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An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
MedImmune LLC Identifier:
First received: December 17, 2012
Last updated: August 17, 2017
Last verified: August 2017
The purpose of this study is to evaluate the long-term safety of MEDI-546 in adults with moderate to severe active systemic lupus erythematosus

Condition Intervention Phase
Lupus Erythematosus, Systemic Biological: MEDI-546 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
This is an Open Label Extension study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus

Resource links provided by NLM:

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 3 years ]
    safety and tolerability will be assessed primarily by summarizing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 3 years ]
    Immunogenicity will be measured by laboratory assessments looking for anti-drug antibodies

Enrollment: 218
Actual Study Start Date: March 28, 2013
Estimated Study Completion Date: July 20, 2018
Estimated Primary Completion Date: July 20, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-546
MEDI-546, IV q4wks for 104 weeks
Biological: MEDI-546
MEDI-546, IV q4wks for 104 weeks

Detailed Description:
This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) MEDI-546 in adult subjects with moderately-to-severely active systemic lupus erythematosus (SLE). Subjects must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.

Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be willing to use 2 methods of effective contraception
  • Must have venous access
  • Must be willing to forego participation in other clinical trials for SLE.

Exclusion Criteria:

  • Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
  • Major surgery within 8 weeks before signing ICF
  • Elective major surgery planned during the study period
  • Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day, Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, Oral, SC, or intramuscular methotrexate > 25 mg/week
  • A live or attenuated vaccine within 4 weeks of signing the ICF
  • Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF
  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 identifier: NCT01753193

  Show 57 Study Locations
Sponsors and Collaborators
MedImmune LLC
  More Information

Responsible Party: MedImmune LLC Identifier: NCT01753193     History of Changes
Other Study ID Numbers: CD-IA-MEDI-546-1145
2012-004619-30 ( EudraCT Number )
Study First Received: December 17, 2012
Last Updated: August 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. Additional information can be found on
URL: http://

Keywords provided by MedImmune LLC:
Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017