Have you been diagnosed with ulcerative colitis?
You may be eligible for a clinical trialClinical Study / Clinical TrialA way to learn how the body responds to a medicine, vaccine, or medical device. [This is done to see if it is safe and works in people.]
About the MK-8690-002 trial
Researchers want to learn about an investigational drug called MK-8690 in people with moderately to severely active ulcerative colitis.
The goals of this trial are to:
- Test the safetySafe / SafetyAn assessment of the likelihood of causing an undesired effect of MK-8690
- See whether the investigational drug, MK-8690, may work to treat moderately to severely active ulcerative colitis compared to a placebo. A placebo looks like the investigational drug but contains no active ingredients.
The safety and efficacy of MK-8690 has not yet been proven in ulcerative colitis or other conditions.
About the investigational drug
If you qualify and decide to join, you will be randomly (by chance) assigned by a computer to get either the investigational drug, MK-8690, or placebo. Using a placebo helps researchers better understand the actual effects of an investigational drug.
You, the trial doctor, and the trial team will not know whether you are getting the investigational drug or the placebo. However, in case of a health emergency, they can find out.
You will get your assigned trial drug as a subcutaneous injectionSubcutaneous injectionShot given under the skin (a shot under the skin), in your thigh, abdomen, or upper arm. The trial staff will give you the injection at the trial site.
NATIONAL TRIAL REFERENCE NUMBER
NCT07463183
When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.
Thinking about taking part?
Your doctor is your best resource for deciding if a study is right for you, but your personal support team can also help you along the way.
How to qualify
You may qualify to take part in this clinical trial if you:
- Are 18 to 75 years old
- Have moderately to severely active UC that has not responded well to treatment
If you qualify and decide to participate:
- You will get the investigational drug or placebo and all trial-related medical tests at no cost to you.
- You will be closely monitored by a trial doctor.
- You may be eligible to be reimbursed for trial-related travel expenses.
- Joining the trial is voluntary, and you can leave the trial at any time and for any reason.
What will happen during the trial?
If you qualify and decide to participate, you will be in this trial for about 1.5 years and visit the trial site about once or twice a month.
Will I receive the investigational drug?
Participants will be placed into different groups to receive either the investigational drug or a placebo. Participants, the trial doctor, and the trial team will not know which group each participant is placed in.
Key trial facts
Trial Duration
Length of trial: About a year and a half long
Trial design: About 100 participants randomly assigned by a computer to 1 of 2 groups to receive either the investigational drug or a placebo during the Induction Period. After the first 3 months of treatment, all participants will receive the investigational drug during the Reinduction Period (if applicable) or Extension Periods.
Trial start and end dates
- Actual study start date: 03-24-2026
- Estimated primary completion date: 10-28-2027
- Estimated study completion date: 12-21-2028
This trial has up to 5 parts:
Screening
(up to 6 weeks)
At least 1 trial visit for medical tests to see if you may qualify to be in this trial.
Induction Period
(about 3 months)
Up to 10 visits to check on your health and receive your assigned trial drug as an injection under the skin.
Reinduction Period (if applicable)
(about 3 months)
Up to 10 visits to check on your health and receive the investigational drug if you did not respond to the assigned trial drug in the induction period (if applicable).
Extension Period
(about 10 months)
Up to 13 visits to check on your health and receive the investigational drug if you responded well to your assigned trial drug in the Induction or Reinduction Periods.
Follow-up Period
(about 18 weeks)
3 visits to check on your health after stopping the investigational drug.
About ulcerative colitis
Ulcerative colitis (UC) is a chronicChronicA condition that is long lasting or ongoing inflammatory bowel disease (IBD) that affects the large intestineIntestinesThe tube that food goes through when it is swallowed, digested, and then passed as the waste products in stool (colon). More than 5 million people worldwide have UC. It can cause pain, stomach cramps, bloody diarrhea, and rectal bleeding. There are treatments for UC, but no cure.
Trial Locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
Frequently Asked Questions
About the MK-8690-002 trial
Researchers want to learn about an investigational drug called MK-8690 in people with moderately to severely active ulcerative colitis.
The goals of this trial are to:
- Test the safety of MK-8690
- See whether the investigational drug, MK-8690, may work compared to a placebo. A placebo looks like the investigational drug but contains no active ingredients.
You will visit the trial site on a regular schedule so that the trial doctors can see how the trial drugs are working for you. During your trial visits, you may get:
- Blood tests
- Physical exams
- Investigational drug
- Imaging scans such as CT scans or MRIs
You can ask your trial doctor any questions you have about what happens during trial visits and how often they will happen. If you are able to join the trial, your trial doctor will need to stay in contact with you even after your trial visits are over. This is very important because this clinical trial is studying how well the study treatment works over time.
If you meet all of the study criteria, you will be randomly (by chance) assigned by a computer to get either the investigational drug, MK-8690, or placebo.
Before you agree to participate, the trial team will review all aspects of the clinical trial with you. If you decide to take part, you will be given a document called an Informed Consent FormInformed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant’s rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial) that provides, in writing, the clinical trialˇs purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
Privacy, withdrawing, and permission
The trial team respects and protects your privacy and will not share your information, except as required by law, and will store your personal information with codes that do not identify you. The Informed Consent FormInformed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant’s rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial) (completed by you prior to participation) will provide more information about how your privacy will be maintained.
Your participation in the clinical trial is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the trial team before doing so. You will be asked to return to the trial site at least once to complete a final visit and return any unused drug.
No, your doctor does not have to give permission for you to participate. However, either you or the trial doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up-to-date about your progress.
About clinical trials
A clinical trial tries to answer questions about how medicines work in the people who take them. Researchers run trials to test whether an investigational drug is safe and effective. These trials may help doctors find new ways to help prevent, detect, or treat health problems.
Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for clinical trials. These rules are put in place to make sure clinical trials follow strict scientific and ethical guidelines.
Before a clinical trial can begin, a review board or ethics committee must review the clinical trial. In the United States, this group is called an IRB or Institutional Review Board. An IRB is made up of doctors, scientists, and other members of the community.
Only people who meet all eligibility criteria for a clinical trial may take part. The trial team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate. You may also be asked to provide information from your medical records to help the trial team determine whether you may be eligible.
An investigational drug is a drug that hasn’t yet been approved for use in the general public. In order for it to be approved, the investigational drug must be tested in clinical trials to see if it is safe and effective for treating the target disease in certain groups of people.
A placebo is a material that looks like the investigational drug but does not contain any active medicine. Researchers use a placebo to see if the investigational drug works better or is safer than taking nothing.
During the Induction Period, there is a chance you will receive a placebo. During the Reinduction and Extension Periods, all participants receive the investigational drug.
If you have questions about this trial or taking part, contact the trial site closest or most convenient for you. Use the map above to find contact information.
Understanding clinical trials is important when making a decision about joining one. To see more Frequently Asked Questions, click on the link below.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, it is important to learn as much as you can about:
- The investigational drug that is being studied
- What the risks and benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about