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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02391259
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief 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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: AMG 557 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: AMG 557
AMG 557 administered as subcutaneous and intravenous doses.
Drug: AMG 557
AMG 557 is for the treatment of sybjects with systemic lupus erythematosus

Placebo Comparator: Placebo
No active drug
Drug: Placebo
contains no active drug




Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: From 29 days to 169 days ]
    Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs


Secondary Outcome Measures :
  1. Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax [ Time Frame: From 29 days to 169 days ]
    Serum concentration and derived PK parameters including Tmax, AUClast and Cmax



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391259


Locations
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United States, Alabama
Research Site
Anniston, Alabama, United States, 36207
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85013
United States, California
Research Site
Los Angeles, California, United States, 90033
Research Site
Los Angeles, California, United States, 90048
United States, Indiana
Research Site
Michigan City, Indiana, United States, 46360
United States, Massachusetts
Research Site
North Dartmouth, Massachusetts, United States, 02747
United States, New York
Research Site
Manhasset, New York, United States, 11030
Research Site
New York, New York, United States, 10003
Research Site
Rochester, New York, United States, 14642
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Research Site
Dallas, Texas, United States, 75231
Research Site
Dallas, Texas, United States, 75247
United Kingdom
Research Site
London, United Kingdom, NW10 7NS
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen