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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.

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.
 
ClinicalTrials.gov Identifier: NCT01031836
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: MEDI-545 Drug: MEDI-545 600 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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)
Actual Study Start Date : November 25, 2009
Actual Primary Completion Date : November 7, 2012
Actual Study Completion Date : July 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
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





Primary Outcome Measures :
  1. Number of Participants With Each Category of Adverse Events in Stage I [ Time Frame: Stage I (up to 1 year) ]
  2. Number of Participants in Each Category of Adverse Events (AE) in Stage II [ Time Frame: Stage II (1 year to 3.5 years after first dose) ]

Secondary Outcome Measures :
  1. Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I [ Time Frame: After first dose in Stage I (0 upto 28 days) ]
  2. AUC0-14 of MEDI-545 After First Dose in Stage I [ Time Frame: After first dose in Stage I ]
    Summary of area under the concentration-time curve from zero to Day 14.

  3. Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I [ Time Frame: After first dose in Stage I ]
  4. Change From Baseline in 21-gene Signature Fold Change in Stage I [ Time Frame: Stage I ]
    21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.

  5. Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I [ Time Frame: Stage I ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 130 Years   (Adult, Older Adult)
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

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
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Japan
Research Site
Chiba-shi, Japan, 260-8712
Research Site
Fukuoka-shi, Japan, 810-8563
Research Site
Kanazawa-shi, Japan, 920-8650
Research Site
Kawagoe-shi, Japan, 350-8550
Research Site
Kitakyushu-shi, Japan, 807-8555
Research Site
Sapporo-shi, Japan, 060-8638
Research Site
Shinjuku-ku, Japan, 160-8582
Sponsors and Collaborators
AstraZeneca
MedImmune LLC
Investigators
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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
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01031836    
Other Study ID Numbers: D2800C00001
First Posted: December 15, 2009    Key Record Dates
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018
Last Verified: March 2018
Keywords provided by AstraZeneca:
Systemic Lupus Erythematosus
Japanese
phase 2
safety
tolerability
MEDI-545
Autoimmune Disease
Immune System Diseases
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Sifalimumab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs