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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.

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MEDI-545
MEDI-545
MEDI-545
MEDI-545
MEDI-545
MEDI-545 600
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, Japanese, phase 2, safety, tolerability, MEDI-545, Autoimmune Disease, Immune System Diseases

Eligibility Criteria

20 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

MEDI-545 1.0 mg/kg

MEDI-545 3.0 mg/kg

MEDI-545 10.0 mg/kg

MEDI-545 100 mg

MEDI-545 600 mg

MEDI-545 1,200 mg

Arm Description

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Outcomes

Primary Outcome Measures

Number of Participants With Each Category of Adverse Events in Stage I
Number of Participants in Each Category of Adverse Events (AE) in Stage II

Secondary Outcome Measures

Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
AUC0-14 of MEDI-545 After First Dose in Stage I
Summary of area under the concentration-time curve from zero to Day 14.
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
Change From Baseline in 21-gene Signature Fold Change in Stage I
21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I

Full Information

First Posted
December 11, 2009
Last Updated
May 9, 2018
Sponsor
AstraZeneca
Collaborators
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01031836
Brief Title
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 25, 2009 (Actual)
Primary Completion Date
November 7, 2012 (Actual)
Study Completion Date
July 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
MedImmune LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus, Japanese, phase 2, safety, tolerability, MEDI-545, Autoimmune Disease, Immune System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEDI-545 1.0 mg/kg
Arm Type
Experimental
Arm Description
Cohort 1
Arm Title
MEDI-545 3.0 mg/kg
Arm Type
Experimental
Arm Description
Cohort 2
Arm Title
MEDI-545 10.0 mg/kg
Arm Type
Experimental
Arm Description
Cohort 3
Arm Title
MEDI-545 100 mg
Arm Type
Experimental
Arm Description
Cohort 4
Arm Title
MEDI-545 600 mg
Arm Type
Experimental
Arm Description
Cohort 5
Arm Title
MEDI-545 1,200 mg
Arm Type
Experimental
Arm Description
Cohort 6
Intervention Type
Drug
Intervention Name(s)
MEDI-545
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
MEDI-545
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
MEDI-545
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
MEDI-545
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
MEDI-545
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
MEDI-545 600
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Each Category of Adverse Events in Stage I
Time Frame
Stage I (up to 1 year)
Title
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 Measure Information:
Title
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)
Title
AUC0-14 of MEDI-545 After First Dose in Stage I
Description
Summary of area under the concentration-time curve from zero to Day 14.
Time Frame
After first dose in Stage I
Title
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
Time Frame
After first dose in Stage I
Title
Change From Baseline in 21-gene Signature Fold Change in Stage I
Description
21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.
Time Frame
Stage I
Title
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
Time Frame
Stage I

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsutomu Takeuchi
Organizational Affiliation
Department of Internal Medicine School of Medicine Keio University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoshiya Tanaka
Organizational Affiliation
The University Hospital, University of Occupational and Environmental Health, Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Research Site
City
Kanazawa-shi
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Research Site
City
Kawagoe-shi
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Research Site
City
Kitakyushu-shi
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
060-8638
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan

12. IPD Sharing Statement

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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.

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