The YELLOWSTONE Program is a series of Phase 3 clinical studies for people with moderately to severely active Crohn’s disease. These studies will evaluate the safety and effectiveness of an oral investigational study drug (ozanimod) which is taken once daily. Ozanimod is not a biologic, injection or infusion. Ozanimod is an immune regulator designed to change the body’s immune system response (when the body defends itself), potentially reducing inflammation and overall disease activity. The goal is to potentially help people living with this disease reduce symptoms (remission/response).
The YELLOWSTONE Program is made up of four clinical studies:
- The Induction 1 and 2 studies are the first phase 3 studies and are currently accepting new Crohn’s disease patients. Participation in these clinical studies is expected to last 12 weeks (3 months).
- Depending on response and the study doctor’s recommendation, participants may have the opportunity to continue participation in the YELLOWSTONE Maintenance or YELLOWSTONE Open-Label Extension Studies
For each study, patients can expect to have visits with a doctor every 1-3 months. The length of each visit may vary.
Who is eligible to participate in the YELLOWSTONE Program?
Crohn’s disease patients may be eligible to participate in these clinical studies if they:*
- Are 18 to 75 years of age
- Have been experiencing signs and symptoms of CD for at least 3 months where the diagnosis has been confirmed by endoscopy (a procedure where a doctor looks inside your digestive tract using a device called an endoscope).
- Have not improved on or have not been able to tolerate, at least one prior Crohn’s disease medication such as corticosteroids, immunomodulators, or biologic therapy (e.g., ustekinumab, TNFα antagonists or vedolizumab)
* Other eligibility criteria apply
Only a study doctor can determine if a person meets all eligibility criteria.
To learn more about the YELLOWSTONE Program of studies visit:
Induction Study 1: http://bit.ly/NCT03440372
Induction Study 2: http://bit.ly/NCT03440385
Is the YELLOWSTONE clinical trial available in my country?
There are YELLOWSTONE clinical trial sites around the world. For more information on clinical trial sites in the countries listed below, visit ClinicalTrials.gov or crohnsstudies.com websites https://morbuscrohn-studie.de (for Germany, Austria, Switzerland), https://crohns-study.co.uk (for the UK) and https://chorobacrohna-badanie.pl (for Poland), or email Clinical.Trials@bms.com.