search
Back to results

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

Primary Purpose

Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
1 mg/kg CNTO 136
4 mg/kg CNTO 136
10 mg/kg CNTO 136
Placebo
Sponsored by
Centocor Research & Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Cutaneous focused on measuring Cutaneous lupus erythematosus, Systemic lupus erythematosus, Lupus erythematosus, Human anti-IL 6 monoclonal antibody, Sirukumab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of cutaneous lupus erythematosus (CLE, including subacute cutaneous lupus erythematosus, discoid lupus erythematosus, or lupus erythematosus tumidus) or systemic lupus erythematosus (SLE)

    • Had a body weight less than or equal to 100 kg
    • Patients in Part A who were taking systemic medications for CLE had to be on a stable dose for 4 weeks before the first study agent infusion
    • Patients in Part B taking systemic medications for SLE had to be on a stable dose for at least 3 months before the first study agent infusion
    • Given informed consent and willing and able to adhere to the study visit schedule and other protocol requirements; agreed to avoid alcohol intake; and took adequate measures to prevent pregnancy

Exclusion Criteria:

  • Significant history of or concurrent medical condition (other than lupus)
  • Use of specific previous or concurrent medications or investigational therapies
  • Known or suspected allergy to the study agent or it constituents, having recently donated blood, or having any significant laboratory test values requiring intervention
  • Patients with SLE in Part B could not have active central nervous system lupus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Part A, 1 mg/kg CNTO 136

    Part A, 4 mg/kg CNTO 136

    Part A, 10 mg/kg CNTO 136

    Part B, 10 mg/kg CNTO 136/placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of participants with adverse events
    Pharmacokinetic profile of CNTO 136
    Blood serum concentration over time
    Physical examinations
    Assessment of head, eyes, ears, nose and throat, skin and neck, lungs, heart, abdomen, extremities, general neurologic status, and oral examination
    Electrocardiograms (ECGs)
    Sitting blood pressure
    Heart rate
    Respiration rate
    Oral temperature
    Hemoglobin
    Hematocrit
    Platelets and total white blood cells (WBC)
    Albumin and total protein
    Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST)
    Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin
    Chloride, potassium, and sodium
    Bicarbonate
    Creatine kinase
    Gamma-glutamyl-transferase
    Glucose
    Lymphocytes and neutrophils
    Inorganic phosphate
    Fasting Lipid Panel
    Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), and triglycerides.

    Secondary Outcome Measures

    Pharmacodynamics evaluations
    Percentage change from baseline in serum and plasma biomarker data
    Immune response
    The formation of antibodies to CNTO 136
    Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
    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
    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
    Assesses the presence and severity of lupus flare. Scores range from 0 (mild) to 105 (severe).

    Full Information

    First Posted
    July 6, 2012
    Last Updated
    October 5, 2012
    Sponsor
    Centocor Research & Development, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01702740
    Brief Title
    A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus
    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 Erythematosus and to Evaluate Safety and Pharmacokinetics in a Cohort of Subjects With Systemic Lupus Erythematosus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centocor Research & Development, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
    Keywords
    Cutaneous lupus erythematosus, Systemic lupus erythematosus, Lupus erythematosus, Human anti-IL 6 monoclonal antibody, Sirukumab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part A, 1 mg/kg CNTO 136
    Arm Type
    Experimental
    Arm Title
    Part A, 4 mg/kg CNTO 136
    Arm Type
    Experimental
    Arm Title
    Part A, 10 mg/kg CNTO 136
    Arm Type
    Experimental
    Arm Title
    Part B, 10 mg/kg CNTO 136/placebo
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    1 mg/kg CNTO 136
    Intervention Description
    Type=exact number, unit=mg, number=1, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    4 mg/kg CNTO 136
    Intervention Description
    Type=exact number, unit=mg, number=4, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    10 mg/kg CNTO 136
    Intervention Description
    Type=exact number, unit=mg, number=10, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Form=liquid for infusion, route=intravenous use, every 2 weeks for 6 weeks.
    Primary Outcome Measure Information:
    Title
    Number of participants with adverse events
    Time Frame
    Up to 26 weeks
    Title
    Pharmacokinetic profile of CNTO 136
    Description
    Blood serum concentration over time
    Time Frame
    Up to 22 weeks
    Title
    Physical examinations
    Description
    Assessment of head, eyes, ears, nose and throat, skin and neck, lungs, heart, abdomen, extremities, general neurologic status, and oral examination
    Time Frame
    Up to 26 weeks
    Title
    Electrocardiograms (ECGs)
    Time Frame
    Up to 26 weeks
    Title
    Sitting blood pressure
    Time Frame
    Up to 26 weeks
    Title
    Heart rate
    Time Frame
    Up to 26 weeks
    Title
    Respiration rate
    Time Frame
    Up to 26 weeks
    Title
    Oral temperature
    Time Frame
    Up to 26 weeks
    Title
    Hemoglobin
    Time Frame
    Up to 26 weeks
    Title
    Hematocrit
    Time Frame
    Up to 26 weeks
    Title
    Platelets and total white blood cells (WBC)
    Time Frame
    Up to 26 weeks
    Title
    Albumin and total protein
    Time Frame
    Up to 26 weeks
    Title
    Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST)
    Time Frame
    Up to 26 weeks
    Title
    Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin
    Time Frame
    Up to 26 weeks
    Title
    Chloride, potassium, and sodium
    Time Frame
    Up to 26 weeks
    Title
    Bicarbonate
    Time Frame
    Up to 26 weeks
    Title
    Creatine kinase
    Time Frame
    Up to 26 weeks
    Title
    Gamma-glutamyl-transferase
    Time Frame
    Up to 26 weeks
    Title
    Glucose
    Time Frame
    Up to 26 weeks
    Title
    Lymphocytes and neutrophils
    Time Frame
    Up to 26 weeks
    Title
    Inorganic phosphate
    Time Frame
    Up to 26 weeks
    Title
    Fasting Lipid Panel
    Description
    Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), and triglycerides.
    Time Frame
    Up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Pharmacodynamics evaluations
    Description
    Percentage change from baseline in serum and plasma biomarker data
    Time Frame
    Up to 22 weeks
    Title
    Immune response
    Description
    The formation of antibodies to CNTO 136
    Time Frame
    Up to 22 weeks
    Title
    Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
    Description
    Measurement of disease activity, scored from 0 (absent) to 70 (severe), and damage, scored from 0 (absent) to 56 (severe)
    Time Frame
    Up to 22 weeks
    Title
    British Isles Lupus Assessment Group (BILAG) score
    Description
    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.
    Time Frame
    Up to 22 weeks
    Title
    SELENA-SLEDAI Flare Composite
    Description
    Assesses the presence and severity of lupus flare. Scores range from 0 (mild) to 105 (severe).
    Time Frame
    Up to 22 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of cutaneous lupus erythematosus (CLE, including subacute cutaneous lupus erythematosus, discoid lupus erythematosus, or lupus erythematosus tumidus) or systemic lupus erythematosus (SLE) Had a body weight less than or equal to 100 kg Patients in Part A who were taking systemic medications for CLE had to be on a stable dose for 4 weeks before the first study agent infusion Patients in Part B taking systemic medications for SLE had to be on a stable dose for at least 3 months before the first study agent infusion Given informed consent and willing and able to adhere to the study visit schedule and other protocol requirements; agreed to avoid alcohol intake; and took adequate measures to prevent pregnancy Exclusion Criteria: Significant history of or concurrent medical condition (other than lupus) Use of specific previous or concurrent medications or investigational therapies Known or suspected allergy to the study agent or it constituents, having recently donated blood, or having any significant laboratory test values requiring intervention Patients with SLE in Part B could not have active central nervous system lupus
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Centocor Research & Development, Inc., PA, USA Clinical Trial
    Organizational Affiliation
    Centocor Research & Development, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23896980
    Citation
    Szepietowski JC, Nilganuwong S, Wozniacka A, Kuhn A, Nyberg F, van Vollenhoven RF, Bengtsson AA, Reich A, de Vries DE, van Hartingsveldt B, Robinson DW Jr, Gordon R, Hsu B. Phase I, randomized, double-blind, placebo-controlled, multiple intravenous, dose-ascending study of sirukumab in cutaneous or systemic lupus erythematosus. Arthritis Rheum. 2013 Oct;65(10):2661-71. doi: 10.1002/art.38091.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs