A potential new treatment for ulcerative colitis (ATLAS-UC)
This trial is testing MK-7240 in people with moderately to severely active ulcerative colitis (UC).
MK-7240 is experimental. It has not been approved in Australia.
This trial will compare MK-7240 to placebo. A placebo looks like a trial drug, but it has no active ingredients.
This trial is being done to:
• Test the safety of MK-7240
• See how well MK-7240 works, compared to placebo
MK-7240 is a monoclonal antibody (man-made antibodies that act like human antibodies in the immune system) that may reduce inflammation and
fibrosis (scar tissue) associated with inflammatory bowel disease, such as UC and Crohn’s disease.
What you need to know
Who can take part?
To participate you must:
- Be aged between 16 & 75
- Have moderately to severely active UC
- Weigh at least 40kg
- Meet the prior treatment inclusion criteria
- Not be pregnant or planning pregnancy
- Not have any other bowel condition
- Not have received a fecal transplant in the 4 weeks prior to study entry
- Not have an current or recent infection
- Not have a history of malignancy
- Certain medication may make you ineligible to participate
What is involved for me?
- Medical history and collection of demographic information
- Vital signs
- Electrocardiogram
- Physical exam
- Blood and urine tests
- Pregnancy tests for women with childbearing potential
- Colonoscopy with tissue biopsy
- Daily diary completion
- Questionnaires
- Regular study visits
- Treatment by IV infusion then later on by subcutaneous injection