A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Clinical Trial Details

YELLOWSTONE Induction Study (RPC01-3201): 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

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.

Key Eligibility:

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
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).

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.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Fatiha Chabouni
(212) 746-5109
fac2005@med.cornell.edu

Primary Investigator(s)

Saya Segal, MD (UES)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1802018961

ClinicalTrials.gov:

NCT03440372

Status

Open to Enrollment

Age Group

Adult

Disease

Crohn's Disease

Inflammatory Bowel Disease