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

AstraZeneca logo

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)

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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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