search
Back to results

Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MEDI-546
MEDI-546
MEDI-546
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 Japan, Phase2, Safety, Tolerability, Systemic Lupus Erythematosus, SLE, MEDI-546

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
  • Weight greater than or equal to 40.0 kg.
  • Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening.
  • Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives.
  • Active moderate to severe SLE disease based on SLE disease activity score.

Exclusion Criteria:

  • Active severe or unstable neuropsychiatric SLE.
  • Active severe SLE-driven renal disease or unstable renal disease.
  • Clinically significant active infection including ongoing and chronic infections.
  • Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection.
  • Confirmed positive tests for hepatitis B or positive test for hepatitis C.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

MEDI-546 100 mg IV

MEDI-546 300 mg IV

MEDI-546 1000 mg IV

Outcomes

Primary Outcome Measures

Overall Summary of Adverse Events

Secondary Outcome Measures

Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax
Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast
Anti-drug Antibody (ADA)
MEDI-546 antibody detection measured by electrochemiluminescence (ECL).

Full Information

First Posted
March 19, 2012
Last Updated
March 12, 2019
Sponsor
AstraZeneca
Collaborators
MedImmune LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01559090
Brief Title
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
Official Title
A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2012 (Actual)
Primary Completion Date
August 19, 2014 (Actual)
Study Completion Date
February 21, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
Detailed Description
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Japan, Phase2, Safety, Tolerability, Systemic Lupus Erythematosus, SLE, MEDI-546

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MEDI-546 100 mg IV
Arm Title
2
Arm Type
Experimental
Arm Description
MEDI-546 300 mg IV
Arm Title
3
Arm Type
Experimental
Arm Description
MEDI-546 1000 mg IV
Intervention Type
Drug
Intervention Name(s)
MEDI-546
Intervention Description
Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
Intervention Type
Drug
Intervention Name(s)
MEDI-546
Intervention Description
Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
Intervention Type
Drug
Intervention Name(s)
MEDI-546
Intervention Description
Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.
Primary Outcome Measure Information:
Title
Overall Summary of Adverse Events
Time Frame
Stage I (up to 48 weeks)
Secondary Outcome Measure Information:
Title
Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax
Time Frame
Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
Title
Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast
Time Frame
Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
Title
Anti-drug Antibody (ADA)
Description
MEDI-546 antibody detection measured by electrochemiluminescence (ECL).
Time Frame
Stage I (up to Week 48)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE. Weight greater than or equal to 40.0 kg. Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening. Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives. Active moderate to severe SLE disease based on SLE disease activity score. Exclusion Criteria: Active severe or unstable neuropsychiatric SLE. Active severe SLE-driven renal disease or unstable renal disease. Clinically significant active infection including ongoing and chronic infections. Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection. Confirmed positive tests for hepatitis B or positive test for hepatitis C.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta Weiss, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Research Site
City
Ota-ku
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Research Site
City
Shimotsuke-shi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.

We'll reach out to this number within 24 hrs