You may be eligible for a clinical research study
The MK7240-012 Study is testing 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 called tulisokibart in people who have moderate to severe hidradenitis suppurativa (HS). They are evaluating the safety of the investigational study medicine and how well it may work in resolving or improving HS symptomsSymptomSomething a person feels and may be a sign of a disease or condition compared to a placeboPlaceboA placebo looks like the study medicine but has no study medicine/treatment in it. Using a placebo helps researchers better understand the effects of the study medicine/treatment.. A placebo looks like the investigational study medicine but contains no active ingredients. This study will also test different doses of the investigational study medicine. The investigational study medicine is experimental. It has not been approved to treat HS.
During the study, you will be assigned to get the investigational study medicine or a placebo.
The investigational study medicine is given by a subcutaneous injectionSubcutaneous injectionShot given under the skin just under the skin in your thigh, abdomen, or upper arm using an autoinjector device. You will be trained to give the injectionsInjectionTo give medicine/treatment with a syringe and needle. Also called- Shot, Jab 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.
NATIONAL TRIAL REFERENCE NUMBER
NCT06956235
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Your doctor is your best resource for deciding if a studyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo) is right for you, but your personal support team can also help you along the way.
You may qualify to take part in this clinical research study if you:
Are 18 to 75 years old
Have moderate to severe HS
Have had symptoms for at least 6 months
There are additional requirements that determine if you may qualify to be in this study, which the study doctor will discuss with you.
You will receive the study medicine and all study-related medical tests at no cost
Your HS 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 HS and the investigational study medicine
Participation in the study is voluntary, and you are free to leave it at any time. Your privacy will be maintained throughout the study.
If you qualify and agree to take part, you will be in the study for about 19 months and may have the option to stay in the study for an additional 15 months.
You will receive the investigational study medicine or a placebo for the first 4 months and then all participants will receive the investigational study medicine for about 9 months. Participants, the study doctor, and the study team will not know which group each participant is placed in.
Length of study: Up to 2½ years
Study design: Approximately 150 participants randomly assigned by a computer to 1 of 4 groups to receive different doses of tulisokibart or a placebo. After the first 4 months of treatment, all participants will receive tulisokibart.
(up to 5 weeks)
At least 1 study visit for medical tests to see if you may qualify to be in this study.
(about 14 months)
Participants will receive the investigational study medicine or a placebo for 4 months, then all participants will receive the investigational study medicine for about 9 months. Study site visits will occur:
Every 2 weeks for the first month
Then every 4 weeks for 5 months
Then every 8 weeks for 8 months
(about 15 months)
Participants will continue to receive the investigational study medicine. There will be about 5 visits to the study site.
(up to 3½ months)
After participants stop taking the investigational study medicine, they will enter a follow-up period that includes 2 phone or virtual visits and at least 1 visit to the study site.
Hidradenitis suppurativa (HS) is a chronicChronicA condition that is long lasting or ongoing inflammatory skin condition that causes small, painful lumps to form under the skin. These lumps can break open and release fluid, or tunnels can form under the skin. This usually takes place in areas where skin rubs together, such as armpits. There is no cure for HS, but some treatments are available.
Tulisokibart is being tested to see if it may help control the inflammationInflammationRedness, swelling, pain, and increased warmth or heat in the area (a painful reaction from the immune system) and fibrosis (thickening or scarring of tissue) caused by HS and help resolve or improve its symptoms.
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest study site. Talk with a study site member for more information.
The MK7240-012 Study is evaluating the safety of an investigational study medicine and how well it may work in resolving or improving HS symptoms compared with 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 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 risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
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 clinical 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.
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 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. 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 United States, this group is called an IRB or Institutional Review BoardInstitutional Review Board (IRB)(In US): A team of people who review studies to protect the rights and welfare of study participants; A group formally designated and responsible for reviewing study proposals, monitoring studies involving people and protecting the rights and welfare of study participants. 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 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 MK7240-012 Study is being tested to see how well it may work in resolving or improving HS symptoms compared with a placebo in people with moderate to severe hidradenitis suppurativa (HS).
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 is a material that looks like the investigational study medicine but does not contain any active medicine. Researchers use a placebo to see if the investigational study works better or is safer than taking nothing. During the first 4 months of treatment, you will have a 2 in 7 (about 30%) chance of receiving a placebo, and a 5 in 7 (about 70%) chance of receiving the investigational study medicine. After that, all participants will receive the investigational study medicine.
You may have the option to join a long-term extension period that could last up to 15 months. 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/
If you think this clinical study might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Print this page with details about the study or email it to your doctor to discuss the clinical trial during your next visit.
Get help talking with your doctor or care team
NATIONAL TRIAL REFERENCE NUMBER
NCT06956235
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
If you are considering joining a clinical research study, it is important to learn as much as you can about:
Talk to your doctor about the clinical study before you decide to join.
Read our “What to Consider” page for more things to think about and questions to ask
