NCT01963611

Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)

A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Plovamer acetate 0.5 milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
DRUG	Copaxone 20 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
DRUG	Plovamer acetate 3 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
DRUG	Plovamer acetate 10 mg	Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
DRUG	Plovamer acetate 20 mg	Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-10-16
• Last updated: 2016-05-11
• Results posted: 2016-05-11

Locations

118 sites across 17 countries: United States, Bulgaria, Croatia, Czechia, Finland, Greece, Hungary, Italy, Mexico, Poland, Russia, Serbia, South Africa, Spain, Turkey (Türkiye), Ukraine, United Kingdom