A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443506
• Other study ID #: 20040147
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2015
• Last updated: May 13, 2015
• Start date: October 2004
• Est. completion date: June 2007

Study information

• Verified date: April 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 study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Men and women, between the ages of 18 and 55

• Diagnosis of SLE

• Have had a disease duration of at least 1 year, as diagnosed by a physician

Exclusion Criteria:

• Have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion

• Have active vasculitis, active CNS lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection

• Have had signs or symptoms of viral or bacterial infection within 30 days of enrollment

• Have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days

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 623
Single dose of AMG 623 administered as subcutaneous and intravenous doses
• Placebo
Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events		up to 70 days	Yes
Primary	Incidence of abnormal clinically significant vital signs		up to 70 days	Yes
Primary	Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results		up to 70 days	Yes
Primary	Incidence of abnormal clinically significant ECG results		up to 70 days	Yes
Secondary	Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax		up to 70 days	No

External Links

•   AmgenTrials clinical trials website