A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: MEDI-545; Drug: MEDI-545 600

• Registration Number: NCT01031836
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-25
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-13
• Study First Posted: 2009-12-15
• Primary Completion: 2012-11-07
• Study Completion: 2016-07-11
• Results First Submitted: 2017-07-11
• Status Verified: 2018-03
• Results First Submitted QC: 2018-05-09
• Last Update Submitted: 2018-05-09
• Results First Posted: 2018-11-19
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDI-545 3.0 mg/kg	MEDI-545	Cohort 2
MEDI-545 100 mg	MEDI-545	Cohort 4
MEDI-545 600 mg	MEDI-545 600	Cohort 5
MEDI-545 10.0 mg/kg	MEDI-545	Cohort 3
MEDI-545 1.0 mg/kg	MEDI-545	Cohort 1
MEDI-545 1,200 mg	MEDI-545	Cohort 6

Primary Outcome Measures

Name	Time	Method
Number of Participants in Each Category of Adverse Events (AE) in Stage II	Stage II (1 year to 3.5 years after first dose)
Number of Participants With Each Category of Adverse Events in Stage I	Stage I (up to 1 year)

Secondary Outcome Measures

Name	Time	Method
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	Summary of area under the concentration-time curve from zero to Day 14.
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I	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	21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Shinjuku-ku, Japan