A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00541749
First received: October 7, 2007
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: rhuMAb IFNalpha
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • The incidence and nature of laboratory abnormalities [ Time Frame: Length of study ]
  • The incidence, nature, and severity of adverse events [ Time Frame: Length of study ]

Secondary Outcome Measures:
  • The PK profile of rhuMAb IFNalpha [ Time Frame: Length of study ]
  • The incidence of antibodies directed against rhuMAb IFNalpha [ Time Frame: Length of study ]

Estimated Enrollment: 60
Study Start Date: February 2007
Intervention Details:
    Drug: rhuMAb IFNalpha
    Intravenous repeating dose
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541749

Sponsors and Collaborators
Genentech
Investigators
Study Director: Jorn Drappa, M.D. Genentech
  More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00541749     History of Changes
Other Study ID Numbers: IFN3958g
Study First Received: October 7, 2007
Last Updated: September 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014