An Open-label Study to Evaluate the Long-term Safety of MEDI-546, a Product Under Investigation for the Treatment of Systemic Lupus Erythematosus, in Adults

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01753193
First received: December 17, 2012
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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: 2 years ] [ Designated as safety issue: Yes ]
    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: 2 years ] [ Designated as safety issue: Yes ]
    Immunogenicity will be measured by laboratory assessments looking for anti-drug antibodies


Estimated Enrollment: 240
Study Start Date: March 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01753193

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
Palm Desert, California, United States
Research Site
Upland, California, United States
United States, Florida
Research Site
Orlando, Florida, United States
United States, Georgia
Research Site
Stockbridge, Georgia, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, New York
Research Site
New York, New York, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
United States, Oklahoma
Research Site
Tulsa, Oklahoma, United States
United States, Texas
Research Site
Houston, Texas, United States
Colombia
Research Site
Barranquilla, Colombia
Research Site
Bogota, Colombia
Research Site
Bucaramanga, Colombia
Research Site
Chia, Colombia
Research Site
Medellin, Colombia
Korea, Republic of
Research Site
Gwangju, Korea, Republic of
Research Site
Seodaemun-gu, Korea, Republic of
Mexico
Research Site
Guadalajara, Mexico
Research Site
Leon, Mexico
Research Site
Mexico, Mexico
Research Site
Toluca, Mexico
Peru
Research Site
Arequipa, Peru
Research Site
Lima, Peru
Sponsors and Collaborators
MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01753193     History of Changes
Other Study ID Numbers: CD-IA-MEDI-546-1145, 2012-004619-30
Study First Received: December 17, 2012
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Colombia: National Institutes of Health
Czech Republic: State Institute for Drug Control
Mexico: Ministry of Health
Peru: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Ukraine: Ministry of Health

Keywords provided by MedImmune LLC:
Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014