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

NCT ID: NCT01702740

Last Updated: 2012-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-10-31

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.

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.

Conditions

Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic

Keywords

Cutaneous lupus erythematosus; Systemic lupus erythematosus; Lupus erythematosus; Human anti-IL 6 monoclonal antibody; Sirukumab

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A, 1 mg/kg CNTO 136

Group Type: EXPERIMENTAL

1 mg/kg CNTO 136

Intervention Type: DRUG

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

Part A, 4 mg/kg CNTO 136

Group Type: EXPERIMENTAL

4 mg/kg CNTO 136

Intervention Type: DRUG

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

Part A, 10 mg/kg CNTO 136

Group Type: EXPERIMENTAL

10 mg/kg CNTO 136

Intervention Type: DRUG

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

Part B, 10 mg/kg CNTO 136/placebo

Group Type: EXPERIMENTAL

10 mg/kg CNTO 136

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor Research & Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Centocor Research & Development, Inc.

References

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.

Reference Type: DERIVED

PMID: 23896980 (View on PubMed)

Other Identifiers

C0136T03

Identifier Type: OTHER

Identifier Source: secondary_id

2006-002432-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR013000

Identifier Type: -

Identifier Source: org_study_id