Crohn's Disease Study
This investigation consists of three studies.
The purpose of this study is to study whether ozanimod is a safe and effective treatment for moderate to severe Crohn’s disease.
The purpose of this study is to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn’s Disease.
The purpose of this study is to demonstrate the long-term safety and explore long-term efficacy of ozanimod for the treatment of moderately to severely active Crohn’s Disease.
This research study is led by Dr. Rohit Singhania.
Contact: Jessica Vegerano, 413-794-3097
Primary Sponsor: Celgene International II Sarl
December 15, 2020
1568660 (Induction), 1568663 (Maintenance), 1568673 (Open-Label)
Baystate Medical Center, 759 Chestnut Street, Springfield, MA
- Subjects aged 18 to 75 years (at Screening)
- Subject has signs and symptoms consistent with a diagnosis of CD for at least 3 months (prior to first IP administration). The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histology report.
- Subject fulfilled the inclusion criteria at time of entry into the Induction Study (RPC01-3201 or RPC01-3202) and has completed the Week 12 efficacy assessments of the Induction Study.
- Subjects who have met the discontinuation criteria in the Induction Study.
- Subjects who are not in clinical response and /or clinical remission after completing 12 weeks I the Induction Studies RPC01-3201 or RPC01-3202, subjects who experience relapse in the Maintenance Study RPC01-3203, subjects who complete the Maintenance Study RPC01-3203, subjects who complete at least 1 year of RPC01-2201.
Induction Study 12 weeks, Maintenance Study 52 weeks, Open-Label Study up to 48 months.