NCT01283139

A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 834 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).

Detailed description

This is a Phase 2b, multinational, multicenter, randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety of three intravenous (IV) treatment regimens of sifalimumab (200, 600, or 1,200 mg) in adult subjects with chronic moderately-to-severely active SLE with an inadequate response to standard of care (SOC) for SLE.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Sifalimumab 200 mg	Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
BIOLOGICAL	Sifalimumab 600 mg	Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
BIOLOGICAL	Sifalimumab 1,200 mg	Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
OTHER	Placebo	IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks

Timeline

• Start date: 2011-03-31
• Primary completion: 2013-11-14
• Completion: 2014-04-17
• First posted: 2011-01-25
• Last updated: 2018-04-19
• Results posted: 2016-07-11

Locations

107 sites across 22 countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, France, Germany, Hungary, India, Italy, Jamaica, Mexico, Netherlands, Peru, Philippines, Poland, Romania, South Africa, Spain, Thailand, United Kingdom