Questions about these Crohn’s disease studies

You may also have specific questions about these Crohn’s disease trials. If you qualify for an ozanimod study 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 the investigational medication ozanimod is safe and effective for the treatment of moderately to severe active Crohn’s disease.

You will receive either the investigational medication (ozanimod) or placebo (a pill without ozanimod). Two out of every three participants in the Induction studies will receive ozanimod.

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 the investigational treatment for the disease, and those not. The placebo group helps show whether changes seen in the ozanimod group result from the treatment, or occur by chance.

No, ozanimod is not a biologic. It is not a steroid or classical immunosuppressant. Ozanimod is an oral investigational medication that 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 (ozanimod) or placebo (a pill without ozanimod). Neither you nor the study doctor will know whether you are taking placebo or ozanimod. Once the trial results are available, you will learn which treatment you were assigned (ozanimod or placebo).

Ozanimod 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 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 (ozanimod 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.

Celgene Corporation is sponsoring this study. Headquartered in Summit, New Jersey, Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. For more information, please visit www.celgene.com.

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) 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.