A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01438489
First received: September 9, 2011
Last updated: April 1, 2014
Last verified: April 2014
  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: 571
Study Start Date: January 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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 87 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Stephen Yoo, MD MedImmune LLC
  More Information

Additional 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 1, 2014
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 April 22, 2014