NCT01464905

Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

A Phase 3, Multicenter, Double-blind,Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of NU100 in Patients With Relapsing Forms of Multiple Sclerosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Nuron Biotech Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active comparator. The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	NU100	0.25 mg SQ, every other day for 12 months
BIOLOGICAL	Placebo	1 mL SQ, every other day for 4 months
BIOLOGICAL	rhIFN beta-1b	0.25 mg SQ, every other day for 12 months

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2011-11-04
• Last updated: 2013-09-23

Locations

12 sites across 12 countries: Belarus, Bulgaria, Croatia, Georgia, Hungary, Italy, Lebanon, Poland, Russia, Serbia, Spain, Ukraine