During the screening period, we would complete several assessments and checks of your health to see if one of the studies would be a good fit for you.
You know Crohn’s. We know science.
That’s why we’re working to create a world with additional effective treatments for Crohn’s disease. But we can only do it with your help.
If you’re living with Crohn’s and struggling to find an effective therapy, you might qualify for ADVANCE or MOTIVATE – two clinical studies trying to understand if an investigational drug (a drug that is not yet approved for this condition) could be safe and effective in treating Crohn’s disease.
If you qualify and choose to take part, all study-related care and treatment are provided at no cost to you. You don’t need insurance to participate.
About Crohn’s disease
The symptoms of Crohn’s can be different for each person, but can include fatigue, abdominal pain, prolonged diarrhea (sometimes with bleeding), weight loss, and fever.
While we don’t know exactly what causes Crohn’s disease, we believe it may be caused by a combination of genetics, issues in the immune system, the makeup of microorganisms in the gut, and the environment.
Current conventional drugs
Current conventional drugs (like corticosteroids or immunomodulators) for Crohn’s disease often aim to control inflammation in the gut or tackle specific symptoms. While some people find relief with conventional therapies, others do not.
Biologics are another type of medication that target specific proteins in the body that cause inflammation. Biologics may work for some people with Crohn’s disease, but can lose effectiveness over time. For others, existing biologics may not work at all. That’s why we’re conducting the ADVANCE and MOTIVATE clinical studies – to understand if an investigational drug could be safe and effective in treating Crohn’s disease.
About clinical studies
Clinical studies are carefully designed scientific research trials that explore whether a potential drug (often called an investigational drug) is safe and effective for people to use. Clinical studies may help:
- Develop potential new medications
- Find out if certain medicines are better than others
- Find new uses for already-approved medications
Clinical studies are important because they help us learn more about diseases, how to treat them, and ways to keep people healthy. In fact, without clinical trials and the volunteers who take part, modern medicine would not exist!
People take part in clinical studies for a variety of reasons
Some people appreciate the extra attention from study doctors, while others participate to potentially access treatment that isn’t available to the public.
To protect participants’ health, every clinical study follows a carefully written plan called a protocol. All protocols must be reviewed and approved by scientists, government officials, and other groups of people to make sure they are designed safely and ethically. Before any investigational drug can be used by people, it must go through extensive testing in the lab.
All participants must read and sign an informed consent form, which describes the known risks and benefits, and everything that will happen during the study before they can take part.
Many clinical studies happen over three periods
A screening period to see if potential participants would be a good fit.
A dosing period during which participants would attend regular clinic visits and receive either the investigational drug or a placebo (inactive treatment).
A follow-up period for a final check on their health.
About ADVANCE and MOTIVATE Two new clinical studies for Crohn’s disease
- About the investigational drug
- Who could take part?
- What does taking part involve?
- What else should I know?
The ADVANCE and MOTIVATE clinical studies are part of a research program called IBDiscover. These two studies share the same goal – to learn more about an investigational biologic treatment for Crohn’s disease.
What happens during the ADVANCE and MOTIVATE studies is nearly the same. We simply want to understand if the investigational drug is safe and how it impacts symptoms of Crohn’s disease in two slightly different groups of people.
The ADVANCE clinical study will investigate if and how well the investigational drug works in people with moderately to severely active Crohn’s who have previously tried biologic treatments but still have symptoms, and people who have never used a biologic treatment before but are still unable to control symptoms with conventional therapies.
The MOTIVATE clinical study will look at the investigational drug only in people who have tried biologic treatments in the past but found that they weren’t effective for them.
Take our online questionnaire to see if you might qualify for ADVANCE or MOTIVATE.
Studying an investigational treatment for Crohn’s disease
Conventional drugs for Crohn’s disease often aim to control inflammation in the gut or tackle specific symptoms. While some people find relief with these conventional therapies, others do not.
Biologic drugs (sometimes called biologics) are one alternative to conventional therapies. Biologics work by targeting specific proteins in the body that cause inflammation. This type of medication sometimes works well for people, but may lose effectiveness over time. For others, existing biologics may not work at all. That’s why we want to learn more about an investigational biologic drug to see if it could be effective for people who have struggled to find a treatment that works for them.
Current conventional drugs
Conventional drugs are typically created by combining specific chemical ingredients. Their chemical structure is usually relatively simple and well-defined.
Biologic drugs are created using living things like microorganisms, or plant or animal cells. Their chemical structure is usually relatively large and complex.
We’re looking for people who, among other things:
- Are between 16 and 80 years old
- Have been diagnosed with Crohn’s disease for at least 3 months
- Currently have active Crohn’s symptoms (for example, abdominal pain or an average of 4 or more bowel movements a day), and
- Have tried biologic therapies for Crohn’s disease, but still have symptoms, or
- Have never tried biologic therapies for Crohn’s disease, but have tried conventional therapies and still have symptoms
If you aren’t sure if these apply to you, please talk with your doctor.
How long are the ADVANCE and MOTIVATE studies?
If you qualify and choose to participate, you could be in the study for up to 49 weeks. During the screening period and dosing period, you would visit a study clinic about once a month, with a final follow-up phone call after 20 weeks.
We would see if the studies could be a good fit for you.Up to 5 weeks
You would take the investigational medication or placebo.Up to 24 weeks
We would call you on the phone for a final check on your health.20 weeks after your final dose
What happens during the study?
If you qualify and decide to take part, you will be randomly assigned to one of three groups.
During the dosing period, you would attend clinic visits about once a month. Here, you would receive infusions or injections of your assigned study drug. What happens during these visits will vary, but may include:
- Physical exams
- Blood samples
You will also have two endoscopies during the study, with the possibility of a third, if necessary.
Neither you nor your study team will know which group you have been assigned to. However, 12 weeks into the dosing, people who have been taking the placebo and whose symptoms have not improved will be switched to the investigational drug for the rest of the study.
If we find the investigational treatment is effective for you, and you qualify, you may be able to take part in a year-long study after your final ADVANCE or MOTIVATE clinic visit. Some people may qualify to switch to this study at week 12 of the dosing period. Others may qualify after week 24 of the dosing period.
If we find the investigational treatment is not effective for you, you will discontinue the study. We will call you on the phone 20 weeks after your final dose to check on your health.
The safety of participants is always the top priority
Before investigational drugs can ever be used by humans in clinical studies, investigational drugs have gone through extensive testing in a lab. In fact, the investigational drug in ADVANCE and MOTIVATE has already been through many rounds of clinical trials.
However, there is no guarantee the investigational drug will be safe or effective in people with Crohn’s disease. Your health may stay the same, it may improve, or it may get worse. If your health gets significantly worse, your study team will decide what’s best to keep you safe. This might mean stopping your participation in the study.
To protect participants’ health, every clinical study follows a carefully written plan called a protocol. All protocols must be reviewed and approved by scientists, government officials, and other groups of people to make sure studies are designed safely and ethically.
Taking part in a clinical study is completely voluntary
You never have to take part if you don’t want to. And even if you qualify and decide to take part, you can change your mind and leave at any time. This will have no impact on your usual healthcare.
Of course, taking part is a very personal decision. You are welcome (and encouraged!) to discuss the study with your doctor and loved ones before deciding to participate.
All study-related care and treatment will be provided at no cost
You don’t need insurance to participate. Your travel to and from visits will also be covered.
Frequently asked questions
Whether or not you’ve taken part in a clinical study before, you might have a lot of questions. If you’d like to discuss anything not covered here, please contact our call center at (844) 563-4060.
- How will I know if I qualify?
If it looks like you might be a good fit based on the questionnaire, someone from our call center will contact you and ask a few more questions. If you qualify, you will be asked to schedule an appointment at a study clinic where the study team will complete several assessments to see if you can be enrolled in the study.
- Should I talk to my doctor before participating?
Please do. Taking part in a clinical study is a very personal decision and only you can make the ultimate choice to participate. However, you are more than welcome to discuss the study with your doctor and/or family. If your doctor would like more information, please share this website with them.
- What is a placebo?
In some clinical studies, a placebo is given to a group of people instead of the active (real) investigational drug.
A placebo looks exactly like the investigational drug, but does not contain any active ingredients. This helps scientists know if any changes in your health are due to the investigational drug and not something else.
In the ADVANCE and MOTIVATE studies, neither participants nor their study team know whether they are taking the investigational drug or the placebo.
- Do I have to pay to participate?
No. All study-related care and medication are provided to you at no cost throughout your time on the study. You do not need insurance or a referral to take part. Additional costs like transportation and parking will also be covered.