A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE)

MedImmune LLC21 sites in 2 countries45 target enrollmentMarch 2006

ConditionsLupus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Lupus
Sponsor: MedImmune LLC
Enrollment: 45
Locations: 21
Primary Endpoint: Safety and tolerability of MEDI-545 will be assessed primarily by summarizing adverse events.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid.

Detailed Description

The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients who have SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid. The secondary objective of this study is to describe the pharmacokinetics and potential immunogenicity of MEDI-545.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

October 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MedImmune LLC

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following criteria:
•Adult males and females ≥ 18 years at the time of the first dose of study drug.
•Written informed consent obtained from the patient/patient's legal guardian
•Diagnosis of SLE: Patients must have previously met ≥ 4 of the 11 revised ACR criteria
•Current background treatments may include the following medications prior to randomization: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and antimalarials, such as hydroxychloroquine ≤ 600 mg/day, and prednisone ≤ 20 mg daily (or an equivalent dose of another oral corticosteroid) for at least 28 days
•Sexually active females, unless surgically sterile or at least two years post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 28 days before the first dose of study drug, and must agree to continue using such precautions through the study period of 84 days. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through Study Day
•Ability to complete follow-up period of 84 days as required by the protocol.

Exclusion Criteria

•Weight ≥ 120 kg
•Use of cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil or cyclosporine within 28 days before study entry
•Use of doses of corticosteroids higher than the equivalent of prednisone 20 mg/day (or an equivalent dose of another corticosteroid) within 28 days before study entry
•In the opinion of the investigator, a likelihood of requiring initiation of immunosuppressant therapy (e.g., prednisone \>20 mg daily (or an equivalent dose of another oral corticosteroid), azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, or dapsone) within the 28 days after study entry. Antimalarial dosing must be held constant during the study, but analgesics and NSAIDs may be varied.
•Current treatment with coumadin
•Treatment with immunoglobulin or blood products within 28 days before entry into the study
•Treatment with any investigational drug therapy within 28 days before entry into the study; in the case of cell-depleting therapies, such as B or T cell depletion, cell counts that remain below acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted)
•History of primary immunodeficiency
•History of allergic reactions likely to be exacerbated by any component of the study drug
•Previous medical history, or evidence, of an intercurrent illness, other than SLE, that may compromise the safety of the patient in the study