YELLOWSTONE - Induction Study (RPC01-3202) - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease.
Published: 05/05/2019
General Information:
The primary objective of this study is to evaluate the efficacy of oral ozanimod compared with placebo on the induction of clinical remission.
Eligibility:
Inclusion Criteria:*
You may be able to take part in this ozanimod study if you:
- are 18 to 75 years of age
- have been diagnosed with active Crohn's disease confirmed by endoscopy (a procedure where a doctor looks inside your digestive tract using a device called an endoscope).
- 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†
†Eligible prior medications include corticosteroids, immunomodulators or biologic therapy (e.g., ustekinumab, TNFα antagonists or vedolizumab).
Exclusion Criteria:*
The presence of any of the following will exclude you from participation in the study:
- Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis or known strictures or stenosis leading to symptoms of obstruction.
- Current stoma, connection of your ileal and anal pouch, symptomatic fistula, or need for ileostomy or colostomy
*Other inclusion/exclusion criteria apply
Study Details:
Study Description
YELLOWSTONE Induction Study (RPC01-3202)
- This study is designed to determine the safety and effectiveness of the oral investigational study drug, ozanimod, versus a placebo (an inactive substance) in achieving symptom remission in patients with active Crohn's disease symptoms. An induction study is the first in a series of studies. Participation in this clinical study 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 RPC01-3203 or YELLOWSTONE Open-Label Extension Study (RPC01-3204). An open label extension study means you may be able to continue taking the investigational study drug, if you qualify and choose to participate.
Learn more at www.crohnsstudies.com.
Description of Treatment or Intervention (Mechanism of Action)
Ozanimod is thought to act on the immune system by encouraging certain types of white blood cells called lymphocytes, which include T cells, to stay in the lymph nodes and other places in the body, thereby keeping them away from sites of inflammation.
Lymphocytes, which act as the body's mechanism to fight off invaders, are responsible for initiating the immune response. However, in Crohn's disease, lymphocytes misread the inflammation caused by the disease as an area where their help is needed.
Patient Participation Requirements
- Visits to the trial site will be required approximately every 4 weeks for the Induction study.
- A variety of assessments such as lab tests, ECGs, vital signs, physical exams, eye exams, endoscopies and pulmonary function tests will be performed.
- Participants will need to complete some questionnaires during visits to the trial site, and to keep a study diary (e-diary) daily.
- If you are living with active Crohn's disease and experiencing symptoms, you may want to discuss this study with a participating trial site where the study will be explained to you in greater detail and you will be given an opportunity to ask any questions.
Possible Risks & Side Effects
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 trial, more information will be given to you by the study site doctor or a member of their staff.