At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tulisokibart (drug), Placebo to tulisokibart (drug)
- How long the study runs
- Study runs about 157 months (dates as stated)
- About the drug or intervention
- Tulisokibart — drug: Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously · Placebo to tulisokibart — drug: Placebo matching SC tulisokibart
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- Not specified
- Who
- All
- Number of participants
- 1,380
- Started
- 2024-11-25
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for crohn disease
- • Phase3 - 1,380 participants
- • Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study
Who can take part?
- • Adults
- • Diagnosed with crohn disease
Where?
- • Prescot - MAC Research - Merseyside ( Site 3401)
- • London - Whipps Cross University Hospital ( Site 3400)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Not specified
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test)
What the study is looking for
- ✓Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
- ✓The investigator determines that the participant derives clinical benefit from continued study intervention based...
- ✓A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at...
- ✓A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their...
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (2 UK sites)
MAC Research - Merseyside ( Site 3401)
Prescot L34 1BH, United Kingdom
Whipps Cross University Hospital ( Site 3400)
London E11 1NR, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT