A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391259
• Other study ID #: 20060132
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2015
• Last updated: March 27, 2015
• Start date: November 2006
• Est. completion date: November 2011

Study information

• Verified date: March 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of SLE with positive ANA

• Stable disease with no change in SLE therapy within the previous 30 days

• BMI from 18 to 38 kg/m2

Exclusion Criteria:

• Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization

• Evidence of renal disease or liver disease

• Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis

• Prior administration of any other biologic that primarily targets the immune system

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group 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 557
AMG 557 is for the treatment of sybjects with systemic lupus erythematosus
• Placebo
contains no active drug

Locations

Country	Name	City	State
United Kingdom	Research Site	London
United States	Research Site	Anniston	Alabama
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Manhasset	New York
United States	Research Site	Michigan City	Indiana
United States	Research Site	New York	New York
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	Phoenix	Arizona
United States	Research Site	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs	From 29 days to 169 days	Yes
Secondary	Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax	Serum concentration and derived PK parameters including Tmax, AUClast and Cmax	From 29 days to 169 days	No

External Links

•   AmgenTrials clinical trials website