A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Interferon-alpha

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

• 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