Crohn's Disease study: IV Tulisokibart vs SC Tulisokibart
Official title A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
ClinicalTrials.gov ID: NCT06430801
What this study is testing
What is IV Tulisokibart?
This is an investigational medicine being studied as a potential treatment for moderately to severely active Crohn's disease. It is designed to bind to a specific protein in the body called TL1A.
Also referred to as PRA023, MK-7240.
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
- This study is testing whether tulisokibart can help people with moderate to severe Crohn's disease get better. It compares the drug to a pretend treatment with no medicine.
- Who it's for
- You may be able to join if you have moderate or severe Crohn's disease and are not taking certain other medicines.
- What's involved
- You would take the drug or a pretend treatment at home. You will have visits to the clinic for check‑ins and tests. The study looks at how many people feel better and how the gut looks after treatment.
- Time commitment
- The study lasts about a year, with visits at the start, at 12 weeks, and at 52 weeks to see how you are doing.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 80
You may be able to join if
- The main inclusion and
You likely can't join if
- Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
- Has moderately to severely active CD.
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids...
- Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture...
See the full eligibility criteria
- The main inclusion and
- Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
- Has moderately to severely active CD.
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule...
- Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis...
- Has current stoma or need for colostomy or ileostomy.
- Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
- Has surgical bowel resection within 3 months of study.
- Has prior or current gastrointestinal dysplasia.
- Has chronic infection requiring ongoing antimicrobial treatment.
- Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years.
- Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Has active tuberculosis.
- Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
The study team makes the final eligibility decision.
Where it is enrolling
- Sun City, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Coronado, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Oxnard, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Englewood, Colorado, United States
- Lakewood, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Fort Myers, Florida, United States
- Inverness, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
+ 341 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, 16 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sun City, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Coronado, California, United States; Lancaster, California, United States and 355 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.