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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01702740
• Date of registration: 06/07/2012
• Prospective Registration: No
• Primary sponsor: Centocor Research & Development, Inc.
• Public title: A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus
• Scientific 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
• Date of first enrolment: March 2007
• Target sample size: 49
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01702740
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Contacts

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

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Lupus Erythematosus, Cutaneous

Intervention(s)

Drug: 1 mg/kg CNTO 136

Drug: 4 mg/kg CNTO 136

Drug: 10 mg/kg CNTO 136

Drug: Placebo

Primary Outcome(s)

Respiration rate [Time Frame: Up to 26 weeks]

Electrocardiograms (ECGs) [Time Frame: Up to 26 weeks]

Gamma-glutamyl-transferase [Time Frame: Up to 26 weeks]

Number of participants with adverse events [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]

Inorganic phosphate [Time Frame: Up to 26 weeks]

Platelets and total white blood cells (WBC) [Time Frame: Up to 26 weeks]

Bicarbonate [Time Frame: Up to 26 weeks]

Fasting Lipid Panel [Time Frame: Up to 8 weeks]

Glucose [Time Frame: Up to 26 weeks]

Heart rate [Time Frame: Up to 26 weeks]

Chloride, potassium, and sodium [Time Frame: Up to 26 weeks]

Hematocrit [Time Frame: Up to 26 weeks]

Creatine kinase [Time Frame: Up to 26 weeks]

Oral temperature [Time Frame: Up to 26 weeks]

Physical examinations [Time Frame: Up to 26 weeks]

Hemoglobin [Time Frame: Up to 26 weeks]

Lymphocytes and neutrophils [Time Frame: Up to 26 weeks]

Sitting blood pressure [Time Frame: Up to 26 weeks]

Albumin and total protein [Time Frame: Up to 26 weeks]

Pharmacokinetic profile of CNTO 136 [Time Frame: Up to 22 weeks]

Secondary Outcome(s)

Pharmacodynamics evaluations [Time Frame: Up to 22 weeks]

British Isles Lupus Assessment Group (BILAG) score [Time Frame: Up to 22 weeks]

Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) [Time Frame: Up to 22 weeks]

Immune response [Time Frame: Up to 22 weeks]

SELENA-SLEDAI Flare Composite [Time Frame: Up to 22 weeks]

Secondary ID(s)

2006-002432-25

C0136T03

CR013000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors