An ulcerative colitis (UC) clinical study evaluating the safety of an investigational study medicine and how well it may work in resolving or improving symptoms compared to a placebo.
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Do you have inflammatory bowel disease (IBD)?
You may be eligible for a clinical study
About IBD
IBD is a chronic inflammation of the digestive system that can cause damage to the gastrointestinal tract.1,2 About 7 million people worldwide have IBD.2 IBD can cause abdominal pain, diarrhea, bloody stools, and rectal bleeding.3
There are two main types of IBD, ulcerative colitis (UC) and Crohn’s disease (CD).2 While there are treatments for IBD, there is no cure.
About these research studies
Researchers are evaluating an investigational study medicine in people with IBD, specifically those diagnosed with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). They are evaluating the safety of the investigational study medicine and how well it may work in resolving or improving UC and CD symptoms compared to a placebo. A placebo looks like the investigational study medicine but contains no active ingredients.
How to qualify
You may qualify to take part in one of these studies if you are 16 to 80 years old and have moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).
There are additional requirements that determine if you may qualify to be in one of these research studies 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 or CD and overall health will be closely monitored by a study doctor
- You may be reimbursed for study-related travel expenses
- You may help researchers learn more about UC, CD, and the investigational study medicine
Participation in a research study is voluntary, and you are free to leave it at any time. Your privacy will be maintained throughout the study.
Learn about the different studies
A Crohn’s disease (CD) clinical study evaluating the safety of an investigational study medicine and how well it may work in resolving or improving symptoms compared to a placebo.
View Study PageFor 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 IBD and help resolve or improve symptoms of UC and CD.
Frequently Asked Questions
About the IBD Studies
The IBD studies are evaluating the safety of an investigational study medicine and how well it may work in resolving or improving IBD symptoms compared to a placebo.
There are currently 2 studies enrolling: ATLAS-UC, for ulcerative colitis (UC), and ARES-CD, for Crohn’s disease (CD).
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.
A placebo looks like the investigational study medicine but does not contain any active medicine.
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 a 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 and ARES-CD studies is being evaluated to see how well it may work in resolving or improving symptoms compared to a placebo in people with moderately to severely active disease.
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/
What can you do next?
If you think one of these research studies might be a good fit and you are interested in taking part, take the next step to see if you are eligible. The study doctor will help determine which research study is the best fit for you.
Discuss with your doctor or care team
Print this page with details about the research studies, or email it to your doctor to discuss the research studies during your next visit.
Taking part in a research study is an important decision
If you are considering joining a research study, it is important to learn as much as you can about:
- The investigational study medicine that is being studied
- What the risks and benefits are for participants
Talk to your doctor about the research study before you decide to join.
Read our “What to Consider” page for more questions to ask and think about
References:
- Inflammatory Bowel Disease (IBD) Basics. CDC. Accessed September 11, 2024. https://www.cdc.gov/inflammatory-bowel-disease/about/index.html
- Inflammatory Bowel Disease (IBD). Mayo Clinic. Accessed September 11, 2024. https://www.hopkinsmedicine.org/health/conditions-and-diseases/inflammatory-bowel-disease
- GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2019. doi:10.1016/S2468-1253(19)30333-4.