Tulisokibart for Crohn's Disease

Recruiting at 46 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerance of tulisokibart, a medicine for moderate to severe Crohn's disease and ulcerative colitis. Participants will receive either low or high doses of tulisokibart; some will know their dose, while others will not. The trial seeks individuals who have previously taken tulisokibart in an earlier study and experienced benefits. Participants should not have discontinued tulisokibart early in the previous study and should not have experienced any severe reactions to it. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that tulisokibart is likely to be safe for humans?

Research has shown that tulisokibart is generally safe for people with Crohn's disease. In earlier studies, patients reported taking the medication without serious problems, experiencing no major side effects. This treatment targets those with moderate to severe Crohn's disease, and current evidence suggests it is safe to use. Although the trial is in an advanced stage, earlier results indicate that tulisokibart is likely safe for long-term use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

Tulisokibart is unique because it offers a new approach for treating Crohn's disease. Unlike current standard treatments like biologics and immunosuppressants, which often target inflammation broadly, tulisokibart may work by specifically modulating certain immune pathways with its innovative mechanism. This treatment is delivered subcutaneously, which can provide a more convenient and potentially less invasive option compared to intravenous therapies. Researchers are excited because tulisokibart might offer improved symptom control and a better side effect profile, paving the way for more personalized and effective management of Crohn's disease.

What evidence suggests that tulisokibart might be an effective treatment for Crohn's disease?

Studies have shown that tulisokibart may help treat moderate to severe Crohn's disease. In an early study, patients who took tulisokibart had better results than those who took a placebo, a pill with no active medicine. Specifically, 26% of patients taking tulisokibart went into clinical remission, compared to only 1% of those taking the placebo. This treatment targets certain proteins that cause inflammation. Early findings suggest that tulisokibart is not only effective but also well tolerated by patients.

In this trial, participants will receive different doses of tulisokibart, either low or high, in both blinded and unblinded groups, to further evaluate its effectiveness and safety. ^{1 2 6 7 8}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 ... Tulisokibart is now being evaluated in two Phase 3 studies in ulcerative colitis and Crohn's disease. 12-week data from the Phase 2 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40456235/

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 tolerated.

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06651281

NCT06651281 | Extension Study of Long-term Safety and ... 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 ...

5. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2314076

Phase 2 Trial of Anti-TL1A Monoclonal Antibody ... A significantly higher percentage of patients who received tulisokibart had clinical remission than those who received placebo (26% vs. 1%; ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06430801

NCT06430801 | A Study to Evaluate the Efficacy and ... The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468125325000718

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 tolerated.

8. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/MK-7240-011-00

Long-term Safety and Efficacy of Tulisokibart in Crohn's ... The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called tulisokibart (MK-7240) compared with placebo.