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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702740
First Posted: October 8, 2012
Last Update Posted: October 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centocor Research & Development, Inc.
  Purpose
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.

Condition Intervention Phase
Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Drug: 1 mg/kg CNTO 136 Drug: 4 mg/kg CNTO 136 Drug: 10 mg/kg CNTO 136 Drug: Placebo Phase 1

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

Resource links provided by NLM:


Further study details as provided by Centocor Research & Development, Inc.:

Primary Outcome Measures:
  • 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 ]
  • Chloride, potassium, and sodium [ Time Frame: Up to 26 weeks ]
  • Bicarbonate [ Time Frame: Up to 26 weeks ]
  • Creatine kinase [ Time Frame: Up to 26 weeks ]
  • Gamma-glutamyl-transferase [ Time Frame: Up to 26 weeks ]
  • Glucose [ Time Frame: Up to 26 weeks ]
  • Lymphocytes and neutrophils [ Time Frame: Up to 26 weeks ]
  • Inorganic phosphate [ Time Frame: Up to 26 weeks ]
  • Fasting Lipid Panel [ Time Frame: Up to 8 weeks ]
    Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), and triglycerides.


Secondary Outcome Measures:
  • 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).


Enrollment: 49
Study Start Date: March 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A, 1 mg/kg CNTO 136 Drug: 1 mg/kg CNTO 136
Type=exact number, unit=mg, number=1, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
Experimental: Part A, 4 mg/kg CNTO 136 Drug: 4 mg/kg CNTO 136
Type=exact number, unit=mg, number=4, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
Experimental: Part A, 10 mg/kg CNTO 136 Drug: 10 mg/kg CNTO 136
Type=exact number, unit=mg, number=10, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
Experimental: Part B, 10 mg/kg CNTO 136/placebo Drug: 10 mg/kg CNTO 136
Type=exact number, unit=mg, number=10, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
Drug: Placebo
Form=liquid for infusion, route=intravenous use, every 2 weeks for 6 weeks.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702740


Sponsors and Collaborators
Centocor Research & Development, Inc.
Investigators
Study Director: Centocor Research & Development, Inc., PA, USA Clinical Trial Centocor Research & Development, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centocor Research & Development, Inc.
ClinicalTrials.gov Identifier: NCT01702740     History of Changes
Other Study ID Numbers: CR013000
C0136T03 ( Other Identifier: Centocor Research & Development, Inc., PA, USA )
2006-002432-25 ( EudraCT Number )
First Submitted: July 6, 2012
First Posted: October 8, 2012
Last Update Posted: October 8, 2012
Last Verified: October 2012

Keywords provided by Centocor Research & Development, Inc.:
Cutaneous lupus erythematosus
Systemic lupus erythematosus
Lupus erythematosus
Human anti-IL 6 monoclonal antibody
Sirukumab

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases