What is the YELLOWSTONE program?
The YELLOWSTONE clinical research program will help determine whether an investigational oral medication is safe and effective for the treatment of moderately to severely active Crohn’s disease. Having active disease means you are currently experiencing symptoms associated with Crohn’s disease.
- YELLOWSTONE is comprised of several clinical trials.
- The Induction 1 and 2 studies are the first phase 3 studies and are currently accepting new Crohn’s disease patients.
- The Maintenance study will only accept patients who have completed either the Induction 1 or Induction 2 study.
- Crohn’s disease patients may also have the opportunity to enroll in an Open-label study after completing the 12 week Induction study.
- For each study, you can expect to have visits with a doctor every 1-3 months. The length of each visit may vary.
- You may stop participating in the clinical trials at any time.
Who can participate in the YELLOWSTONE Induction 1 and 2 studies?
You may be able to take part in one of these studies if you*:
- are 18 to 75 years of age
- have been diagnosed with active Crohn’s disease confirmed by endoscopy
- currently have symptoms associated with moderately to severely active Crohn’s disease, and
- have not improved on or have not been able to tolerate, at least one prior Crohn’s disease medication†
*Other eligibility criteria apply
†Eligible prior medications include corticosteroids, immunomodulators or biologic therapy.
If you are interested in exploring in one of the studies or would like more information, please complete this form and a clinical trial navigator will contact you within one business day.
A clinical trial navigator will help you connect quickly with the appropriate study team and make sure you get the information you need to explore a clinical study.
What can I expect if I participate?
If you decide to participate in one of the clinical trials, you will be asked to read and sign an informed consent form that states you understand the study and its potential risks and benefits. You will have regular study visits during the time you are in the study, so you will be able to meet with a doctor and discuss your progress.
- You will be asked to come to the study site for tests and assessments to determine whether you qualify for the trial. This visit is called a screening. Some of these tests and assessments may be the same as the ones you have had as part of your regular care.
- If you qualify and agree to participate in the clinical trial, you will be assigned at random to either the investigational oral medication or placebo (a pill without the investigational medication). Two out of every three participants will receive the investigational medication. Neither you nor the study doctor will know whether you are taking the investigational medication or placebo.
- Your study doctor will monitor your symptoms, and you will complete tests and procedures so they can check your health.
Study patients may qualify to enter an open-label extension study if their Crohn’s symptoms have not sufficiently improved or if they complete the maintenance portion of the study.
Speaking with your doctor
If you’re considering participation in a clinical research study, you should speak with your doctor first. Since your physician knows you, your health and your history with Crohn’s disease, he or she can help determine whether a clinical research trial is right for you.
Provide your doctor with information on these studies and ask for their input.
Here are some questions to keep in mind when speaking with your doctor:
- What are the advantages and disadvantages of participating in a clinical research trial?
- Can I only join a study if no other treatments work?
- If I join a study, will I need to see a new doctor?
- Will I be allowed to continue to see you as my doctor if I join a trial?
- What kind of medical support system will I have if I participate in a study?
- Other than one of these studies, what are my other options?
- Will I be able to try other treatments later, even if I enroll in a study?
Questions about these Crohn’s disease studies
You may also have specific questions about these Crohn’s disease studies. If you qualify for one of the studies and decide you may want to enroll, you can have your questions answered by the team conducting the study. You may also want answers from your doctor before making a final decision. Here are some common questions:
These studies will help determine whether an investigational medication is safe and effective for the treatment of moderately to severely active Crohn’s disease.
You will receive either the investigational medication or placebo (a pill without the investigational medication). Two out of every three participants in the Induction studies will receive the investigational oral medication.
The inclusion of a group of participants receiving a placebo in a study is important because it offers a comparison between Crohn’s patients receiving investigational treatment and those who are not. The placebo group helps show whether changes seen in the investigational medication group result from the treatment, or occur by chance.
No, the investigational oral medication is not a biologic. It is not a steroid or classical immunosuppressant. The oral investigational medication is thought to help keep cells that cause inflammation away from parts of the intestine affected by Crohn’s disease.
Once you qualify for the study, it is determined by random chance whether you will receive the investigational medication or placebo (a pill without the investigational medication). Neither you nor the study doctor will know whether you are taking placebo or the investigational oral medication. Once the trial results are available, you will learn which treatment you were assigned to (the investigational medication or placebo).
The oral investigational medication is still being studied, so not all of its side effects are known. In the phase 2 clinical trial, the most common serious adverse events in two or more patients were Crohn’s disease flare, fistulizing disease, intestinal obstruction and abdominal abscess. If you qualify for the study, more information will be given to you by the study site doctor or a member of their staff.
If you qualify for the study, speak with your study site doctor to determine whether you can continue taking your current medications.
The YELLOWSTONE Induction studies, which are currently accepting new Crohn’s disease patients, are expected to last for 12 weeks. At the end of the Induction studies, participants have the choice to enter the Maintenance and/or Open-label studies.
If you qualify for the study, you can expect to have visits to the study site to see the study doctor every 1-3 months. The length of each visit may vary. Speak with your study site doctor for more information.
Your participation in this study is voluntary. You can decide not to take part, or to leave the study at any time. Your decision will not affect your access to future treatment. If you want to leave the study, the study doctor will help you stop taking the investigational medication safely and make arrangements for further medical care and follow-up. You will be asked to attend a study visit so that the study team can complete final assessments of your health.
Yes, once the study results are available, you will be informed by your study site of the findings and which treatment group you were assigned to (the investigational medication or placebo).
Speak with the study site doctor on how best to keep your doctor informed about your participation in the study. Results of the study will be shared by your study site when the study is complete and the data is made available.
Privacy is protected for people involved in a clinical research study. The study doctor will collect information from you that will be labeled with a code. It will be processed without your name, ID number or any other information that reveals your identity. Only authorized people (such as the study doctor and select health authority members) will have access to the list of patient names and any matching codes.
There are no costs to you to take part in the study. The investigational medication, medical care and cost of study-related tests and procedures will be paid for by the study sponsor. You may also be reimbursed for certain expenses, such as travel to and from the study site.
What is a clinical research study and how does it work?
- Clinical research studies, also called clinical trials, look at ways to prevent, diagnose and treat disease.
- These studies are necessary to learn whether an investigational medication is safe and useful to treat a specific disease or condition. Participation in clinical trials enables researchers to better understand the safety and effectiveness of a new investigational medication. This information is necessary to develop new treatment options for people with Crohn’s disease.
- Every study is conducted according to a plan called a protocol. The protocol helps to ensure the safety of participants while also answering specific research questions. The protocol describes:
- who can and cannot participate in the study
- how long participants will be in the study
- what is the dose and administration method of the investigational medication
- what tests and assessments that participants must undergo
- Every protocol is evaluated by an independent committee of people to make sure appropriate measures are in place within the protocol to protect the rights and safety of participants.
- If you decide to take part in a study, the study site doctor or a member of their staff will discuss the protocol with you, and you will need to give your informed consent so that you may participate.
- If you enter, you may decide to withdraw from the study at any time and for any reason.
- Participating in a study means you will be carefully monitored for safety and for disease activity; the monitoring ensures your safety and proper management of the disease.
- In the event of any new or unwarranted symptoms, you will have access to a 24-hour contact phone number to call.
- Once the study results are available, you will be informed by your study site of the findings and which treatment group you were assigned to.
What are the different phases and stages of a clinical study in Crohn’s disease?
- Investigational medicines for Crohn’s disease typically move through four phases of clinical studies that each answer different questions about the medicine:
| Phase | # of Participants | Study Goals |
| Phase 1 | A phase 1 study typically involves about 20 people who are often healthy, or it may include people with Crohn’s disease | A phase 1 study examines how the body responds to a medicine, whether it is safe, and what dose might work best. |
| Phase 2 | A phase 2 study may include dozens of people with Crohn’s disease | A medicine that is determined to be safe can then move into phase 2 to see whether it can help improve symptoms of the disease and whether it causes any short-term side effects. Participants may be randomly assigned to different types of treatments or different dosages of a treatment so their side effects and efficacies can be compared. |
| Phase 3 | A phase 3 study may involve several hundred people with Crohn’s disease | If phase 2 is promising, the medicine can be studied in phase 3 to see how well the investigational medication works compared with either a standard therapy or a placebo. Phase 3 trials often last longer than the first two phases. In most cases, the decision to approve a new medicine to treat Crohn’s disease requires positive results from one or more phase 3 trials. |
| Phase 4 | A phase 4 study may involve thousands of people with Crohn’s disease | After a medicine is approved, a phase 4 study may be done to see how well it works in people who take it in the “real world,” outside a clinical study. The study may last for several years to look for long-term side effects or to better understand how well a new treatment works over a long period of time. |
- Clinical trials involving Crohn’s disease may examine the ability of the investigational medication to control symptoms, called an induction study, or its ability to decrease the frequency of symptom flare-ups following induction, called a maintenance study.
- An induction study is a study to assess whether a medicine can reduce symptoms of a disease compared to a placebo or other treatment. In this study, the induction phase lasts for twelve weeks.
- A maintenance study is characterized by additional treatment following an induction study. The maintenance study is intended to help prevent disease relapse in the patient and assess longer-term benefits of a medicine.
- Often, the same participants may be able to take part in both induction and maintenance studies for the medicine under investigation.
- Many studies are also followed by what’s known as an “open-label extension study,” in which participants can choose to begin or continue taking the investigational medication, typically for a much longer time than in the original clinical study.
YELLOWSTONE includes two phase 3 clinical trials, Induction 1 and Induction 2, that are currently accepting patients.
What are the benefits of participating in a clinical study?
- Clinical research studies are essential in developing treatments to prevent, diagnose or treat diseases. All treatments that have been approved for use by Health Canada today for Crohn’s disease were first studied in clinical trials.
- As a clinical trial volunteer, you belong to a large community of volunteers around the world. You help researchers answer important health questions and help them discover new medical treatments.
- There are no costs to you for taking part in one of these studies. The costs of the investigational medication, study visits and study-related tests and procedures will be paid for by the study sponsor. You may also be reimbursed for certain expenses, such as travel to and from the study site.
What are the risks of participating in a clinical study?
- Patients who participate in a clinical study may not receive any medical benefit.
- You could experience side effects associated with the study drug. The study staff will discuss the known risks in detail with you before you decide to participate.
- You will not be able to choose what treatment you receive. Patients will be randomized (like flipping a coin) to receive either the investigational study drug or placebo (an inactive substance).
What is informed consent?
- Informed consent is a process in which you are given information about a clinical research study so that you can decide whether you want to participate.
- This information includes details about the study’s possible risks and benefits. This process is meant to help you decide whether participation in the study is right for you.
- You will receive an informed consent form that explains the study and gives you this information. Read the form carefully and ask any questions you may have about the study.
- If you agree to be in the study, you will need to sign the informed consent form to show that you understand the study and its possible risks and benefits.
Talk to your doctor about the risks and benefits of taking part in a clinical research study.
What if I change my mind?
- Participation is completely voluntary. You do not have to take part in the study.
- If you choose to participate, you can leave the study at any time and for any reason.
Myth: Patients must complete the study even if their condition gets worse or their health deteriorates.
Fact: Your participation in a study is completely voluntary. Patients may decide to withdraw from a study at any time.
Will I receive a placebo?
- If you qualify and agree to participate in the study, you will be assigned randomly to one of the two treatment groups, and neither you nor the study doctor will know which treatment you will be taking.
- In the Induction studies, there is a 1 in 3 chance you will receive a placebo, a pill that does not contain investigational medication but looks exactly like the investigational medication being tested.
- If your Crohn’s disease symptoms have improved after 12 weeks of treatment, you may have the option to participate in the maintenance study, in which you will receive either the investigational medication or placebo depending on what you were randomized to receive in the Induction study.
- If your Crohn’s symptoms have not sufficiently improved after 12 weeks of treatment, you may have the option to enter an open-label extension study, in which you can receive the investigational medication for up to 1 year.
Myth: Participation in a clinical research trial always means I may get no treatment at all.
Fact: If your Crohn’s symptoms have not sufficiently improved after 12 weeks of treatment, you may have the option to enter an open-label extension study, where you can receive the investigational oral medication.
Will my privacy be protected if I participate in a clinical study?
The study doctor will collect information from you that will be labeled with a code. It will be processed without your name or any other information that reveals your identity. Only authorized people (e.g., the study doctor) will have access to the list of patient names and any matching codes.
Privacy is always protected when patients are involved in a clinical research study.