A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

Genentech

Status and phase

Completed

Phase 1

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: rhuMAb IFNalpha

Study type

Interventional

Funder types

Industry

Identifiers

NCT00541749

IFN3958g

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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
Evidence of significant uncontrolled concomitant diseases
Significant laboratory or electrocardiogram (ECG) abnormalities
Evidence of any clinically significant abnormality on a chest X-ray
Severly impaired renal function
Impaired hepatic function
Poorly controlled diabetes
Conditions other than SLE that could require treatment with corticosteroids
History of malignancy except completely excised basal cell carcinoma
Congenital immune deficiency
Positive tests for antibodies to HIV, hepatitis B (HBS antigen, anti-HBC) or C
Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
Frequent recurrence of herpes lesions
Episode of shingles within one year of screening
Positive screening test for latent mycobacterium tuberculosis infection
History of severe systemic bacterial, fungal, viral, or parasitic infections within the year prior to screening
Any current or recent signs or symptoms of infection
Received antibiotics orally (PO) during the 30 days prior to screening or IV antibiotics during the 60 days prior to screening
Received a live vaccine within the 30 days prior to screening
Has been hospitalized within the 30 days prior to screening
Received > 20 mg/day prednisone for > 3 days during the 30 days prior to screening
Received azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, pulse dose corticosteroids, intravenous immunoglobulin (IVIG), or transfusions within 6 months prior to screening
Received cyclophosphamide within 2 years prior to screening
Received a monoclonal antibody during the 12 months prior to screening
Previously received an investigational treatment directed against interferon alpha
Received B-cell depleting therapy (e.g., anti-CD20, anti-CD22)
Received investigational treatment during the 30 days prior to screening