RecruitingPHASE3INTERVENTIONAL

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

This is an extension study for a medicine called tulisokibart, also known as MK-7240. It's for people with Crohn's disease or ulcerative colitis who have previously taken part in other studies testing this medicine. The main goal is to understand the long-term safety of tulisokibart and how well people tolerate it when used over a longer period. Researchers also want to see if it continues to be effective in managing these conditions. By extending the study, they can gather more comprehensive information about its effects over time, helping to ensure it's a safe and beneficial treatment option for those with moderate to severe Crohn's or ulcerative colitis.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

1,380

Start

25 Nov 2024

Estimated completion

17 Dec 2037

Crohn Disease Colitis, Ulcerative

What is this study about?

This research is an 'extension study' for a medicine called tulisokibart (you might also see it referred to as MK-7240). An extension study means it's designed for people who have already taken part in previous studies of this medicine for Crohn's disease or ulcerative colitis. The idea behind it is to continue following these individuals to gather more information over a longer period.

Tulisokibart is being developed as a potential treatment for active, moderate to severe Crohn's disease and ulcerative colitis. These are conditions that affect your gut and can cause inflammation and other difficult symptoms. The main reasons for this extension study are to keep a close eye on the safety of tulisokibart over a longer time and to see if people continue to tolerate the medicine well. This is really important to make sure any new medicine is not just effective but also safe for long-term use.

By carefully monitoring people who continue to receive tulisokibart, researchers can learn more about any potential side effects that might only show up after a longer period, and how consistently it helps manage the condition. This information is vital for understanding the full picture of how tulisokibart works and if it could become a widely available treatment in the future.

Key takeaways

It's an extension study for a drug called tulisokibart (MK-7240).
It's for people with Crohn's disease or ulcerative colitis who were in previous studies.
The main aims are to monitor long-term safety and how well the medicine is tolerated.
Participation requires your doctor to feel you benefit from the treatment.
This research helps understand if tulisokibart is a safe and effective long-term treatment.

Who may be eligible?

To be able to join this study, you must have already taken part in a previous study of tulisokibart for Crohn's disease or ulcerative colitis. The doctor who looked after you in the previous study will also need to believe that you are benefiting from the treatment and that it's good for you to continue. This study is open to both men and women of all adult ages.

If you are a woman of childbearing potential, you must not be pregnant or breastfeeding. You would also need to either agree to use reliable contraception throughout the study and for 14 weeks after your last dose, or confirm that you are not sexually active with men.

Unfortunately, you cannot join this study if you stopped taking the study medicine early in your previous study, or if you received any medications that were not allowed during that study. You also cannot participate if you know you are allergic or sensitive to tulisokibart or any of its ingredients.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I previously participated in a tulisokibart study for Crohn's or ulcerative colitis?
Does my previous study doctor believe I am benefiting from tulisokibart?
If I am a woman of childbearing potential, am I able to use reliable contraception or am I not sexually active with men?
Do I have any known allergies to tulisokibart or its ingredients?
Did I complete my previous study without stopping the medicine early?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue to receive the study medicine, tulisokibart, which you would have been taking in a previous study. You will have regular appointments with the study team, who will monitor your health, check for any side effects, and see how well the medicine is working. These appointments will involve check-ups, blood tests, and discussions about your symptoms. The exact number and frequency of visits, as well as the total length of your participation, will be explained in detail by the study team. You will be closely followed up during your time in the study and for a period after your last dose of the study medicine.

Potential risks and benefits

Participating in this study might offer you continued access to a treatment that you've already found beneficial for your Crohn's disease or ulcerative colitis. You'll also be contributing valuable information that could help others with these conditions in the future. However, like all medicines, tulisokibart could have side effects, and some might only become apparent with longer use. The study team will carefully monitor you for these. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Connecticut Clinical Research Institute ( Site 0297)
Verified postcode
Bristol, United States· Recruiting
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
Verified postcode
Ypsilanti, United States· Recruiting
BVL Research - Kansas ( Site 0292)
Verified postcode
Liberty, United States· Recruiting
New York Gastroenterology Associates ( Site 0253)
Verified postcode
New York, United States· Recruiting
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
Verified postcode
Garland, United States· Recruiting
GI Alliance - Lubbock ( Site 0288)
Verified postcode
Lubbock, United States· Recruiting
Caprock Gastro Research ( Site 0293)
Verified postcode
Lubbock, United States· Recruiting
Southern Star Research Institute ( Site 0299)
Verified postcode
San Antonio, United States· Recruiting
GI Alliance - Southlake ( Site 0298)
Verified postcode
Southlake, United States· Recruiting
Tyler Research Institute ( Site 0294)
Verified postcode
Tyler, United States· Recruiting
University of Virginia Health System ( Site 0291)
Verified postcode
Charlottesville, United States· Recruiting
Washington Gastroenterology - Tacoma ( Site 0295)
Verified postcode
Tacoma, United States· Recruiting

Common questions

What is an 'extension study'?

An extension study is for people who have already been in an earlier study of a new medicine. It allows researchers to learn more about the medicine's long-term effects.

What is tulisokibart for?

Tulisokibart is a medicine being tested to treat moderate to severe Crohn's disease and ulcerative colitis, conditions that cause inflammation in the gut.

What are the main goals of this study?

The main goals are to check the long-term safety of tulisokibart, see how well people tolerate it over time, and continue to assess how effective it is.

Do I have to take part?

No, taking part in any study is entirely your choice. You can decide not to join or leave at any time without it affecting your medical care.

Will I receive actual medicine or a dummy treatment?

In this extension study, you would receive tulisokibart. If you were on a dummy treatment (placebo) in the previous study, you would now get the active medicine.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.