose Blinded Experimental Treatment 2 Interventions

Participants receive a blinded low dose SC tulisokibart regimen.

Group II: Group 3: High Dose Blinded Experimental Treatment 1 Intervention

Participants receive a blinded high dose SC tulisokibart regimen.

Group III: Group 2: High Dose Unblinded Experimental Treatment 1 Intervention

Participants receive a high dose SC tulisokibart regimen.

Group IV: Group 1: Low Dose Unblinded Experimental Treatment 1 Intervention

Participants receive a low dose subcutaneous (SC) tulisokibart 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

Findings from Research

In a comparison of risankizumab (RZB) and ustekinumab (UST) for treating Crohn's disease, RZB showed significantly higher rates of clinical and endoscopic improvement during the induction phase, with 15% more patients achieving CDAI remission and 26% more showing endoscopic response.

After the maintenance phase, the rates of CDAI remission were similar between RZB and UST, but RZB still demonstrated better endoscopic response and remission rates, indicating that while both treatments are effective, RZB may offer advantages during initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Dubinsky, M., Ma, C., Griffith, J., et al.[2023]

In a long-term study of 107 patients with Crohn's disease, upadacitinib demonstrated sustained clinical remission rates of around 54-61% over 30 months, indicating its efficacy as a treatment.

While upadacitinib showed long-term benefits, the safety profile revealed that higher doses (30 mg) were associated with increased rates of adverse events compared to lower doses (15 mg), consistent with its known safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. D'Haens, G., Panés, J., Louis, E., et al.[2022]

Vedolizumab is a safe and effective gut-specific biological agent for long-term treatment of Crohn's disease and ulcerative colitis, particularly in patients who have not responded to anti-TNF therapies.

Tofacitinib, an oral JAK inhibitor, shows promise for achieving remission in moderately to severely active ulcerative colitis, although its effectiveness in Crohn's disease is less certain, highlighting the need for careful monitoring of safety risks like infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Emerging Therapies: What Are Promising in the Near Future?] Seo, GS., Lee, SH.[2018]

Recent advancements in treating Crohn's disease and ulcerative colitis include new drugs that target specific immune pathways, such as natalizumab and vedolizumab, which disrupt lymphocyte movement to the gut.

Ustekinumab and tofacitinib represent innovative therapies that block key cytokines involved in inflammation, showing promise in clinical trials for improving outcomes in patients with inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments in the treatment of inflammatory bowel disease. Rietdijk, ST., D'Haens, GR.[2018]

Risankizumab, an IL-23 p19 inhibitor, demonstrated significant efficacy in inducing clinical remission and endoscopic response in patients with moderately to severely active Crohn's disease, with remission rates of up to 45% compared to 25% in the placebo group in the ADVANCE trial.

The treatment was well tolerated, with a similar incidence of adverse events across all groups, and the one death in the risankizumab group was determined to be unrelated to the drug, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. D'Haens, G., Panaccione, R., Baert, F., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

[Emerging Therapies: What Are Promising in the Near Future?] [2018]

4. Australia pubmed.ncbi.nlm.nih.gov

Recent developments in the treatment of inflammatory bowel disease. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. [2022]