A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

Genentech, Inc.0 sites60 target enrollmentFebruary 2007

ConditionsSystemic Lupus Erythematosus

DrugsrhuMAb IFNalpha

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Systemic Lupus Erythematosus
Sponsor: Genentech, Inc.
Enrollment: 60
Primary Endpoint: The incidence and nature of laboratory abnormalities
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For patients with reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) throughout their participation in the study
•Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria
•Disease duration of ≥ 1 year (after first diagnosis by a physician)
•Current immunity to measles, mumps, rubella, and varicella, as evidenced by positive IgG titers at the time of screening
•Current vaccination against influenza unless contraindicated in the investigator's judgment
•Normal Pap smear within the applicable time interval recommended by current American Cancer Society guidelines

Exclusion Criteria

•Presence of active lupus nephritis
•Presence of active central nervous system (CNS) disease requiring treatment with high-dose corticosteroids or immunosuppressive agents
•Presence of active vasculitis requiring treatment
•History of arterial or venous thromboses within 12 months of screening
•Moderate to severe anemia, thrombocytopenia, or neutropenia
•Any manifestation likely to require, in the investigator's judgment, treatment with high-dose corticosteroids or the addition of an immunosuppressive regimen during the course of the trial
•Pregnancy or lactation
•Lack of peripheral venous access
•History of alcohol or substance abuse within 6 months of screening
•History of severe allergic or anaphylactic reactions to antibodies or fusion proteins