A Crohn’s disease (CD) clinical study evaluating the safety of an investigational study medicine and whether it may work in resolving or improving symptoms compared to a placebo.
View Study Page
Do you have an autoimmune disease?
You may be eligible for a clinical research study
About Autoimmune Diseases1-3
Our immune systemImmune systemA system of the body that includes cells, tissues, and organs that helps the body fight infection or illness; the body’s natural defenses against germs and illness; the body’s ability to fight germs and illness is designed to protect us against substancesSubstanceA matter or material with a specific structure and function like virusesVirusVery small germs that need to be in a person to multiply and survive; germs that can cause infection that can’t be treated with antibiotics, bacteria, and poisons that invade our bodies and attack different parts of it. But sometimes the immune system does just the opposite of what it is supposed to do—it attacks different parts of the body instead of protecting them. This can cause a variety of symptomsSymptomSomething a person feels and may be a sign of a disease or condition including inflammationInflammationRedness, swelling, pain, and increased warmth or heat in the area, digestive issues, and joint pain and stiffness.
Autoimmune diseasesAutoimmune diseaseA condition when the body attacks itself are not uncommon. There are over 100 of them, and it is estimated that 1 in 15 people in the US has an autoimmune diseaseAutoimmune diseaseA condition when the body attacks itself. No one really knows what causes autoimmune diseases, and there are no cures for them. They are chronicChronicA condition that is long lasting or ongoing and often life long conditionsConditionHealth problem; an illness or disease; how a person feels. Researchers continue to study what makes the immune systemImmune systemA system of the body that includes cells, tissues, and organs that helps the body fight infection or illness; the body’s natural defenses against germs and illness; the body’s ability to fight germs and illness fail to work. Our goal is to create new therapies and treatments that can help manage symptoms for those with immune and autoimmune disorders.
About the Studies
Researchers are testing an investigational study medicine called tulisokibart in people with autoimmune diseasesAutoimmune diseaseA condition when the body attacks itself such as ulcerative colitis (UC), Crohn’s diseaseCrohn’s diseaseA disease that causes swelling and ulcers (sores) in the digestive tract. Symptoms include pain, loose and watery stools (diarrhea), feeling tired, mouth sores, fever, and weight loss. Symptoms can come and go. (CD), hidradenitis suppurativa (HS), ankylosing spondylitis (AS), and rheumatoid arthritisRheumatoid arthritis (RA)A chronic condition with pain, swelling and stiffness of the joints caused by the immune system attacking the tissues in the joints. (RA). They are evaluating tulisokibart’s safetySafe / SafetyAn assessment of the likelihood of causing an undesired effect and whether it may work in resolving or improving the symptomsSymptomSomething a person feels and may be a sign of a disease or condition of these conditionsConditionHealth problem; an illness or disease; how a person feels.
Learn about the different studies
An ankylosing spondylitis (AS) research study evaluating the safety of an investigational study medicine and whether it may work in resolving or improving symptoms compared to a placebo.
View Study Page
A rheumatoid arthritis (RA) research study evaluating the safety of an investigational study medicine and whether it may work in resolving or improving symptoms compared to a placebo.
View Study Page
How to qualify
Studies are being conductedConductCarry out; Do for different autoimmune diseasesAutoimmune diseaseA condition when the body attacks itself. Check the list of current studies to see if there is one that interests you. A study doctor will be able to tell you more about the eligibility requirementsEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion Criteria for each study.
If you qualify and decide to participate:
- You will receive the study medicineDrug (or medicine, medication, treatment)Medicine being studied in the clinical trial; study medication; study treatment. and all study-related medical tests at no cost
- Your autoimmune diseaseAutoimmune diseaseA condition when the body attacks itself 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 autoimmune diseasesAutoimmune diseaseA condition when the body attacks itself and the investigational study medicineInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied
Participation in the studies is voluntary, and you are free to leave at any time. Your privacy will be maintained throughout the study.
About the Investigational Study Medicine
The investigational study medicineInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied, tulisokibart, is being tested to see if it may help resolve or improve symptomsSymptomSomething a person feels and may be a sign of a disease or condition caused by autoimmune diseasesAutoimmune diseaseA condition when the body attacks itself including inflammationInflammationRedness, swelling, pain, and increased warmth or heat in the area (a painful reaction from the immune system) and fibrosis (thickening or scarring of tissueTissueA group of cells that are alike; the material that organs, muscles, skin and other body parts are made up of).
Frequently Asked Questions
About the MK7240 Studies
The MK7240 Studies are evaluating the safetySafe / SafetyAn assessment of the likelihood of causing an undesired effect of an investigational study medicineInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied and whether it may work in resolving or improving autoimmune diseaseAutoimmune diseaseA condition when the body attacks itself symptomsSymptomSomething a person feels and may be a sign of a disease or condition.
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 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 research study’s purpose, assessmentsAssessmentA test; A measurement, procedures, potential benefits and risksRiskChance (likelihood) for an event, reaction or health problem to happen, 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 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 a research study is entirely voluntaryVoluntaryTo choose to participate; to do something by choice; to participate because a person wants to; to participate without being forced or made to 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 medicineInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied is safeSafe / SafetyAn assessment of the likelihood of causing an undesired effect and effective. These studies may help doctors find new ways to help prevent, detect, or treat health problems.
ParticipantParticipantPerson; people in a clinical trial. safetySafe / SafetyAn assessment of the likelihood of causing an undesired effect 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 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 criteriaEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion Criteria for a clinical 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 medicineInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied 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 MK7240 Studies is being tested to see whether it may work in resolving or improving symptomsSymptomSomething a person feels and may be a sign of a disease or condition in people with certain autoimmune diseasesAutoimmune diseaseA condition when the body attacks itself.
A placebo looks like the study medicine but has no study medicine/treatment in it. Using a placebo helps researchers better understand the effects of a study medicine/treatment.
If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.
Understanding research studies is important when making a decision about joining one. To see more Frequently Asked Questions, click on the link below.
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.
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 medicineInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied that is being studied
- What the possible risksRiskChance (likelihood) for an event, reaction or health problem to happen and benefits are for participantsParticipantPerson; people in a clinical trial.
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.