Journal
CONTEMPORARY CLINICAL TRIALS
Volume 122, Issue -, Pages -Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2022.106958
Keywords
Crohn's disease; Inflammatory bowel diseases; Ulcerative colitis; Endoscopy; Histopathology
Funding
- Bristol Myers Squibb
Ask authors/readers for more resources
The YELLOWSTONE program aims to evaluate the safety and efficacy of ozanimod in patients with moderately to severely active Crohn's disease through phase 3 trials, including induction, maintenance, and open-label extension studies.
Background: Ozanimod, an oral sphingosine 1-phosphate receptor modulator currently approved for the treat-ment of moderately to severely active ulcerative colitis and relapsing multiple sclerosis, showed clinical, endoscopic, and histological benefit in the phase 2 STEPSTONE trial for Crohn's disease (CD). We aim to describe the trial design of the YELLOWSTONE phase 3 program evaluating the safety and efficacy of ozanimod in patients with moderately to severely active CD.Methods: The YELLOWSTONE program consists of phase 3, randomized, double-blind, placebo-controlled in-duction (NCT03440372 and NCT03440385) and maintenance (NCT03464097) trials and an open-label extension (OLE) study (NCT03467958). Patients with inadequate response or intolerance to >= 1 CD treatment are ran-domized to receive daily ozanimod 0.92 mg (equivalent to ozanimod HCl 1 mg) or placebo for 12 weeks during induction. Those who respond to ozanimod are rerandomized to continue ozanimod or placebo maintenance therapy for 52 weeks. Patients who do not meet criteria for maintenance, experience relapse during maintenance, or complete maintenance or >= 1 year of STEPSTONE are eligible for open-label treatment for up to 234 weeks. Efficacy endpoints include clinical, endoscopic, and histologic outcomes. Results: Expected 2023 (induction studies), 2024 (maintenance study), and 2026 (OLE).Conclusion: YELLOWSTONE will provide pivotal phase 3 data on the safety and efficacy of ozanimod in patients with moderately to severely active CD using state-of-the-art methods, including centrally read endoscopic and histologic measurements, along with subjective assessments of symptom control based on the Crohn's Disease Activity Index. These studies could enable approval of ozanimod as a new CD therapy.Clinical trial registration numbers: NCT03440372, NCT03440385, NCT03464097, NCT03467958
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available