A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
Study identifier:CD-IA-MEDI-546-1013
ClinicalTrials.gov identifier:NCT01438489
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus
Medical condition
Systemic Lupus Erythematosus
Phase
Phase 2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
307
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 09 Jan 2012
Primary Completion Date: 08 Apr 2015
Study Completion Date: 08 Apr 2015
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2022 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Anifrolumab (MEDI-546) 300 mg Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. | Biological/Vaccine: Anifrolumab 300 mg Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. Other Name: MEDI-546 |
| Experimental: Anifrolumab (MEDI-546) 1000 mg Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. | Biological/Vaccine: Anifrolumab 1000 mg Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. Other Name: MEDI-546 |
| Placebo Comparator: Matching Placebo Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks. | Other: Placebo Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks. |
Contacts
Investigators
Principal Investigator
Warren Greth
MedImmune
