A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291588
• Other study ID #: 20060203
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2014
• Last updated: November 11, 2014
• Start date: December 2007
• Est. completion date: June 2010

Study information

• Verified date: November 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811 single subcutaneous and intravenous dose to subjects with SLE

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of SLE ncluding a positive antinuclear antibodies (ANA) test at least 6 months before randomization; any concurrent SLE pharmacologic regimen (including leflunomide, methotrexate, and anti-malarials) was stable for at least 30 days before randomization; prednisone = 20 mg/day (or equivalent) was permitted; 1 increase or decrease of = 5mg/day prednisone equivalent was allowed within 30 days before randomization

Exclusion Criteria:

• Subjects who, in the clinical judgment of the investigator, had severe disease; subject who had at least 1 BILAG 'A' score or 2 BILAG 'B' scores in any of the organ systems at screening; signs or symptoms of a viral or bacterial infection within 30 days of study randomization, or recent history of repeated infections, evidence of liver disease; concurrent receipt of mycophenolate mofetil or azathioprine; prior administration of another biologic that primarily targets the immune system within 1 year

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• AMG 811
A single dose of AMG 811 or placebo will be adminstered.
• Placebo
contains no active drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, and ECGs	Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, and ECGs	between 84 and 196 days	Yes
Secondary	Pharmacokinetic profile of AMG 811 including tmax, AUClast and Cmax	Serum concentration and derived PK parameters	between 84 and 196 days	No

External Links

•   AmgenTrials clinical trials website