Tulisokibart for Ulcerative Colitis

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Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, HIV, Tuberculosis, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how a new treatment for ulcerative colitis, called tulisokibart, moves through the body when given as a single dose. It compares three methods of administration: one using an autoinjector and two using a syringe and vial, each with different concentrations. Individuals who are generally healthy, have a body mass index (BMI) between 18 and 32, and weigh between 50 and 100 kg might be suitable candidates for this trial. The goal is to better understand the treatment's process in the body to aid its further development. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

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

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

Research has shown that tulisokibart is being tested for people with ulcerative colitis. Studies are examining its safety and effectiveness. Although specific safety details are not yet available, tulisokibart is also in later-stage trials for other conditions like Crohn's disease, suggesting earlier studies found it safe.

In this trial, participants will receive a single dose of tulisokibart, either with an autoinjector or a syringe and vial. Both methods are being tested to assess how the body processes the drug. As this trial is in the early stages, complete safety information is not yet available. However, tulisokibart's progression in studies for other conditions suggests it is generally well-tolerated in humans so far. Researchers will closely monitor participants in the current trial to ensure the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for ulcerative colitis, which often include oral or intravenous medications like mesalamine or biologics such as infliximab, Tulisokibart is a novel option administered subcutaneously. Researchers are excited about Tulisokibart because it offers three distinct approaches: Treatment A uses an autoinjector for a quick and easy single dose, while Treatments B and C introduce variations in concentration delivered with a syringe and vial for more tailored dosing. This method of delivery could potentially improve patient convenience and adherence, while the new formulation might target inflammation in a unique way, offering hope for more effective symptom relief.

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

Research has shown that tulisokibart may help treat ulcerative colitis. Studies have found it works better than a placebo, significantly improving symptoms. Tulisokibart targets a protein called TL1A, which plays a role in inflammation and tissue damage. In this trial, participants will receive different formulations of tulisokibart: some will receive a single dose delivered subcutaneously with an autoinjector, while others will receive varying concentrations delivered with a syringe and vial. Previous trials demonstrated that patients with moderate to severe ulcerative colitis had better results with tulisokibart than those who did not take it. This suggests tulisokibart could be an effective option for managing this condition. ^{3 4 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 individuals weighing between 50 and 100 kg, in good health, with a BMI of 18 to 32. It's designed for those with ulcerative colitis to test the drug Tulisokibart administered via an autoinjector or syringe.

Inclusion Criteria

I am in good health overall.

Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive

My weight is between 50 and 100 kg.

Exclusion Criteria

Consumes greater than 3 servings of alcoholic beverages per day

Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food

Has a positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV); OR positive hepatitis B core antibody (HBcAb) with negative hepatitis B core antibody (HBsAb

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of tulisokibart via autoinjector or syringe

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics and safety through blood collection at specified time points

14 weeks

Multiple visits (in-person) on Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 29, 57, 71, and 99

What Are the Treatments Tested in This Trial?

Interventions

• Tulisokibart

Trial Overview The study aims to understand how the body processes a single dose of Tulisokibart when given subcutaneously (under the skin) using either an autoinjector or vial/syringe at different concentrations.

How Is the Trial Designed?

Group I: Treatment C Experimental Treatment 1 Intervention

Single dose of concentration B delivered SC with syringe and vial

Group II: Treatment B Experimental Treatment 1 Intervention

Single dose of concentration A delivered SC with syringe and vial

Group III: Treatment A Experimental Treatment 1 Intervention

Single dose delivered subcutaneously (SC) with an autoinjector

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

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/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).

3. 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 ...

4. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i1158/7967681

P0580 Efficacy and safety results of tulisokibart re-induction ... Tulisokibart is a monoclonal antibody that targets tumor necrosis factor-like cytokine 1A (TL1A), a regulator of inflammation and fibrosis ...

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

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. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06052059/

Have you been diagnosed with ulcerative colitis? Researchers are testing an investigational study medicine called tulisokibart in people diagnosed with moderately to severely active ulcerative colitis (UC).

7. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-tulisokibart-for-patients-with-moderate-to-severe-ulcerative-colitis/

Study on the Effectiveness and Safety of Tulisokibart ... This clinical trial assesses the effectiveness and safety of Tulisokibart, a new treatment under investigation for patients suffering from ...

8. withpower.com withpower.com/trial/tulisokibart-for-ulcerative-colitis-2b0b6

Tulisokibart for Ulcerative Colitis · Info for Participants Participants receive a single subcutaneous dose of tulisokibart via autoinjector or syringe. 1 day. 1 visit (in-person). Follow-up. Participants are monitored ...