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A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01031836
First Posted: December 15, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.

Condition Intervention Phase
Systemic Lupus Erythematosus Drug: MEDI-545 Drug: MEDI-545 600 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The safety and tolerability of MEDI-545 will be assessed primarily by summarizing AEs and SAEs including abnormalities in vital signs and laboratory tests and by assessing changes in viral cultures. [ Time Frame: Through Study Day 1777 ]

Secondary Outcome Measures:
  • The PK, IM and PD of single and multiple IV doses and SC doses of MEDI-545. [ Time Frame: Through Study Day 1777 ]

Enrollment: 42
Study Start Date: November 2009
Study Completion Date: July 2016
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-545 1.0 mg/kg
Cohort 1
Drug: MEDI-545

Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Experimental: MEDI-545 3.0 mg/kg
Cohort 2
Drug: MEDI-545

Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses

Experimental: MEDI-545 10.0 mg/kg
Cohort 3
Drug: MEDI-545

Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Experimental: MEDI-545 100 mg
Cohort 4
Drug: MEDI-545

Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.

Experimental: MEDI-545 600 mg
Cohort 5
Drug: MEDI-545 600

Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.

Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.

Experimental: MEDI-545 1,200 mg
Cohort 6
Drug: MEDI-545

Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.

Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have previously met ≥4 of the 11 revised ACR criteria
  • Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening
  • Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥6

Exclusion Criteria:

  • Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)
  • Have received the following medications within 28 days before Visit 2 (Day 1):

    • Systemic cyclophosphamide at any dose
    • Cyclosporine at any dose
    • Tacrolimus at any dose
    • Thalidomide at any dose
    • Mycophenolate mofetil >2 g/day
    • Methotrexate >15 mg/week
    • Azathioprine >2 mg/kg/day
  • Women who have a positive pregnancy test (serum hCG) at Visit 1
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031836


Locations
Japan
Research Site
Chiba-shi, Japan
Research Site
Fukuoka-shi, Japan
Research Site
Kanazawa-shi, Japan
Research Site
Kawagoe-shi, Japan
Research Site
Kitakyushu-shi, Japan
Research Site
Sapporo-shi, Japan
Research Site
Shinjuku-ku, Japan
Sponsors and Collaborators
AstraZeneca
MedImmune LLC
Investigators
Principal Investigator: Tsutomu Takeuchi Department of Internal Medicine School of Medicine Keio University
Principal Investigator: Yoshiya Tanaka The University Hospital, University of Occupational and Environmental Health, Japan
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01031836     History of Changes
Other Study ID Numbers: D2800C00001
First Submitted: December 11, 2009
First Posted: December 15, 2009
Last Update Posted: October 12, 2017
Last Verified: July 2016

Keywords provided by AstraZeneca:
Systemic Lupus Erythematosus
Japanese
phase 2
safety
tolerability
MEDI-545
Autoimmune Disease
Immune System Diseases

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs