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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: MEDI-545; Drug: MEDI-545 600

Study type: Interventional

Funder types: Industry

Identifiers

NCT01031836

D2800C00001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 130 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

MEDI-545 1.0 mg/kg

Experimental group

Description:

Cohort 1

Treatment:

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

MEDI-545 3.0 mg/kg

Experimental group

Description:

Cohort 2

Treatment:

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

MEDI-545 10.0 mg/kg

Experimental group

Description:

Cohort 3

Treatment:

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

MEDI-545 100 mg

Experimental group

Description:

Cohort 4

Treatment:

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

MEDI-545 600 mg

Experimental group

Description:

Cohort 5

Treatment:

Drug: MEDI-545 600

MEDI-545 1,200 mg

Experimental group

Description:

Cohort 6

Treatment:

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545

Drug: MEDI-545