NCT02576717

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

A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,494 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

Detailed description

The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	RPC1063

Timeline

• Start date: 2015-10-16
• Primary completion: 2023-01-05
• Completion: 2023-01-05
• First posted: 2015-10-15
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

175 sites across 26 countries: United States, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Estonia, Georgia, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Moldova, New Zealand, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom