Tulisokibart for Crohn's Disease

Recruiting at 577 trial locations

Overseen By Toll Free Number

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Ulcerative colitis, Short bowel, 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

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called tulisokibart for individuals with Crohn's disease, which inflames the digestive tract. The researchers aim to determine if tulisokibart can help achieve remission, where symptoms significantly improve or disappear. The trial includes various groups testing different doses to find the most effective option. Suitable candidates have had Crohn's for at least three months and have not responded to other treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking 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 might be best to discuss this with the trial coordinators or your doctor.

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

Research has shown that tulisokibart is well-tolerated by people with moderate to severe Crohn's disease. In earlier studies, patients using tulisokibart experienced no major side effects, indicating its safety. Further testing aims to confirm these results.

Tulisokibart is also under study for ulcerative colitis, suggesting confidence in its safety. As a Phase 3 study, tulisokibart has undergone previous human testing, which demonstrated general safety. However, side effects can occur, so discussing personalized advice with a doctor is important. ^{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 to treating Crohn's disease by using a potentially more effective dosing strategy. Unlike many current treatments, which often involve oral medications like mesalamine or biologics such as infliximab, tulisokibart is administered intravenously and subcutaneously, allowing for precise control over dosage levels. Researchers are excited about tulisokibart because it targets the disease with high and low dose regimens, potentially leading to quicker and more sustained remission for patients. This flexibility in dosing might offer better management of symptoms and improved quality of life for those with Crohn's disease.

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

Research has shown that tulisokibart might help treat Crohn's disease. In an earlier study, 26% of patients taking tulisokibart went into remission, meaning their symptoms improved significantly, compared to only 1% of those who took a placebo, a harmless pill with no active medicine. In this trial, participants will be assigned to different treatment arms, including high-dose and low-dose regimens of tulisokibart, as well as placebo arms. Tulisokibart has also shown promise for ulcerative colitis, another type of inflammatory bowel disease, where it outperformed a placebo. This treatment targets a protein called TL1A, which is involved in causing inflammation, helping to reduce symptoms. Early findings suggest it is generally well-tolerated and could provide relief for people with Crohn’s disease. ^{1 3 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 with moderate to severe Crohn's Disease. Participants should have active symptoms and be willing to receive either an IV or SC injection of the study drug or placebo. Specific details on who can join are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

My Crohn's disease is moderate to severe.

I was diagnosed with Crohn's disease over 3 months ago.

I have not responded well to steroids, immunomodulators, or advanced therapies.

Exclusion Criteria

I have or might have COVID-19.

I have previously been treated with tulisokibart or a similar medication.

I have been diagnosed with ulcerative colitis or indeterminate colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

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

12 weeks

Maintenance Treatment

Participants receive high or low dose SC tulisokibart or placebo for maintenance treatment

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue in a high or low dose SC tulisokibart regimen if they meet protocol-specific prerequisites

What Are the Treatments Tested in This Trial?

Interventions

• Tulisokibart

Trial Overview The trial is testing Tulisokibart, given through IV or SC injections, against a placebo to see if it helps achieve clinical remission and endoscopic response in Crohn's Disease patients at weeks 12 and 52.

How Is the Trial Designed?

Group I: Study 2: Low Dose Induction Experimental Treatment 3 Interventions

Participants receive low dose IV tulisokibart.

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

Participants receive a low dose SC tulisokibart regimen. Participants may continue 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 2 Interventions

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 continue 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 continue 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 continue 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

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. 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.

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

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%; ...

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

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04996797

NCT04996797 | A Phase 2 Safety and Efficacy Study of ... The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC).

5. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/tulisokibart-efficacy-clinical-remission-ulcerative-colitis-patients

Tulisokibart Shows Superior Efficacy in Achieving ... Tulisokibart (Merck) showed superior efficacy to placebo in achieving clinical remission in patients with moderately to severely active ulcerative colitis (UC).

6. 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.

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. academic.oup.com academic.oup.com/ecco-jcc/article/17/Supplement_1/i162/7009290

DOP87 The Anti-TL1A Antibody PRA023 Demonstrated Proof ... This Phase 2a multi-center, open-label study aimed to assess the efficacy and safety of PRA023 as induction treatment in adults with moderately to severely ...