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Completed

NCT Number: NCT01031836

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

20 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI-545

Drug

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-545 600

Drug

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.

Primary outcomes

  1. Number of Participants With Each Category of Adverse Events in Stage I

    Time frame: Stage I (up to 1 year)

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

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

Secondary outcomes

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

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

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

    Time frame: After first dose in Stage I

    Summary of area under the concentration-time curve from zero to Day 14.

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

    Time frame: After first dose in Stage I

  4. Change From Baseline in 21-gene Signature Fold Change in Stage I

    Time frame: Stage I

    21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.

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

    Time frame: Stage I

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • MedImmune LLC

Registry information

Official study title

A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)

Important dates

Study start
2009
Primary completion
2012
Study completion
2016
First posted
Dec 15, 2009
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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