NCT01559090

Brief Summary

The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

April 20, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2014

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 13, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

2.3 years

First QC Date

March 19, 2012

Results QC Date

February 6, 2018

Last Update Submit

March 12, 2019

Conditions

Systemic Lupus Erythematosus

Keywords

JapanPhase2SafetyTolerabilitySystemic Lupus ErythematosusSLE, MEDI-546

Outcome Measures

Primary Outcomes (1)

  • Overall Summary of Adverse Events

    Stage I (up to 48 weeks)

Secondary Outcomes (3)

  • Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax

    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

  • Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast

    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

  • Anti-drug Antibody (ADA)

    Stage I (up to Week 48)

Study Arms (3)

1

EXPERIMENTAL

MEDI-546 100 mg IV

Drug: MEDI-546

2

EXPERIMENTAL

MEDI-546 300 mg IV

Drug: MEDI-546

3

EXPERIMENTAL

MEDI-546 1000 mg IV

Drug: MEDI-546

Interventions

MEDI-546DRUG

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

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Chiba, 260-8677, Japan

Location

Research Site

Chūōku, 104-8560, Japan

Location

Research Site

Ōta-ku, 143-8541, Japan

Location

Research Site

Sendai, 980-8574, Japan

Location

Research Site

Shimotsuke-shi, 329-0498, Japan

Location

Research Site

Shinjuku-ku, 160-8582, Japan

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Clinical Study Information Center
Organization
AstraZeneca
information.center@astrazeneca.com
1-877-240-9479

Study Officials

  • Roberta Weiss, MD

    MedImmune LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

April 20, 2012

Primary Completion

August 19, 2014

Study Completion

February 21, 2017

Last Updated

March 13, 2019

Results First Posted

March 13, 2019

Record last verified: 2019-03

Locations

JP(6)