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.
You may be able to take part in one of these studies if you*:
*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.
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.
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.
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:
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.
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. |
YELLOWSTONE includes two phase 3 clinical trials, Induction 1 and Induction 2, that are currently accepting patients.
Talk to your doctor about the risks and benefits of taking part in a clinical research study.
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.
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.
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.