Clinical Trial: A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Double-blind, Placebo-controlled, Multiple Intravenous, Ascending-Dose Study of CNTO 136 to Evaluate Safety and Pharmacokinetics in Subjects With Cutaneous Lupus Eryth

Brief Summary: The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). The secondary goal of this study was to assess the pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of action), immune response, and clinical response.

Detailed Summary: In Part A of this study, patients with CLE were randomly assigned (like flipping a coin) to receive multiple IV doses of CNTO 136, a human anti-IL 6 monoclonal antibody (an immune protein that binds to interleukin 6) or placebo (a substance that appears identical to the treatment and has no active ingredients). Patients and study personnel did not know the identity of the administered treatments (double-blind study). Increasing doses were given, based on safety data collected during the initial weeks of treatment. In Part B, which was also double-blind, patients with SLE were randomly assigned to receive multiple IV doses of the highest well-tolerated dose, as determined in Part A, of CNTO 136, or placebo.
Sponsor: Centocor Research & Development, Inc.

Current Primary Outcome:

  • Number of participants with adverse events [ Time Frame: Up to 26 weeks ]
  • Pharmacokinetic profile of CNTO 136 [ Time Frame: Up to 22 weeks ]
    Blood serum concentration over time
  • Physical examinations [ Time Frame: Up to 26 weeks ]
    Assessment of head, eyes, ears, nose and throat, skin and neck, lungs, heart, abdomen, extremities, general neurologic status, and oral examination
  • Electrocardiograms (ECGs) [ Time Frame: Up to 26 weeks ]
  • Sitting blood pressure [ Time Frame: Up to 26 weeks ]
  • Heart rate [ Time Frame: Up to 26 weeks ]
  • Respiration rate [ Time Frame: Up to 26 weeks ]
  • Oral temperature [ Time Frame: Up to 26 weeks ]
  • Hemoglobin [ Time Frame: Up to 26 weeks ]
  • Hematocrit [ Time Frame: Up to 26 weeks ]
  • Platelets and total white blood cells (WBC) [ Time Frame: Up to 26 weeks ]
  • Albumin and total protein [ Time Frame: Up to 26 weeks ]
  • Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) [ Time Frame: Up to 26 weeks ]
  • Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin [ Time Frame: Up to 26 weeks ]
  • Chlori

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Pharmacodynamics evaluations [ Time Frame: Up to 22 weeks ]
      Percentage change from baseline in serum and plasma biomarker data
    • Immune response [ Time Frame: Up to 22 weeks ]
      The formation of antibodies to CNTO 136
    • Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) [ Time Frame: Up to 22 weeks ]
      Measurement of disease activity, scored from 0 (absent) to 70 (severe), and damage, scored from 0 (absent) to 56 (severe)
    • British Isles Lupus Assessment Group (BILAG) score [ Time Frame: Up to 22 weeks ]
      Measures the need for alterations or intensification of therapy. The assessing physician considers each item as to its presence in the past month, and answers 0 = not present, 1 = improving; 2 = same; 3 = worse; or 4 = new.
    • SELENA-SLEDAI Flare Composite [ Time Frame: Up to 22 weeks ]
      Assesses the presence and severity of lupus flare. Scores range from 0 (mild) to 105 (severe).


    Original Secondary Outcome: Same as current

    Information By: Centocor Research & Development, Inc.

    Dates:
    Date Received: July 6, 2012
    Date Started: March 2007
    Date Completion:
    Last Updated: October 5, 2012
    Last Verified: October 2012