A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
This study is currently recruiting participants.
Verified April 2013 by MedImmune LLC
Sponsor:
MedImmune LLC
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01438489
First received: September 9, 2011
Last updated: April 16, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus |
Biological: MEDI-546 Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus |
Resource links provided by NLM:
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- Achievement of response in a systemic lupus erythematosus (SLE) responder index [ Time Frame: Day 169 (or 6 months) ] [ Designated as safety issue: No ]Number and percentage of participants achieving a response in an SLE responder index at Day 169 (or 6 months)
Secondary Outcome Measures:
- Achievement of response in a systemic lupus erythematosus (SLE) responder index [ Time Frame: Day 365 (or 1 year) ] [ Designated as safety issue: No ]Number and percentage of participants achieving a response in an SLE responder index at Day 365 (or 1 year)
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MEDI-546 Low-dose Group
MEDI-546 will be given at the predetermined dosing intervals as specified in the protocol
|
Biological: MEDI-546
Low dose of MEDI-546 administered as an intravenous infusion at the predetermined intervals
|
|
Experimental: MEDI-546 High-dose Group
MEDI-546 will be given at the predetermined dosing intervals as specified in the protocol
|
Biological: MEDI-546
High dose of MEDI-546 administered as an intravenous infusion at predetermined intervals
|
|
Placebo Comparator: Matching Placebo Group
Placebo matching MEDI-546 will be given at the predetermined dosing intervals as specified in the protocol
|
Other: Placebo
Matching placebo to MEDI-546 administered as an intravenous infusion at predetermined intervals
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening
- Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
- Weight greater than or equal to 40 kg
- Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
- Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
- No evidence of cervical malignancy on Pap smear within 2 years of randomization
- Female subjects must be willing to avoid pregnancy
- Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization
Exclusion Criteria:
- Active severe SLE-driven renal disease or unstable renal disease prior to screening
- Active severe or unstable neuropsychiatric SLE
- Clinically significant active infection including ongoing and chronic infections
- History of human immunodeficiency virus (HIV)
- Confirmed Positive tests for hepatitis B or positive test for hepatitis C
- History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
- Live or attenuated vaccine within 4 weeks prior to screening
- Subjects with significant hematologic abnormalities
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438489
Show 68 Study Locations
Contacts
| Contact: Lisa Farace | 301-398-0000 | clinicaltrialenquiries@medimmune.com |
Show 68 Study LocationsSponsors and Collaborators
MedImmune LLC
Investigators
| Study Director: | Stephen Yoo, MD | MedImmune LLC |
More Information
No publications provided
| Responsible Party: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT01438489 History of Changes |
| Other Study ID Numbers: | CD-IA-MEDI-546-1013 |
| Study First Received: | September 9, 2011 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013