Crohn Disease study: Tulisokibart
Official title Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
ClinicalTrials.gov ID: NCT06651281
What this study is testing
What is Tulisokibart?
An investigational subcutaneous antibody being studied for Crohn’s disease. It is designed to bind the cytokine TL1A in the body.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe tulisokibart is over a longer period and whether people can keep taking it without problems.
- Who it's for
- Adults who have Crohn’s disease or ulcerative colitis and have already received tulisokibart in a previous study.
- What's involved
- Participants will continue to receive tulisokibart and will have regular check‑ups and tests to monitor safety and tolerance.
- Time commitment
- The study lasts for the remaining period of the parent study, with visits scheduled as directed by the investigators.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Has participated in a qualifying tulisokibart parent study for CD or UC
- The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed...
- A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of...
- A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by...
- A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle...
You likely can't join if
- Has prematurely discontinued study intervention in their parent study
- Has received any protocol-specified prohibited medications during their parent study
- Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
The study team makes the final eligibility decision.
Where it is enrolling
- Bristol, Connecticut, United States
- Ypsilanti, Michigan, United States
- Liberty, Missouri, United States
- New York, New York, United States
- Garland, Texas, United States
- Lubbock, Texas, United States
- San Antonio, Texas, United States
- Southlake, Texas, United States
- Tyler, Texas, United States
- Charlottesville, Virginia, United States
- Tacoma, Washington, United States
- Brno, Brno-mesto, Czechia
- Hradec Králové, Czechia
- Nice, Alpes-Maritimes, France
- Neuilly-sur-Seine, Hauts-de-Seine, France
- Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
- Lille, Nord, France
- Tbilisi, Georgia
- Békéscsaba, Bekes County, Hungary
- Budapest, Hungary
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bristol, Connecticut, United States; Ypsilanti, Michigan, United States; Liberty, Missouri, United States; New York, New York, United States; Garland, Texas, United States; Lubbock, Texas, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.