NCT01031836

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_2

Geographic Reach
1 country

7 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

Study Start

First participant enrolled

November 25, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2012

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2016

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 19, 2018

Completed
Last Updated

November 19, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

December 11, 2009

Results QC Date

July 11, 2017

Last Update Submit

May 9, 2018

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus ErythematosusJapanesephase 2safetytolerabilityMEDI-545Autoimmune DiseaseImmune System Diseases

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Each Category of Adverse Events in Stage I

    Stage I (up to 1 year)

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

    Stage II (1 year to 3.5 years after first dose)

Secondary Outcomes (5)

  • Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I

    After first dose in Stage I (0 upto 28 days)

  • AUC0-14 of MEDI-545 After First Dose in Stage I

    After first dose in Stage I

  • Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I

    After first dose in Stage I

  • Change From Baseline in 21-gene Signature Fold Change in Stage I

    Stage I

  • Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I

    Stage I

Study Arms (6)

MEDI-545 1.0 mg/kg

EXPERIMENTAL

Cohort 1

Drug: MEDI-545

MEDI-545 3.0 mg/kg

EXPERIMENTAL

Cohort 2

Drug: MEDI-545

MEDI-545 10.0 mg/kg

EXPERIMENTAL

Cohort 3

Drug: MEDI-545

MEDI-545 100 mg

EXPERIMENTAL

Cohort 4

Drug: MEDI-545

MEDI-545 600 mg

EXPERIMENTAL

Cohort 5

Drug: MEDI-545 600

MEDI-545 1,200 mg

EXPERIMENTAL

Cohort 6

Drug: MEDI-545

Interventions

MEDI-545DRUG

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.

MEDI-545 1.0 mg/kg
MEDI-545 600DRUG

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.

MEDI-545 600 mg

Eligibility Criteria

Age20 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Chiba, 260-8712, Japan

Location

Research Site

Fukuoka, 810-8563, Japan

Location

Research Site

Kanazawa, 920-8650, Japan

Location

Research Site

Kawagoe-shi, 350-8550, Japan

Location

Research Site

Kitakyushu-shi, 807-8555, Japan

Location

Research Site

Sapporo, 060-8638, Japan

Location

Research Site

Shinjuku-ku, 160-8582, Japan

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAutoimmune DiseasesImmune System Diseases

Interventions

sifalimumab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

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

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

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

December 11, 2009

First Posted

December 15, 2009

Study Start

November 25, 2009

Primary Completion

November 7, 2012

Study Completion

July 11, 2016

Last Updated

November 19, 2018

Results First Posted

November 19, 2018

Record last verified: 2018-03

Locations

JP(7)