Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

This research is looking at a new treatment called tulisokibart for people living with ulcerative colitis that is proving difficult to manage. The main goal is to find out if this new medicine can significantly reduce symptoms and help people achieve 'remission' (a period where symptoms greatly improve or disappear) compared to a placebo (a dummy medicine). Doctors will be checking two things: how well it works after 12 weeks, and for some people, how well it works after a full year. The study will also be carefully monitoring for any side effects of the treatment. This is a Phase 3 trial, meaning it's one of the final steps before a new medicine might become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

1,020

Start

25 Oct 2023

Estimated completion

01 Aug 2029

Ulcerative Colitis

What is this study about?

This study is designed to test a new medicine named tulisokibart for people who have ulcerative colitis (UC) that is active and causing moderate to severe symptoms. Ulcerative colitis is a long-term condition where the lining of the large intestine (colon and rectum) becomes inflamed and develops tiny ulcers, leading to symptoms like tummy pain, diarrhoea, and blood in your poo. When it's moderately to severely active, it means these symptoms are having a significant impact on daily life.

The main aim of this research is to see if tulisokibart can help people go into 'clinical remission'. This means your symptoms are much better, and there are signs your bowel is healing. The study will compare tulisokibart to a placebo, which looks like the real medicine but doesn't contain any active drug. This comparison helps researchers understand if any improvements are genuinely due to the new medicine or just other factors.

There are two main parts to this study. One part will look at how well the medicine works after 12 weeks, and for some participants, also after a full year. The other part will focus just on how well it works after 12 weeks. Researchers will also be carefully watching for any side effects the medicine might cause. This is an important step in developing new treatments that could help people manage their ulcerative colitis more effectively.

Key takeaways

This study is testing a new medicine (tulisokibart) for moderate to severe ulcerative colitis.
It aims to see if the medicine helps achieve remission compared to a dummy medicine (placebo).
Participation involves regular clinic visits, assessments, and receiving study medication.
The study will look at effects over 12 weeks and potentially up to a year.
You might receive the active medicine or a placebo.
All known risks and benefits will be explained, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to have been diagnosed with ulcerative colitis for at least three months and your condition must be considered moderately to severely active. You also need to weigh at least 40 kg (about 6 stone 4 pounds).

It's important that your current treatments for UC haven't worked well, you've lost their benefit, or you've found them difficult to tolerate. If you're currently taking other UC medicines, you might still be able to join, as long as they are stable and meet the study's requirements. The study is open to both men and women, aged 16 to 80 years old. If you are a woman who could become pregnant, special precautions will be discussed to ensure your safety.

However, you cannot join if you have Crohn's disease or other bowel conditions that could make it hard to tell if the treatment is working for UC. You also can't take part if your UC only affects your rectum, if you have very severe forms like fulminant colitis, or if you've already had surgery to remove your colon. These rules help make sure the study tests the medicine safely and on the right group of people.

Quick self-check

Do I have moderately to severely active ulcerative colitis?
Has my current UC treatment either stopped working, wasn't effective, or caused unbearable side effects?
Am I at least 16 years old and under 80?
Do I weigh at least 40 kg (about 6 stone 4 pounds)?
Have I not had surgery to remove my colon, or do I not have very severe forms of UC like fulminant colitis?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive either the new medicine, tulisokibart, or a placebo (a dummy medicine). These will be given either into a vein (IV) or under the skin (SC). You will have regular visits to the clinic for assessments, which will include examinations, blood tests, and other checks to see how you are doing and how the medicine is affecting you. Some participants will be in the study for up to 12 weeks, while others might continue for a full year. The total duration of your participation will depend on which part of the study you join. All study-related medication and assessments will be provided.

Potential risks and benefits

Potential benefits of joining could include receiving a new experimental treatment that might improve your ulcerative colitis symptoms and lead to remission. However, it's also possible that the treatment may not work for you, or you might receive the placebo. As with any medicine, there's a risk of side effects, and these will be carefully monitored throughout the study. You will be fully informed about all known risks before you decide to participate. Remember, taking part in any clinical trial is entirely voluntary, and you are free to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (476)

Digestive Health Specialists ( Site 0135)
Dothan, United States
IMC-Gulf Coast Gastroenterology ( Site 0157)
Fairhope, United States
Research Solutions of Arizona ( Site 3816)
Litchfield Park, United States
One of a Kind Clinical Research Center ( Site 3852)
Scottsdale, United States
GI Alliance - Sun City ( Site 0103)
Sun City, United States
Clinnova Research ( Site 3803)
Anaheim, United States
Southern California Research Center ( Site 3828)
Coronado, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)
La Jolla, United States
Cedars-Sinai Medical Center ( Site 0119)
Los Angeles, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)
Orange, United States
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)
Aurora, United States
Peak Gastroenterology Associates ( Site 0116)
Colorado Springs, United States

+464 more sites — see the official record for the full list.

Common questions

What is 'clinical remission'?

Clinical remission means your ulcerative colitis symptoms have significantly improved or disappeared, and your bowel shows signs of healing.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real treatment but contains no active drug. It helps researchers see if the actual medicine is truly effective.

Who is funding this research?

The study is sponsored by Merck Sharp & Dohme LLC, known as MSD outside of the US and Canada, a pharmaceutical company.

Will I know if I'm getting the real medicine or the placebo?

In this early stage of the study, neither you nor your study doctor will know if you are receiving the active medicine or the placebo. This is to ensure fair and unbiased results.

How long will I be in the study?

Depending on which part of the study you join, your participation could last for 12 weeks or possibly up to a year.