Have you been diagnosed with ulcerative colitis?
You may be eligible for a research study
About the ATLAS-UC Study
Researchers are testing an investigational study medicine called tulisokibart in people diagnosed with moderately to severely active ulcerative colitis (UC). They are evaluating the safety of the investigational study medicine and how well it may work in resolving or improving UC symptoms compared to a placebo. A placebo looks like the investigational study medicine but contains no active ingredients.
About the investigational study medicine
During the study, you will be assigned to get the investigational study medicine or a placebo.
The study medicine will be given 2 different ways:
- As an intravenous (IV) infusion into your vein; an IV pump will be used to deliver the investigational study drug over 30 minutes.
- As a subcutaneous (SC) injection just under the skin in your thigh, abdomen, or upper arm using an autoinjector device. You will be trained to give the injection to yourself. If you prefer, a family member or caregiver can be trained to give you the injections. Or you can have a member of the study team give you the injections at the study clinic.
Get study information for your reference.
NATIONAL TRIAL REFERENCE NUMBER
NCT06052059
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 research study if you are 16 to 80 years old and:
- You have had UC for at least 3 months and currently have moderately to severely active UC
- You have had at least 1 of the below:
- Have not responded well or stopped responding to at least 1 UC treatment
- Have not tolerated your dose of corticosteroids being reduced (such as prednisone, budesonide, or beclomethasone)
- Have not been able to tolerate taking at least 1 UC treatment
There are additional requirements that determine if you may qualify to be in this study, which the study doctor will discuss with you.
If you qualify and decide to participate:
- You will receive the study medicine and all study-related medical tests at no cost
- Your UC and overall health will be closely monitored by a study doctor
- You may be eligible to be reimbursed for study-related travel expenses
- You may help researchers learn more about UC and the investigational study medicine
Participation in the research study is voluntary, and you are free to leave it at any time. Your privacy will be maintained throughout the study.
What will happen during the study?
The ATLAS-UC Study is made up of 2 different studies. If you qualify and agree to take part, you will be in 1, but not both studies.
Will I receive the investigational study medicine?
Participants will be put into different groups to receive different doses of the investigational study medicine or a placebo. Participants, the study doctor, and the study team will not know which group each participant is placed in.
Key study facts
Study 1
Study Duration
Length of study: About a year and a half long
Study design: About 720 participants randomly assigned by a computer to one of 4 groups:
- Groups 1, 2, and 3 will get different doses of the investigational study medicine, tulisokibart
- Group 4 will get a placebo
There is an equal chance of being put into each group.
Trial start and end dates
- Actual study start date: 10-25-2023
- Estimated primary completion date: 11-21-2026
- Estimated study completion date: 12-17-2029
This study has up to 5 parts:
Screening
(up to 6 weeks)
At least 1 study visit for medical tests to see if you may qualify to be in this study.
Induction Period
(about 3 months)
5 visits to receive the investigational study medicine or a placebo by IV infusion.
Maintenance Period
(about 9 months)
7 visits to receive the investigational study medicine or a placebo by SC injection. If your UC symptoms are not responding well to the investigational study medicine, you may enter into a reinduction period.
Reinduction Period
(up to 3 months)
5 visits to receive the investigational study medicine by IV infusion. Participants in the reinduction period will not receive a placebo.
Follow-up
(about 14 weeks)
3 visits. You will no longer be taking the investigational study medicine or a placebo during this period.
Study 2
Study Duration
Length of study: A little more than a half-year long
Study design: About 300 participants randomly assigned by a computer to one of 3 groups:
- Groups 1 and 2 will get different doses of the investigational study medicine, tulisokibart
- Group 3 will get a placebo
There is an equal chance of being put into each group.
Trial start and end dates
- Actual study start date: 10-25-2023
- Estimated primary completion date: 11-21-2026
- Estimated study completion date: 12-17-2029
This study has up to 4 parts:
Screening
(up to 6 weeks)
At least 1 study visit for medical tests to see if you may qualify to be in this study.
Induction Period
(about 3 months)
5 visits to receive the investigational study medicine or a placebo by IV infusion. If your UC symptoms are not responding well to the investigational study medicine, you may enter into a reinduction period.
Reinduction Period
(up to 3 months)
5 visits to receive the investigational study medicine by IV infusion. Participants in the reinduction period will not receive a placebo.
Follow-up
(about 14 weeks)
3 visits. You will no longer be taking the investigational study medicine or a placebo during this period.
Extension period for both studies
If your UC responds well to the investigational study medicine, you will continue into an extension period which will last up to 3 years. During the extension period all participants will get the investigational study medicine by injection.
About ulcerative colitis
More than 5 million people worldwide have ulcerative colitis. It can cause pain, stomach cramps, bloody diarrhea, and rectal bleeding. There are treatments for UC, but no cure.
For healthcare professionals
Tulisokibart is being tested to see if it may control the inflammation (a painful reaction from the immune system) and fibrosis (thickening or scarring of tissue) caused by UC and help resolve or improve its symptoms.
Frequently Asked Questions
About the ATLAS-UC Study
The ATLAS-UC Study is evaluating the safety of an investigational study medicine and how well it may work in resolving or improving UC symptoms compared to a placebo.
Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the research study’s 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, Costs, and Permission
The study 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 Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.
Your participation in the research study 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 study team before doing so. You will be asked to return to the study site at least once to complete a final visit and return any unused drug.
No, you will receive the study medicine at no cost. You will also get all study-related medical tests at no cost.
No, your doctor does not have to give permission for you to participate. However, either you or the study 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 Research Studies
A research study, also known as a clinical trial, tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational study medicine is safe and effective. These studies 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 research studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.
Before a research study can begin, a review board or ethics committee must review the research study. In the U.S., 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 research study may take part. The study 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 study team determine whether you may be eligible.
An investigational study medicine is a drug that hasn’t yet been approved for use in the general public. In order for it to be approved, the investigational study medicine must be tested in research studies to see if it is safe and effective for treating the target disease in certain groups of people.
The investigational study medicine in the ATLAS-UC Study is being tested to see how well it may work in resolving or improving UC symptoms compared to a placebo in people with moderately to severely active ulcerative colitis.
An intravenous (IV) infusion delivers a liquid medicine directly into a vein using a needle or tube. This allows medications to be delivered directly into the bloodstream.
An autoinjector device delivers an injection just under the skin in your thigh, abdomen, or upper arm. You will be trained to use this device to give an injection to yourself. If you prefer, a family member or caregiver can be trained to give you the injections. Or you can have a member of the study team give you the injections at the study clinic.
A placebo looks like the investigational study medicine but does not contain any active medicine. Researchers use a placebo to see if the investigational study medicine works better or is safer than taking nothing.
- In Study 1, there is a 3 out of 4 (75%) chance of receiving the investigational study medicine, and a 1 in 4 (25%) chance of receiving a placebo
- In Study 2, there is a 2 out of 3 (67%) chance of receiving the investigational study medicine, and a 1 in 3 (33%) chance of receiving a placebo
- During the optional extension period all participants will receive the investigational study medicine
If your UC responds well to the study medicine, you will continue into a long-term extension period which could last up to 3 years. During the extension period all participants get the investigational study medicine by injection.
If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.
For more answers to your questions visit: https://www.merckclinicaltrials.com/faq/
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible 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