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

NCT01702740 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-10-08

No results posted yet for this study

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.

Conditions

  • Lupus Erythematosus, Cutaneous
  • Lupus Erythematosus, Systemic

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Centocor Research & Development, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-10-31
Completion
2009-10-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01702740 on ClinicalTrials.gov