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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014