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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014