RPC1063

DRUG6 trials

Conditions

Crohn's DiseaseHealthy VolunteersMultiple SclerosisUlcerative Colitis

Phase 1

Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

CompletedNCT02797015

CelgeneMultiple Sclerosis

Start: 2016-06-23End: 2017-10-20Updated: 2018-03-27

A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults

CompletedNCT02994381

CelgeneHealthy Volunteers

Start: 2016-10-31End: 2016-11-30Updated: 2017-01-27

Phase 2

Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease

CompletedNCT02531113

CelgeneCrohn's Disease

Start: 2015-10-09End: 2019-11-28Updated: 2021-01-22

Phase 3

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

CompletedNCT02435992

CelgeneUlcerative Colitis

Start: 2015-06-17End: 2020-06-17Updated: 2021-09-01

An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

CompletedNCT02531126

CelgeneUlcerative Colitis

Start: 2015-12-02End: 2024-12-19Updated: 2025-12-31

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

CompletedNCT02576717

CelgeneMultiple Sclerosis

Start: 2015-10-16End: 2023-01-05Updated: 2024-01-30

2026-03-27

Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis.

2026-02-12

Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid.

2026-01-01

Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension trial.

2025-11-05

Brain atrophy and associations with long-term disability and cognitive function in participants with relapsing multiple sclerosis treated with ozanimod: Results from phase 3 and open-label extension trials

Multiple Sclerosis Journal2025-07-23

Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis.

2025-04-012 citations

Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial

The American Journal of Gastroenterology2025-01-082 citations

Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies

Clinical Gastroenterology and Hepatology2024-05-0816 citations

Absolute Lymphocyte Count Around Infections During Phase 3 and Open-label Extension Trials of Ozanimod in Participants with Relapsing Multiple Sclerosis (P10-6.013)

Neurology2024-04-09

Ozanimod Differentially Impacts Circulating Lymphocyte Subsets in Patients with Moderately to Severely Active Crohn’s Disease

Digestive Diseases and Sciences2024-04-037 citations

New progress of small-molecule drugs in the treatment of inflammatory bowel disease

Chinese Medical Journal2024-01-251 citations

DOP16 Safety of long-term ozanimod treatment for up to 4 years in patients with moderately to severely active Ulcerative Colitis: an interim analysis of the True North open-label extension

Journal of Crohn s and Colitis2024-01-014 citations

P653 Impact of ozanimod on type III collagen turnover biomarkers and the association with ozanimod efficacy in patients with moderately to severely active ulcerative colitis: Results from the phase 3 True North study

Journal of Crohn s and Colitis2024-01-011 citations

P545 Long-term efficacy of ozanimod up to 3 years in patient response subgroups identified using group-based trajectory modelling

Journal of Crohn s and Colitis2024-01-011 citations

P637 Ozanimod efficacy with or without concomitant corticosteroids in 5-ASA–exposed, advanced therapy–naive, immunomodulator-naive patients with ulcerative colitis: a post hoc analysis of True North

Journal of Crohn s and Colitis2024-01-01

P789 Impact of risk factors for Janus kinase inhibitor use identified by the Pharmacovigilance Risk Assessment Committee on the safety and efficacy of ozanimod in patients with moderately to severely active ulcerative colitis

Journal of Crohn s and Colitis2024-01-01

P567 Impact of recent thiopurine use on ozanimod safety in patients with ulcerative colitis: a post hoc analysis of the phase 3 True North study

Journal of Crohn s and Colitis2024-01-01

Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial

Multiple Sclerosis Journal2023-12-214 citations

Cardiovascular Safety of Ozanimod in Patients With Ulcerative Colitis: True North and Open-Label Extension Analyses.

2023-11-3014 citations

S901 Group-Based Trajectory Modeling to Identify Response Patterns to Ozanimod Treatment in Patients With Ulcerative Colitis

The American Journal of Gastroenterology2023-10-011 citations

31 more papers not shown

RPC1063

Sponsors

Conditions

Phase 1

Phase 2

Phase 3

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