Study identifier:CD-IA-MEDI-545-1067
ClinicalTrials.gov identifier:NCT01283139
EudraCT identifier:2010-024069-30
CTIS identifier:N/A
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Phase 2
No
-
All
834
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2018 by MedImmune, LLC
MedImmune, LLC
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Sifalimumab 200 milligram (mg) Sifalimumab 200 milligram (mg) will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. | Biological/Vaccine: 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. Other Name: MEDI-545 |
Experimental: Sifalimumab 600 mg Sifalimumab 600 mg will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. | Biological/Vaccine: 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. Other Name: MEDI-545 |
Experimental: Sifalimumab 1,200 mg Sifalimumab 1,200 mg will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. | Biological/Vaccine: 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 Name: MEDI-545 |
Placebo Comparator: Placebo Placebo matching to sifalimumab will be administered intravenously at a fixed dose 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 |