NCT01702740

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2007

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

2.6 years

First QC Date

July 6, 2012

Last Update Submit

October 5, 2012

Conditions

Lupus Erythematosus, CutaneousLupus Erythematosus, Systemic

Keywords

Cutaneous lupus erythematosusSystemic lupus erythematosusLupus erythematosusHuman anti-IL 6 monoclonal antibodySirukumab

Outcome Measures

Primary Outcomes (22)

  • Number of participants with adverse events

    Up to 26 weeks

  • Pharmacokinetic profile of CNTO 136

    Blood serum concentration over time

    Up to 22 weeks

  • Physical examinations

    Assessment of head, eyes, ears, nose and throat, skin and neck, lungs, heart, abdomen, extremities, general neurologic status, and oral examination

    Up to 26 weeks

  • Electrocardiograms (ECGs)

    Up to 26 weeks

  • Sitting blood pressure

    Up to 26 weeks

  • Heart rate

    Up to 26 weeks

  • Respiration rate

    Up to 26 weeks

  • Oral temperature

    Up to 26 weeks

  • Hemoglobin

    Up to 26 weeks

  • Hematocrit

    Up to 26 weeks

  • Platelets and total white blood cells (WBC)

    Up to 26 weeks

  • Albumin and total protein

    Up to 26 weeks

  • Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST)

    Up to 26 weeks

  • Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin

    Up to 26 weeks

  • Chloride, potassium, and sodium

    Up to 26 weeks

  • Bicarbonate

    Up to 26 weeks

  • Creatine kinase

    Up to 26 weeks

  • Gamma-glutamyl-transferase

    Up to 26 weeks

  • Glucose

    Up to 26 weeks

  • Lymphocytes and neutrophils

    Up to 26 weeks

  • Inorganic phosphate

    Up to 26 weeks

  • Fasting Lipid Panel

    Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), and triglycerides.

    Up to 8 weeks

Secondary Outcomes (5)

  • Pharmacodynamics evaluations

    Up to 22 weeks

  • Immune response

    Up to 22 weeks

  • Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)

    Up to 22 weeks

  • British Isles Lupus Assessment Group (BILAG) score

    Up to 22 weeks

  • SELENA-SLEDAI Flare Composite

    Up to 22 weeks

Study Arms (4)

Part A, 1 mg/kg CNTO 136

EXPERIMENTAL
Drug: 1 mg/kg CNTO 136

Part A, 4 mg/kg CNTO 136

EXPERIMENTAL
Drug: 4 mg/kg CNTO 136

Part A, 10 mg/kg CNTO 136

EXPERIMENTAL
Drug: 10 mg/kg CNTO 136

Part B, 10 mg/kg CNTO 136/placebo

EXPERIMENTAL
Drug: 10 mg/kg CNTO 136Drug: Placebo

Interventions

1 mg/kg CNTO 136DRUG

Type=exact number, unit=mg, number=1, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.

Part A, 1 mg/kg CNTO 136
4 mg/kg CNTO 136DRUG

Type=exact number, unit=mg, number=4, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.

Part A, 4 mg/kg CNTO 136
10 mg/kg CNTO 136DRUG

Type=exact number, unit=mg, number=10, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.

Part A, 10 mg/kg CNTO 136Part B, 10 mg/kg CNTO 136/placebo
PlaceboDRUG

Form=liquid for infusion, route=intravenous use, every 2 weeks for 6 weeks.

Part B, 10 mg/kg CNTO 136/placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23896980DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, CutaneousLupus Erythematosus, Systemic

Interventions

sirukumab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Centocor Research & Development, Inc., PA, USA Clinical Trial

    Centocor Research & Development, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

October 8, 2012

Study Start

March 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 8, 2012

Record last verified: 2012-10