NCT00642902

A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)

A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course

• 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

To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Atacicept	Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
DRUG	Atacicept	Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
DRUG	Atacicept	Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
DRUG	Placebo matched to atacicept	Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-03-25
• Last updated: 2016-05-24
• Results posted: 2016-05-24

Locations

50 sites across 17 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Lebanon, Lithuania, Netherlands, Russia, Spain, Sweden, Switzerland, Ukraine, United Kingdom