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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by AstraZeneca.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
MedImmune LLC
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01031836
First received: December 11, 2009
Last updated: March 17, 2011
Last verified: March 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-545 1.0 mg/kg 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 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 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 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 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 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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031836

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

Locations
Japan
Research Site Recruiting
Chiba, Japan
Research Site Recruiting
Fukuoka, Japan
Research Site Recruiting
Kanazawa, Japan
Researh Site Recruiting
Kawagoe, Japan
Research Site Recruiting
Kitakyushu, Japan
Research Site Recruiting
Sapporo, Japan
Research Site Recruiting
Shinjuku, 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

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01031836     History of Changes
Other Study ID Numbers: D2800C00001
Study First Received: December 11, 2009
Last Updated: March 17, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on April 21, 2014