A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

September 21, 2011 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Systemic Lupus Erythematosus

Intervention / Treatment

Drug: rhuMAb IFNalpha

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence and nature of laboratory abnormalities Time Frame: Length of study	Length of study
The incidence, nature, and severity of adverse events Time Frame: Length of study	Length of study

Secondary Outcome Measures

Outcome Measure	Time Frame
The PK profile of rhuMAb IFNalpha Time Frame: Length of study	Length of study
The incidence of antibodies directed against rhuMAb IFNalpha Time Frame: Length of study	Length of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

Study Director: Jorn Drappa, M.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

McBride JM, Jiang J, Abbas AR, Morimoto A, Li J, Maciuca R, Townsend M, Wallace DJ, Kennedy WP, Drappa J. Safety and pharmacodynamics of rontalizumab in patients with systemic lupus erythematosus: results of a phase I, placebo-controlled, double-blind, dose-escalation study. Arthritis Rheum. 2012 Nov;64(11):3666-76. doi: 10.1002/art.34632.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Registration Dates

First Submitted

October 7, 2007

First Submitted That Met QC Criteria