CLINICAL TRIALS PROFILE FOR OZANIMOD HYDROCHLORIDE
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All Clinical Trials for Ozanimod Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01628393 ↗ | Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients | Completed | Celgene | Phase 2/Phase 3 | 2012-09-18 | This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS). |
| NCT01647516 ↗ | Efficacy and Safety Study of Ozanimod in Ulcerative Colitis | Completed | Celgene | Phase 2 | 2012-12-26 | The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC). |
| NCT02047734 ↗ | Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis | Completed | Celgene | Phase 3 | 2013-12-03 | This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record. The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS). |
| NCT02294058 ↗ | Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS) | Completed | Celgene | Phase 3 | 2014-12-03 | The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS). |
| NCT02531113 ↗ | Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease | Completed | Celgene | Phase 2 | 2015-10-09 | The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease. |
| NCT02531126 ↗ | Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis | Active, not recruiting | Celgene | Phase 3 | 2015-12-02 | This is an open-label, multicenter, extension trial to evaluate the long-term safety and efficacy of RPC1063 in patients with moderately to severely active ulcerative colitis (UC). The purpose of this extension trial is to evaluate the long-term safety and efficacy of RPC1063 in patients with moderately to severely active ulcerative colitis (UC). Only those patients who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible |
| NCT02576717 ↗ | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | Active, not recruiting | Celgene | Phase 3 | 2015-10-16 | The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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