Trial record 2 of 438 for:
lupus
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:
Centocor Research & Development, Inc.
Information provided by (Responsible Party):
Centocor Research & Development, Inc.
ClinicalTrials.gov Identifier:
NCT01702740
First received: July 6, 2012
Last updated: October 5, 2012
Last verified: October 2012
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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 Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
- Pharmacokinetic profile of CNTO 136 [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: No ]Blood serum concentration over time
- Physical examinations [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Sitting blood pressure [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Heart rate [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Respiration rate [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Oral temperature [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Hemoglobin [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Hematocrit [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Platelets and total white blood cells (WBC) [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Albumin and total protein [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Chloride, potassium, and sodium [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Bicarbonate [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Creatine kinase [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Gamma-glutamyl-transferase [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Glucose [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Lymphocytes and neutrophils [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Inorganic phosphate [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Fasting Lipid Panel [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Percentage change from baseline in serum and plasma biomarker data
- Immune response [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: No ]The formation of antibodies to CNTO 136
- Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | Centocor Research & Development, Inc. |
| ClinicalTrials.gov Identifier: | NCT01702740 History of Changes |
| Other Study ID Numbers: | CR013000, C0136T03, 2006-002432-25 |
| Study First Received: | July 6, 2012 |
| Last Updated: | October 5, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
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, Cutaneous Lupus Erythematosus, Systemic Connective Tissue Diseases |
Skin Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013