An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)

Argos Therapeutics

Status and phase: Completed; Phase 1

Conditions: Inflammation; Systemic Lupus Erythematosus (SLE)

Treatments: Drug: AGS-009; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960362

AGS-009-001

Details and patient eligibility

About

This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of SLE
• Disease duration longer or equal to 6 months
• Stable, mild to moderate active SLE
• Receiving stable maintenance therapy

Exclusion criteria

• Significant lupus nephritis
• Active central nervous system (CNS) disease
• Significant arterial or venous thrombosis (blood clots) within 12 months prior to dosing
• Active vasculitis requiring treatment
• Body weight over 120 kg
• History of cancer
• Infections
• viral: HIV, hepatitis B or C, Epstein-Barr virus (EBV), cytomegalovirus (CMV), varicella zoster virus (VZV), or herpes simplex virus (HSV-1 or HSV-2)
• tuberculosis (TB)
• Severe systemic microbial infections within the past 12 months prior to dosing
• Immunosuppressive and immune modulating therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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13 participants in 7 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: placebo

B

Experimental group

Description:

Intravenous cohort 1; 0.01 mg/kg

Treatment:

Drug: AGS-009

C

Experimental group

Description:

Intravenous cohort 2; 0.1 mg/kg

Treatment:

Drug: AGS-009

D

Experimental group

Description:

Intravenous cohort 3; 0.6 mg/kg

Treatment:

Drug: AGS-009

E

Experimental group

Description:

Intravenous cohort 4; 3.0 mg/kg

Treatment:

Drug: AGS-009

F

Experimental group

Description:

Intravenous cohort 5; 10 mg/kg

Treatment:

Drug: AGS-009

G

Experimental group

Description:

Intravenous cohort 6; 30 mg/kg

Treatment:

Drug: AGS-009